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

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

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

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 to Present at Connecting Microbiome Communities Conference

    Bloom Science to Present at Connecting Microbiome Communities Conference

     

    SAN DIEGO, Calif., November 1, 2024 – Bloom Science, Inc., a clinical-stage biotech company focused on the development of novel therapies for metabolic and neurological disorders, today announced that Sr. Scientist Lisa Elmén, Ph.D., will be presenting at the Connecting Microbiome Communities Conference being held November 3-6, 2024 in San Diego, CA.

    Details are as follows:

    • Connecting Microbiome Communities Conference
      Details: Dr. Elmén will deliver a scientific presentation titled: IrisRx: A Drug Discovery Platform to Develop Microbiota-based Therapeