Bloom Science Initiates Phase 1b Obesity Trial of BL-001, Advancing a Differentiated Approach Beyond GLP-1

  • First patient dosed in Phase 1b randomized, placebo-controlled study evaluating safety, tolerability and weight loss over 12 weeks
  • Market research indicates strong demand for ketogenic-metabolic approaches, including among adults with obesity who are not currently receiving treatment
  • BL-001 positioned as a potential oral ketogenic-metabolic therapy designed for gradual, sustained weight loss with improved tolerability

SAN DIEGO, Feb. 24, 2026 /PRNewswire/ — Bloom Science, Inc., a clinical-stage biotech company focused on the development of novel therapies for metabolic and neurological disorders, today announced that the first patient has been dosed in its Phase 1b clinical trial evaluating BL-001 in adults with obesity.

The Phase 1b study (BL-001-1201) is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, and weight loss effects of daily oral BL-001 administered for 12 weeks in adults with obesity. The study will enroll up to 48 participants across two clinical sites in Australia.

BL-001 is an investigational oral Live Biotherapeutic Product (LBP) designed to replicate key metabolic effects of the ketogenic diet without requiring dietary restriction.

In a previously completed Phase 1 study in healthy adults, BL-001 was well tolerated with no serious adverse events reported. Among overweight participants, statistically significant placebo-adjusted weight loss was observed, accompanied by dose-dependent BL-001 strain kinetics and metabolic changes consistent with engagement of ketogenic pathways.

Addressing a Critical Gap in the Obesity Market
Despite the significant clinical impact of GLP-1 receptor agonists, the majority of the more than 100 million American adults living with obesity remain untreated. While GLP-1 therapies have proven effective for many who initiate and persist on treatment, real-world adoption has been constrained by factors beyond access and cost. Many patients are reluctant to initiate injectable therapy, citing concerns about gastrointestinal and other side effects or seeking alternatives aligned with natural metabolic biology. These patients are not failing treatment – they are choosing not to start it.

Bloom Science believes these patients represent demand for a differentiated therapeutic mechanism rather than incremental optimization of existing approaches. BL-001 is designed to be that option: a naturally inspired, orally delivered therapy rooted in ketogenic biology and developed with the full rigor of a pharmaceutical product.

“Millions of patients remain untreated because existing therapies do not align with their preferences,” said Christopher Reyes, PhD, Chief Executive Officer of Bloom Science. “BL-001 is designed to change that, delivering the metabolic benefits of the ketogenic diet in a daily oral capsule, without injections or dietary restriction.”

Recent market research conducted among several thousand U.S. adults, including a large cohort of individuals living with obesity, supports this positioning. A substantial majority of respondents expressed strong interest in a ketogenic-metabolic approach, and this preference remained high even among those with prior GLP-1 experience. Bloom believes BL-001 has the potential to serve as stand-alone oral therapy while expanding the obesity market beyond patients currently treated with incretin therapies and offering complementary use alongside or following those treatments.

Respondents expressed clear preference for gradual, sustained weight loss with durable results over rapid initial weight loss associated with higher tolerability burden. When presented with the BL-001 concept alongside GLP-1 profiles, respondents chose the BL-001 concept at higher rates than GLP-1-based approaches, with particular interest in the keto-like mechanism.

“This is about bringing a real treatment option to patients who are currently on the sidelines,” said Louis Licamele, PhD, Chief Development Officer of Bloom Science. “Advancing into a dedicated obesity program is a milestone not just for Bloom, but for the patients who have been waiting for something different.”

BL-001 is being developed across both metabolic and neurologic indications, including obesity and Developmental & Epileptic Encephalopathies (DEEs), reflecting Bloom’s strategy to leverage ketogenic biology across chronic diseases.

About BL-001
BL-001 is a potential first-in-class, orally delivered, Live Biotherapeutic Product (LBP) candidate being developed by Bloom Science. BL-001 is designed to translate the therapeutic effects of the ketogenic diet into a scalable, pharmaceutical-grade oral therapy with potential utility across both metabolic and neurologic indications. Preclinical data have demonstrated replication of the ketogenic diet therapeutic effect in epilepsy models and have further demonstrated modulation of gamma-aminobutyric acid (GABA) and other key bioenergetic pathways to suppress hyperexcitability, which is a key driver in seizures.

About the Ketogenic Diet
The ketogenic diet is a medical diet initially developed in 1921 to mimic fasting as a treatment for epilepsy. The ketogenic diet is very low in carbohydrates and high in fat and is used to treat epilepsy in children. There is accumulating clinical evidence that the diet is effective for weight loss, reversal of metabolic dysfunction and treating mental illness in certain patients. Despite its well-documented benefits for patients, the ketogenic diet can be challenging to maintain long term.

About Bloom Science
Bloom Science is a clinical-stage biotechnology company developing new therapies for neurological disorders and metabolic diseases, including obesity. Rooted in gut-brain axis biology and microbiome science, Bloom’s therapeutic approach is designed to replicate key metabolic effects of the ketogenic diet. Bloom Science is headquartered in San Diego, California. For more information, visit: https://bloomscience.com/

Forward-Looking Statement
This press release contains forward-looking statements regarding Bloom Science’s clinical programs, including BL-001, and their potential therapeutic and commercial value. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. Bloom Science disclaims any obligation to update such statements except as required by law.

Media Contact:
Kathy Fowler
kathleen@onthemarcmedia.com
(410) 963-2345

Bloom Science Announces Poster Presentations at Obesity Week 2025

SAN DIEGO, Calif., November 4, 2025 – Bloom Science, Inc., a clinical-stage biotech company focused on the development of novel therapies for metabolic and neurological disorders, today announced that clinical data from the company’s BL-001 program will be highlighted in a poster presentations at the 2025 ObesityWeek.  BL-001 is a first-in-class, orally delivered, Live Biotherapeutic Product (LBP) designed to replicate the therapeutic effects of the Ketogenic Diet being developed for weight loss in obesity and the potential treatment of Dravet Syndrome and DEEs (Developmental and Epileptic Encephalopathies). The 2025 ObesityWeek is being held November 4-7th in Atlanta, GA.

The presentation will summarize results from the company’s Phase 1 clinical trial, a randomized, double-blind, placebo-controlled MAD (multiple ascending dose) study evaluating 28 days of daily treatment with an oral formulation of BL-001 in healthy subjects. 

Details of the presentations are as follows:

Title: Safety, Tolerability, and Efficacy of BL-001, an Oral LBP, for Weight Loss in Healthy Volunteers

Presenting Author: Louis Licamele, PhD, Chief Development Officer, Bloom Science

Date/Time: Thursday, November 6, 2025, 2:30-3:30 p.m. EST

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Poster #2.414:

    Title: Selection of Lead Candidate Bacteria for BL-001, a Live Biotherapeutic Product in Development for the Treatment of Neurological Indications

    Presenting Author: Lisa Elmén, PhD, Sr Scientist and Andra Ionescu Tucker, PhD, Scientist, Bloom Science

    Date/Time: Sunday, December 8, 2024, 12-2:00 p.m. PST

    Location: Exhibit Hall Los Angeles Convention Center

    About BL-001 and the Ketogenic Diet

    BL-001 is a first-in-class, orally delivered, Live Biotherapeutic Product (LBP) being developed by Bloom Science. BL-001 is designed to replicate the therapeutic effects of the ketogenic diet. Preclinical data has demonstrated replication of the ketogenic diet therapeutic effect in epilepsy models and further demonstrated modulation of gamma aminobutyric acid (GABA) and other key bioenergetic pathways to suppress hyperexcitability which is a key driver in seizures.

    The ketogenic diet was initially developed in 1921 to mimic fasting as a treatment for epilepsy. The ketogenic diet is a medical diet that is very-low in carbohydrates and high in fat used to treat epilepsy in children but there is accumulating clinical evidence that the diet is effective for weight loss, reversing metabolic dysfunction and treating mental illness. While the ketogenic diet has been shown to work quite well for patients, it can be an incredible challenge to maintain indefinitely.

    About Bloom Science, Inc. 

    Bloom Science, Inc. is a clinical-stage biotech company focused on the development of novel first-in-class therapies for the treatment of metabolic and neurological disorders. Bloom’s research and development activities leverage its expertise in gut-brain axis biology, metabolism and the microbiome to develop innovative therapeutics designed to improve patients’ lives. Bloom’s clinical programs include BL-001, a first-in-class, orally delivered, Live Biotherapeutic Product (LBP) designed to replicate the therapeutic effects of the Ketogenic Diet. Bloom’s proprietary discovery platform, IrisRx™ enables a fundamentally different approach to developing medicines by harnessing our expanding insight into the Gut-Brain Axis to design and develop therapeutics that target novel biology with superior safety profiles. Bloom Science is advancing a deep pipeline of programs, focused in Obesity, Dravet syndrome and DEEs, Amyotrophic Lateral Sclerosis (ALS), and other neurodegenerative and cognitive disorders.

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Bloom Science Reports Positive Data from Phase 1 Trial of BL-001

    BL-001 achieved statistically significant placebo-adjusted mean weight loss at 28 days in overweight subjects

    Overweight individuals in highest dose group experiencing weight loss at day 28 continued to lose weight as assessed 2 weeks after last dose

    Dose-dependent metabolic changes mimicking the ketogenic diet observed

    Clinical data on the potential ketogenic effect of BL-001 supports advancing into Phase 2 trials in both obesity and DEE (Dravet syndrome)

    SAN DIEGO, March 4, 2025 /PRNewswire/ — Bloom Science, Inc., a clinical-stage biotech company focused on the development of novel therapies for metabolic and neurological disorders, today announced that BL-001, an investigational oral therapy designed to replicate the positive effects of the ketogenic diet, demonstrated statistically significant placebo-adjusted weight loss at 28 days in a Phase 1 trial of 32 healthy adults ranging from healthy weight to overweight. The randomized, double-blind, placebo-controlled trial assessed safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BL-001 when dosed once-daily (QD).

    The overall treatment effect of BL-001 on weight loss (all treated BL-001 (n=24) vs Placebo (n=8)) was statistically significant (p=0.0424; MMRM, mixed model repeated measures) over the 28-day treatment period. Previously reported clinical trial results showed that BL-001 was well tolerated with minimal adverse events.

    The percent weight change of the BL-001 treated overweight (BMI >= 25) subjects vs all subjects who received placebo (pooled) is statistically significant (p=0.0007, LS mean change -2.3% body weight change). The percent weight change between overweight and healthy weight individuals treated with BL-001 is also statistically significant (p=0.0003, LS mean change -2.2% body weight change). The highest recorded weight loss was 4.9%.

    Additionally, 80% of the subjects who experienced weight loss during BL-001 treatment maintained a weight loss compared to their baseline body weight two weeks after their last dose. Of these, 100% of the overweight subjects receiving the highest dose continued to lose weight, resulting in 3.4% weight loss by the end of the 2-week follow-up period.

    Ketogenic metabolic changes, including urinary ketones and reduced appetite, and weight loss were observed in the BL-001 treated subjects in a dose-dependent manner and not in placebo. Targeted biomarker analysis revealed statistically significant changes in key metabolic hormones involved in appetite control, metabolic regulation, and digestion. Additionally, a larger metabolomics analysis revealed statistically significant changes in circulating ketone bodies. These findings further support the potential ketogenic and weight loss effects, strengthening confidence in the biological activity of BL-001.

    “We believe BL-001 represents a groundbreaking approach to obesity treatment, with the potential to address the limitations of existing therapies by offering a safer, naturally inspired, multi-pathway solution,” said Louis Licamele, PhD, Chief Development Officer of Bloom Science. “We are excited by the current data and remain dedicated to developing a more patient-friendly alternative to current treatments that can provide sustainable weight loss while improving long-term compliance and outcomes.”

    BL-001 has previously been shown to replicate the effects of the ketogenic diet and prevent seizures in multiple animal models. Following the positive results from the Phase 1 trial, Bloom Science plans to study BL-001 for the treatment of Dravet syndrome and other Developmental and Epileptic Encephalopathies. The latest analysis also supports Bloom’s plans to initiate a Phase 2 study in an obese population in 2026.

    “While the ketogenic diet has long been known for its therapeutic effects, BL-001’s potential to replicate its benefits in a more tolerable form of daily oral capsules opens exciting possibilities for patients,” said Christopher Reyes, PhD, Chief Executive Officer of Bloom Science. “This validation supports our continued clinical efforts targeting both obesity and Dravet Syndrome.”

    About BL-001 and the Ketogenic Diet
    BL-001 is a potential first-in-class, orally delivered, Live Biotherapeutic Product (LBP) candidate being developed by Bloom Science. BL-001 is designed to replicate the therapeutic effects of the ketogenic diet. Preclinical data has demonstrated replication of the ketogenic diet therapeutic effect in epilepsy models and further demonstrated modulation of gamma-aminobutyric acid (GABA) and other key bioenergetic pathways to suppress hyperexcitability, which is a key driver in seizures.

    The ketogenic diet is a medical diet initially developed in 1921 to mimic fasting as a treatment for epilepsy. The ketogenic diet is very-low in carbohydrates and high in fat, and is used to treat epilepsy in children. There is accumulating clinical evidence that the diet may be effective for weight loss, reversing metabolic dysfunction and treating mental illness in certain patients. Despite its well-documented benefits for patients, the ketogenic diet can be an incredible challenge to maintain long term. A ketogenic diet mimetic like BL-001 has the potential to therefore offer substantial value to patients who benefit from such diet.

    About Bloom Science
    Bloom Science, Inc. is a clinical-stage biotech company focused on the development of novel first-in-class therapies for the treatment of metabolic and neurological disorders. Bloom’s research and development activities leverage its expertise in gut-brain axis biology, metabolism and the microbiome to develop innovative therapeutics designed to improve patients’ lives. Bloom’s clinical programs include BL-001, a first-in-class, orally delivered, LBP designed to replicate the therapeutic effects of the Ketogenic Diet. Bloom’s proprietary discovery platform, IrisRx enables a fundamentally different approach to developing medicines by harnessing our expanding insight into the Gut-Brain Axis to design and develop therapeutics that target novel biology with superior safety profiles. Bloom Science is advancing a deep pipeline of programs, focused on obesity, Dravet syndrome and Developmental and Epileptic Encephalopathies (DEEs), Amyotrophic Lateral Sclerosis (ALS), and other neurodegenerative and cognitive disorders.

    For More Information: https://bloomscience.com/

    Forward-Looking Statement
    This press release may contain “forward-looking statements,” including statements by Dr. Reyes, Dr. Licamele or other persons on Bloom Science’s behalf and statements regarding Bloom Science’s expectations about any of the following: (i) the safety, efficacy and clinical progress of our various clinical programs, including our BL-001 program; (ii) the status of clinical trials (including activities at clinical trial sites); (iii) the data generated by ongoing and planned clinical trials, and the ability to use that data for the design and initiation of further clinical trials; and (iv) the therapeutic value, development, and commercial potential of Bloom Science Live Biotherapeutic Products. The words “believes,” “anticipates,” “plans,” “expects,”  “potential” and similar expressions are intended to identify forward-looking statements. You are cautioned that forward-looking statements are inherently uncertain. Although Bloom Science believes such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, forward-looking statements are neither promises nor guarantees and are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Bloom Science disclaims any obligation or undertaking to update or revise any forward-looking statements, other than as required by law.     

    Media Contact:
    Kathy Silverstein
    kathleen@onthemarcmedia.com
    410-963-2345

     

     

     

     

     

     

     

     

     

     

    Bloom Science to Present at the Sachs 8th Annual Neuroscience Innovation Forum

    SAN DIEGO, Calif., January 10, 2025 – Bloom Science, Inc., a clinical-stage biotech company focused on the development of novel therapies for metabolic and neurological disorders, today announced that its Chief Executive Officer, Christopher Reyes, Ph.D., will participate as a panelist  of experts focused on next-generation modalities in rare neurological diseases.

     

    Dr. Reyes will also deliver a presentation focused on Bloom’s program and clinical data for BL-001 for the potential treatment of Dravet Syndrome and other DEEs (Developmental and Epileptic Encephalopathies) at the Sachs Associates 8th Annual Neuroscience Innovation Forum.  The conference will take place January 12, 2025, in San Francisco, California preceding the 43rd Annual J.P. Morgan Healthcare Conference.

    Details of the panel are as follows:

    • 8th Annual Neuroscience Innovation Forum
      Details: Dr. Reyes will a panelist for the session: NextGen Modalities for Rare & Orphan Neurological Diseases
      Conference dates: January 12, 2025
      Presentation Timing: 11:00 a.m. PST

    Details of the presentations are as follows:

    • 8th Annual Neuroscience Innovation Forum
      Details: Dr. Reyes will deliver a presentation and participate in 1-on-1 meetings
      Conference dates: January 11, 2025
      Presentation Timing: 3:45 p.m. PST

     

    About Bloom Science, Inc. 

    Bloom Science, Inc. is a clinical-stage biotech company focused on the development of novel first-in-class therapies for the treatment of metabolic and neurological disorders. Bloom’s research and development activities leverage its expertise in gut-brain axis biology, metabolism and the microbiome to develop innovative therapeutics designed to improve patients’ lives. Bloom’s clinical programs include BL-001, a first-in-class, orally delivered, Live Biotherapeutic Product (LBP) designed to replicate the therapeutic effects of the Ketogenic Diet. Bloom’s proprietary discovery platform, IrisRx™ enables a fundamentally different approach to developing medicines by harnessing our expanding insight into the Gut-Brain Axis to design and develop therapeutics that target novel biology with superior safety profiles. Bloom Science is advancing a deep pipeline of programs, focused in obesity, Dravet syndrome and DEEs, Amyotrophic Lateral Sclerosis (ALS), and other neurodegenerative and cognitive disorders.

     

     

     

     

     

    Bloom Science to Present at the Sachs 1st Annual Biopharma Obesity Innovation Forum

    SAN DIEGO, Calif., January 9, 2025 – Bloom Science, Inc., a clinical-stage biotech company focused on the development of novel therapies for metabolic and neurological disorders, today announced that its Chief Executive Officer, Christopher Reyes, Ph.D., will deliver a presentation focused on Bloom’s obesity program and clinical data at the Sachs Associates 1st Annual Biopharma Obesity Innovation Forum. The conference will take place January 11, 2025, in San Francisco, California preceding the 43rd Annual J.P. Morgan Healthcare Conference.

     

    Details of the presentations are as follows:

    • 1st Annual Biopharma Obesity Innovation Forum
      Details: Dr. Reyes will deliver a presentation and participate in 1-on-1 meetings
      Conference dates: January 11, 2025
      Presentation Timing: 2:20 p.m. PST

    About Bloom Science, Inc. 

    Bloom Science, Inc. is a clinical-stage biotech company focused on the development of novel first-in-class therapies for the treatment of metabolic and neurological disorders. Bloom’s research and development activities leverage its expertise in gut-brain axis biology, metabolism and the microbiome to develop innovative therapeutics designed to improve patients’ lives. Bloom’s clinical programs include BL-001, a first-in-class, orally delivered, Live Biotherapeutic Product (LBP) designed to replicate the therapeutic effects of the Ketogenic Diet. Bloom’s proprietary discovery platform, IrisRx™ enables a fundamentally different approach to developing medicines by harnessing our expanding insight into the Gut-Brain Axis to design and develop therapeutics that target novel biology with superior safety profiles. Bloom Science is advancing a deep pipeline of programs, focused in obesity, Dravet syndrome and DEEs, Amyotrophic Lateral Sclerosis (ALS), and other neurodegenerative and cognitive disorders.

     

     

     

     

     

    Bloom Science Announces Poster Presentations at the 2024 American Epilepsy Society Annual Meeting

    SAN DIEGO, Calif., December 5, 2024 – Bloom Science, Inc., a clinical-stage biotech company focused on the development of novel therapies for metabolic and neurological disorders, today announced that preclinical and clinical data from the company’s BL-001 program will be highlighted in three poster presentations at the 2024 American Epilepsy Society Annual Meeting.  BL-001 is a first-in-class, orally delivered, Live Biotherapeutic Product (LBP) designed to replicate the therapeutic effects of the Ketogenic Diet being developed for the potential treatment of Dravet Syndrome and DEEs (Developmental and Epileptic Encephalopathies). The 2024 American Epilespy Society Annual Meeting is being held December 6-10 in Los Angeles, CA

     

    One presentation will summarize results from the company’s Phase 1 clinical trial, a randomized, double-blind, placebo-controlled MAD (multiple ascending dose) study evaluating 28 days of daily treatment with an oral formulation of BL-001 in healthy subjects.  A second presentation will highlight results from the company’s Phase 0 exploratory clinical study in healthy volunteers of BL-001 to assess strain kinetics and tolerability, followed by fecal microbiota transplant from volunteer-to-mice for seizure protection testing. A third presentation will focus on preclinical development data for BL-001 demonstrating anticonvulsive efficacy in multiple mouse models of epilepsy and in vitro modulation of neuronal hyperexcitation, neuroinflammation, and increased integrity of blood brain barrier and gut barrier.

    Details of the presentations are as follows:

    Poster #2.373:

    Title: Safety, Tolerability, and Strain Kinetics of BL-001, an Orally Delivered Live Biotherapeutic Product, in a Phase 1 Study of Healthy Volunteers

    Presenting Author: Louis Licamele, PhD, Chief Development Officer, Bloom Science

    Date/Time: Sunday, December 8, 2024, 12-2:00 p.m. PST

    Location: Exhibit Hall Los Angeles Convention Center

    Poster #2.413:

    Title: Reverse Translational Validation of Anti-Epileptic Effect of Prototype BL-001 in a Preclinical Seizure Model from a Phase 0 Trial in Healthy Volunteers

    Presenting Author: Brent Nowinski, PhD, Scietnist, Bloom Science

    Date/Time: Sunday, December 8, 2024, 12-2:00 p.m. PST

    Location: Exhibit Hall Los Angeles Convention Center

       

      Poster #2.414:

      Title: Selection of Lead Candidate Bacteria for BL-001, a Live Biotherapeutic Product in Development for the Treatment of Neurological Indications

      Presenting Author: Lisa Elmén, PhD, Sr Scientist and Andra Ionescu Tucker, PhD, Scientist, Bloom Science

      Date/Time: Sunday, December 8, 2024, 12-2:00 p.m. PST

      Location: Exhibit Hall Los Angeles Convention Center

      About BL-001 and the Ketogenic Diet

      BL-001 is a first-in-class, orally delivered, Live Biotherapeutic Product (LBP) being developed by Bloom Science. BL-001 is designed to replicate the therapeutic effects of the ketogenic diet. Preclinical data has demonstrated replication of the ketogenic diet therapeutic effect in epilepsy models and further demonstrated modulation of gamma aminobutyric acid (GABA) and other key bioenergetic pathways to suppress hyperexcitability which is a key driver in seizures.

      The ketogenic diet was initially developed in 1921 to mimic fasting as a treatment for epilepsy. The ketogenic diet is a medical diet that is very-low in carbohydrates and high in fat used to treat epilepsy in children but there is accumulating clinical evidence that the diet is effective for weight loss, reversing metabolic dysfunction and treating mental illness. While the ketogenic diet has been shown to work quite well for patients, it can be an incredible challenge to maintain indefinitely.

      About Bloom Science, Inc. 

      Bloom Science, Inc. is a clinical-stage biotech company focused on the development of novel first-in-class therapies for the treatment of metabolic and neurological disorders. Bloom’s research and development activities leverage its expertise in gut-brain axis biology, metabolism and the microbiome to develop innovative therapeutics designed to improve patients’ lives. Bloom’s clinical programs include BL-001, a first-in-class, orally delivered, Live Biotherapeutic Product (LBP) designed to replicate the therapeutic effects of the Ketogenic Diet. Bloom’s proprietary discovery platform, IrisRx™ enables a fundamentally different approach to developing medicines by harnessing our expanding insight into the Gut-Brain Axis to design and develop therapeutics that target novel biology with superior safety profiles. Bloom Science is advancing a deep pipeline of programs, focused in Obesity, Dravet syndrome and DEEs, Amyotrophic Lateral Sclerosis (ALS), and other neurodegenerative and cognitive disorders.

       

       

       

       

       

      Bloom Science Granted Multiple New US and EU Patents Strengthening its IP Portfolio

      SAN DIEGO, Calif., January 31, 2024 —Bloom Science, Inc., today announced that the United States Patent and Trademark Office (USPTO) and European Patent Office have issued multiple new patents, US 11,883,441 and EP 3558329 (covering 18 countries). The new patents broadly cover pharmaceutical compositions of bacterial strains and methods of using the bacterial strains for therapeutic products to treat seizures. The newly issued patents are exclusively licensed to Bloom Science under an agreement with the Regents of the University of California and provide coverage through at least 2038. These issuances further strengthen Bloom’s leading intellectual property position in the microbiome field, which includes previous issuances of US 11,129,858, JP7166280, and AU2017382197.

      “The continued expansion of our intellectual property portfolio further demonstrates Bloom’s leading IP position in the fields of neuro-metabolism and gut-brain axis and provides further recognition of the ground-breaking work of Bloom Science’s co-founder Dr. Elaine Hsiao,” said Christopher Reyes, Ph.D., Chief Executive Officer of Bloom Science.

      The new U.S. patent issuances broaden the intellectual property protection coverage for Bloom’s lead drug BL-001 in various epileptic syndrome and other clinical-stage programs.

      About Bloom Science

      Bloom Science is a clinical-stage company, trailblazing a path to transformative, novel therapeutics for patients with rare and complex neurological and metabolic disorders. Bloom’s proprietary discovery platform, IrisRx™ enables a fundamentally different approach to developing medicines by harnessing our expanding insight into the Gut-Brain Axis to design and develop therapeutics that target novel biology with superior safety profiles. The IrisRx™ platform unlocks the potential for developing multi-functional therapeutics from the most common cell type in the human body, gut commensal microbes, while also utilizing an expanding proprietary knowledge base to advance therapeutic candidates based on synthetic biology. Bloom Science is advancing a deep pipeline of programs, including Dravet syndrome, other rare epilepsies, Amyotrophic Lateral Sclerosis (ALS), and neurodegenerative and cardiometabolic disorders. For more information, visit: https://bloomscience.com/

      Forward-Looking Statement

      This press release may contain “forward-looking statements,” including statements by Dr. Reyes or other persons on Bloom Science’s behalf and statements regarding Bloom Science’s expectations about any of the following: (i) the safety, efficacy and clinical progress of our various clinical programs, including our BL-001 program; (ii) the status of clinical trials (including activities at clinical trial sites); (iii) the data generated by ongoing and planned clinical trials, and the ability to use that data for the design and initiation of further clinical trials; and (iv) the therapeutic value, development, and commercial potential of Bloom Science Live Biotherapeutic Products. The words “believes,” “anticipates,” “plans,” “expects” and similar expressions are intended to identify forward-looking statements. You are cautioned that forward-looking statements are inherently uncertain. Although Bloom Science believes such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, forward-looking statements are neither promises nor guarantees and are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially.  You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Bloom Science disclaims any obligation or undertaking to update or revise any forward-looking statements, other than as required by law.

       

      Bloom Science to Present at the 7th Annual Sachs Neuroscience Innovation Forum

      SAN DIEGO, Calif., January 2, 2024 – Bloom Science, Inc., today announced that Christopher Reyes, Ph.D., Chief Executive Officer of Bloom Science, will be presenting at the 7th Annual Sachs Neuroscience Innovation Forum being held January 7, 2024 at the Marines’ Memorial Club in San Francisco, CA. This

      7th Annual Neuroscience Innovation Forum
      Date: Sunday, January 7, 2024
      Time: 12:15 p.m. PT

      About Bloom Science

      Bloom Science is a clinical-stage company, trailblazing a path to transformative, novel therapeutics for patients with rare and complex neurological and metabolic disorders. Bloom’s proprietary discovery platform, IrisRx™ enables a fundamentally different approach to developing medicines by harnessing our expanding insight into the Gut-Brain Axis to design and develop therapeutics that target novel biology with superior safety profiles. The IrisRx™ platform unlocks the potential for developing multi-functional therapeutics from the most common cell type in the human body, gut commensal microbes, while also utilizing an expanding proprietary knowledge base to advance therapeutic candidates based on synthetic biology. Bloom Science is advancing a deep pipeline of programs, including Dravet syndrome, other rare epilepsies, Amyotrophic Lateral Sclerosis (ALS), and neurodegenerative and cardiometabolic disorders. For more information, visit: https://bloomscience.com/

       

       

      Bloom Science Announces Positive Topline Data from a Phase 1 Clinical Trial of BL-001, a Potential First-in-Class Therapeutic Being Developed for Both Dravet Syndrome and ALS

      SAN DIEGO, August 17 2023 –

       

        • BL-001 demonstrated a favorable safety and tolerability profile in healthy volunteers that supports dosing up to 10-fold higher than the efficacious dose level in animal models

        • Dose dependent strain kinetics of BL-001 observed

        • The U.S. Food and Drug Administration (FDA) grants Rare Pediatric Disease Designation to BL-001 for Dravet syndrome

      Bloom Science, Inc., a clinical-stage, central nervous system (CNS) company focused on discovering and developing breakthrough therapeutics that target the Gut-Brain Axis for neurological diseases, today announced positive results from its Phase 1 clinical study in healthy volunteers that demonstrate a favorable safety, tolerability and strain kinetics profile of BL-001, an orally-delivered Live Biotherapeutic Product (LBP). Bloom is developing BL-001 for both Dravet syndrome and amyotrophic lateral sclerosis (ALS). Bloom also announced today that BL-001 received Rare Pediatric Disease Designation from FDA for Dravet syndrome.

      “Dravet syndrome is a rare and devastating form of childhood epilepsy in which there is an unmet need for patients whose seizures remain difficult to control and who experience significant side effects with current medications,” said Paolo Baroldi, PhD, MD, Chief Medical Officer of Bloom Science. “BL-001 shows promise as a novel treatment option that can change lives. With these results we plan to proceed into Phase 2 clinical development with doses we expect to be within the therapeutic window in both Dravet syndrome and ALS.”

      Summary of Key BL-001 Phase 1 Study Results:

       

        • BL-001 demonstrated a favorable safety profile and was well tolerated with no Serious Adverse Events (SAEs) across all four dose cohorts 

        • Favorable strain kinetics were observed with BL-001 component strains increasing in a dose dependent manner

        • All treatment-related Adverse Events (AEs) were mild with the exception of one subject in the highest dose who experienced moderate fatigue that resolved without intervention and they continued on treatment 

        • In the highest dose cohort of BL-001, the most common treatment-related adverse event (AE) was decreased appetite (3/6 subjects) with no other treatment-related AEs occurring in more than a single individual

        • All treatment-related AEs were transient, with the exception of decreased appetite which persisted until the follow-up period for two subjects, and all treatment-related AEs resolved without intervention

        • No AEs led to study drug withdrawal and all participants completed the study

        • There were no clinically significant ECG abnormalities reported in any individual across all treatment cohorts

      “By taking a breakthrough approach to therapeutic development via the Gut-Brain Axis, we believe Bloom has the potential to develop completely novel, transformational treatments with superior safety and efficacy profiles that can have a significant impact on the lives of the patients suffering from rare diseases,” said Christopher Reyes, PhD, founder and CEO of Bloom Science.  “This milestone builds on many years of groundbreaking work that validate Bloom’s IrisRx platform and ability to select strains optimized for both safety and activity.”

      Based on the preclinical profile together with these Phase 1 results, Bloom intends to advance BL-001 into Phase 2 studies in both Dravet syndrome and ALS patients in 2024.

      About Phase 1 Clinical Trial of BL-001 in Healthy Volunteers
      The Phase 1 study of BL-001 was a randomized, double-blind, placebo-controlled, single-center, multiple ascending dose study in healthy volunteers (NCT05818306). The primary objective of the study was to investigate the safety and tolerability of BL-001 in healthy volunteers for 28 consecutive days. In the study, BL-001 or placebo was administered to 32 healthy adult participants (BL-001 n=24; placebo n =8) across four dose cohorts.

      About BL-001
      BL-001 is a first-in-class, orally delivered, Live Biotherapeutic Product (LBP) being developed by Bloom Science for the treatment of multiple neurological diseases, including Dravet syndrome and ALS.

      BL-001 was first designed to replicate the antiepileptic effect of the Ketogenic Diet to modulate gamma aminobutyric acid (GABA) and other key bioenergetic pathways. BL-001 contains two rationally selected human gut microbes that have been shown in both cell-based assays and animal studies to eliminate hyper-excitatory activity, increase GABA in the hippocampus and significantly reduce or eliminate both seizure frequency and duration.

      BL-001 also aims to address the underlying oxidative stress, a critical factor in the progression of ALS, to potentially slow or halt disease progression. BL-001 has been shown to attenuate motor-neuron loss, increase lifespan and motor coordination in preclinical ALS studies.

      About Bloom Science
      Bloom Science is a clinical-stage, central nervous system (CNS) company, trailblazing a path to transformative, novel therapeutics for patients with rare and complex neurological disorders. Bloom’s proprietary discovery platform, IrisRx™ enables a fundamentally different approach to developing medicines by harnessing our expanding insight into the Gut-Brain Axis to design and develop therapeutics that target novel biology with superior safety profiles. The IrisRx™ platform unlocks the potential for developing multi-functional therapeutics from the most common cell type in the human body, gut commensal microbes, while also utilizing an expanding proprietary knowledge base to advance therapeutic candidates based on synthetic biology. Bloom Science is advancing a deep pipeline of programs, including Dravet syndrome, other rare epilepsies, Amyotrophic Lateral Sclerosis (ALS), and other neurodegenerative and cognitive disorders. For more information, visit: https://bloomscience.com/

      Forward-Looking Statement
      This press release may contain “forward-looking statements,” including statements by Dr. Reyes or other persons on Bloom Science’s behalf and statements regarding Bloom Science’s expectations about any of the following: (i) the safety, efficacy and clinical progress of our various clinical programs, including our BL-001 program; (ii) the status of clinical trials (including activities at clinical trial sites); (iii) the data generated by ongoing and planned clinical trials, and the ability to use that data for the design and initiation of further clinical trials; and (iv) the therapeutic value, development, and commercial potential of Bloom Science Live Biotherapeutic Products. The words “believes,” “anticipates,” “plans,” “expects” and similar expressions are intended to identify forward-looking statements. You are cautioned that forward-looking statements are inherently uncertain. Although Bloom Science believes such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, forward-looking statements are neither promises nor guarantees and are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially.  You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Bloom Science disclaims any obligation or undertaking to update or revise any forward-looking statements, other than as required by law.

       

       

      Bloom Science Names Top Biotechnology Executive, Dr. Grace E. Colón, Board Chair

      SAN DIEGO, May 17, 2023 – Bloom Science, Inc., a clinical-stage, central nervous system (CNS) company focused on discovering and developing breakthrough therapeutics that target the Gut-Brain Axis, today announced the appointment of Dr. Grace E. Colón as Chair of its Board of Directors, effectively immediately. A distinguished scientist and leading executive in biotechnology, Dr. Colón will lend her business, scientific, clinical and operational expertise towards helping Bloom Science in an exciting stage of research and development of new diagnostics and transformative medicines for patients with complex neurological disorders.

      Dr. Colón has over 25 years of experience in biopharma, genomics, diagnostics, healthcare, industrial microbiology/biotechnology, synthetic biology, venture capital, management consulting, and entrepreneurship. Most recently, she was CEO and President of InCarda Therapeutics from 2013 to 2022, where she led the company from a seed stage start-up to one with a best-in-class inhaled cardiovascular disease therapy being evaluated in a pivotal Phase 3 trial and a growing pipeline. She serves on the boards of CareDx, Voyager Therapeutics, the MIT Corporation (MIT’s Board of Trustees) and the Biotechnology Innovation Organization (BIO), and is also Executive Chair (formerly CEO) of ProterixBio. Formerly, Dr. Colón held senior executive roles at Intrexon Corporation, Gilead Sciences, and Affymetrix. She was a partner at New Science Ventures, a New York based venture capital firm, and served on the boards of Paradigm Diagnostics (acquired by Exact Sciences), PerceptiMed and Cocoon Biotech and on the Advisory Board of the Miller Center for Social Entrepreneurship at Santa Clara University. Earlier in her career, Dr. Colón was a management consultant at McKinsey & Company and an engineer at Merck. She received her Ph.D. in chemical engineering from the Massachusetts Institute of Technology, where she was a National Science Foundation Fellow. She also holds an undergraduate degree in chemical engineering from the University of Pennsylvania.

      “We are thrilled to welcome Dr. Colón as the Chair of our Board of Directors,” said Christopher Reyes, PhD, founder and CEO of Bloom Science. “Dr. Colón’s extensive technical and leadership expertise in biotech, including building strategic partnerships and fundraising, will help Bloom Science achieve our mission to deliver transformative, holistic therapeutics that have the potential to treat multiple comorbidities and that can result in fewer side effects compared to other drugs currently on the market for patients with neurological diseases.”

      “Bloom Science is the leading microbiome company dedicated to developing innovative therapies for neurological diseases through the gut-brain connection,” said Dr. Colón. “Bloom’s uniquely rigorous and engineering-based approach to developing microbiome-based therapeutics, along with the company’s highly experienced team and exceptional board of directors, strongly positions the company to have a significant positive impact on patients who have not adequately responded to existing CNS and other therapies. I am honored to have the opportunity to support this vital and exciting work.”

      About Bloom Science

      Bloom Science is a clinical-stage, central nervous system (CNS) company, trailblazing a path to transformative, novel therapeutics for patients with rare and complex neurological disorders. Bloom’s proprietary discovery platform, IrisRx™ enables a fundamentally different approach to developing medicines by harnessing our expanding insight into the Gut-Brain Axis to design and develop therapeutics that target novel biology with superior safety profiles. The IrisRx™ platform unlocks the potential for developing multi-functional therapeutics from the most common cell type in the human body, gut commensal microbes, while also utilizing an expanding proprietary knowledge base to advance therapeutic candidates based on synthetic biology. Bloom Science is advancing a deep pipeline of programs, including Dravet syndrome, other rare epilepsies, Amyotrophic Lateral Sclerosis (ALS), and other neurodegenerative and cognitive disorders. For more information, visit: https://bloomscience.com/

      Bloom Science Completes Enrollment in Phase 1 Trial of BL-001, a First-in-Class Therapy Being Developed for Dravet Syndrome

      BL-001 Designed to Replicate the Antiepileptic Effects of the Ketogenic Diet

      Topline Results including Safety and Tolerability Expected in Third Quarter of 2023

      SAN DIEGO, April 25, 2023 – Bloom Science, Inc., a clinical-stage, central nervous system (CNS) company focused on discovering and developing breakthrough therapeutics that target the Gut-Brain Axis, today announced that the company has completed enrollment in all four cohorts of healthy adult participants as part of its Phase 1 clinical trial. Bloom is developing BL-001 for Dravet syndrome, a rare pediatric epilepsy that significantly impacts individuals throughout their lifetime.

      “The initial dosing and completion of enrollment of our Phase 1 clinical trial for BL-001 represents a huge milestone for Bloom Science and for the epilepsy community as we advance our clinical development program for Dravet syndrome and other developmental epilepsies,” said Christopher Reyes, PhD, founder and CEO of Bloom Science. “We believe BL-001 has the potential to provide patients with the same neurological and seizure relief benefits of the Ketogenic Diet, but in the form of a simple daily oral therapeutic. Our preclinical studies have shown that BL-001 possesses strong potential to reduce neuronal hyperexcitability, control seizures and overcome drug-resistance with significantly fewer side effects compared to other drugs on the market. We are committed to developing a more holistic therapy for patients with Dravet syndrome that not only reduces seizure burden, but also treats significant comorbidities.”

      Bloom’s BL-001 is an orally administered Live Biotherapeutic Product reverse translated from the positive clinical outcomes associated with the Ketogenic Diet in treating refractory epilepsy. The Phase 1 study of BL-001 is a randomized, double-blind, placebo-controlled, single-center, multiple ascending dose study in healthy volunteers. The primary objective of this study is to evaluate the safety and tolerability of BL-001. A total of 32 healthy adult volunteers have been enrolled, across four dose cohorts and randomized in a 3 to 1 ratio of BL-001 to placebo. The trial will also evaluate the effects of BL-001 on the gut microbiota and pharmacodynamic biomarkers.

      The Phase 1 trial is being conducted in Europe. Following successful completion of the Phase 1 trial, Bloom intends to initiate a Phase 2 study in patients with Dravet syndrome.

      More information about the Phase 1 trial is available at clinicaltrials.gov (NCT05818306).

      About Dravet Syndrome
      Dravet syndrome, a rare and devastating treatment-resistant form of childhood epilepsy, presents significant unmet needs for patients. Patients typically try many different medications, sometimes experiencing significant side effects, yet seizures remain difficult to control and are not well managed with current medications. Dravet syndrome is characterized by intractable seizures and significant developmental delays. The onset of seizures is usually between five and eight months of age, after previous normal development. Dravet syndrome affects nearly every aspect of patients’ and their families’ lives. Ten to twenty percent of individuals with the condition do not survive beyond the age of ten. Beyond medication, the ketogenic diet is also used to treat Dravet syndrome.

      About BL-001
      BL-001 is a first-in-class, orally delivered, Live Biotherapeutic Product (LBP) being developed by Bloom Science for the potential treatment of seizures associated with Dravet syndrome and other rare developmental and epileptic encephalopathies (DEEs). BL-001 is designed to replicate the antiepileptic effect of the Ketogenic Diet to modulate gamma aminobutyric acid (GABA) and other key bioenergetic pathways to suppress hyperexcitability which is a key driver in seizures. BL-001 contains two rationally selected human gut microbes that have been shown in both cell-based assays and animal studies to eliminate hyper-excitatory activity, increase GABA in the hippocampus and significantly reduce or eliminate both seizure frequency and duration.

      About Bloom Science
      Bloom Science is a clinical-stage, central nervous system (CNS) company, trailblazing a path to transformative, novel therapeutics for patients with rare and complex neurological disorders. Bloom’s proprietary discovery platform, IrisRx™ enables a fundamentally different approach to developing medicines by harnessing our expanding insight into the Gut-Brain Axis to design and develop therapeutics that target novel biology with superior safety profiles. The IrisRx™ platform unlocks the potential for developing multi-functional therapeutics from the most common cell type in the human body, gut commensal microbes, while also utilizing an expanding proprietary knowledge base to advance therapeutic candidates based on synthetic biology. Bloom Science is advancing a deep pipeline of programs, including Dravet syndrome, other rare epilepsies, Amyotrophic Lateral Sclerosis (ALS), and other neurodegenerative and cognitive disorders.


      Bloom Science Forward-Looking Statement

      This press release may contain a number of “forward-looking statements,” including statements made by Dr. Reyes in this press release, as well as statements regarding Bloom Science’s expectations about any or all of the following: (i) the safety, efficacy and clinical progress of our various clinical programs, including our BL-001 program; (ii) the status of clinical trials (including, without limitation, activities at clinical trial sites) and expectations regarding data from clinical trials; (iii) the data that will be generated by ongoing and planned clinical trials, and the ability to use that data for the design and initiation of further clinical trials; and (iv) the therapeutic value, development, and commercial potential of Bloom Science Live Biotherapeutic Products, including as compared to other therapies. Without limiting the foregoing, the words “believes,” “anticipates,” “plans,” “expects” and similar expressions are intended to identify forward-looking statements. You are cautioned that forward-looking statements are inherently uncertain. Although Bloom Science believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those projected or suggested in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: the potential for initial and preliminary data from any clinical trial and initial data from a limited number of patients not to be indicative of final trial results; the potential that clinical trial results may not be favorable; potential impacts due to the coronavirus pandemic, such as the timing and progress of clinical trials; that future competitive or other market factors may adversely affect the commercial potential for Bloom Science’s product candidates; uncertainties regarding the intellectual property protection for Bloom Science’s technology and intellectual property belonging to third parties, and the outcome of proceedings (such as an interference, an opposition or a similar proceeding) involving all or any portion of such intellectual property.  You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Bloom Science disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.

       

      Bloom Science to Develop ALS Biotherapeutics with Exclusive Technology License from Yeda, the Technology Transfer Company of Weizmann Institute of Science

      SAN DIEGO, Calif., January 4, 2023 Bloom Science, Inc., a clinical-stage biotechnology company developing novel medicines for neurological diseases and conditions, and Yeda Research and Development Co Ltd, the Weizmann Institute of Science’s technology transfer arm to advance science for the benefit of humanity, have entered into an agreement in which Bloom obtained from Yeda an exclusive, worldwide license to use specific microbial strains in developing and commercializing live biotherapeutic products (LBPs) to ameliorate amyotrophic lateral sclerosis (ALS) symptoms. 

      There is a large unmet need for patients who have not responded to existing therapies for ALS, a disease that causes nerve cells to die, which breaks the neural pathways, and causes extreme mobility loss over time. Bloom’s systematic approach to developing a new generation of therapeutics starts with the gut microbiome. 

      “The gut microbiome’s influence on the brain offers incredible potential for healing,” said Bloom Science founder and CEO Christopher Reyes, PhD. “Bloom’s collaboration with Yeda enables us to advance our program to modulate the gut microbiome interaction with the brain and provide ALS patients with new therapeutic options that help restore brain function.”

      Bloom’s final lead orally-administered LBP candidate selection for ALS, BL-002, started in 2022 with animal models and will advance towards human clinical trials in 2023. The company is testing multiple drug candidates for ALS.

      Bloom’s BL-002 is built on evidence that oxidative stress drives ALS by causing the loss of motor neurons and the dysfunction of mitochondria. Nicotinamide, an important NAD+ pathway metabolite and a derivative of vitamin B3, can counter the effects of ALS.

      BL-002 produces this vitamin and Bloom has shown it attenuates motor-neuron loss, and increases lifespan and motor coordination, in ALS model mice.

      ABOUT BLOOM SCIENCE

      Bloom Science is a clinical-stage biotechnology company on a mission to bring transformative live biotherapeutic products (LBPs) to underserved patients with rare or complex neurological diseases who have not adequately responded to existing therapies. Bloom is taking a fundamentally different path to developing medicines by harnessing our expanding insight into how the gut microbiome modulates key processes in the immune system, nervous system and brain. Bloom has developed a platform to investigate how changes in the gut microbiome influence brain biochemistry and immune system activity that it can leverage to develop multi-functional therapeutics addressing multi-pathway driven neurological disorders. Learn more: https://bloomscience.com/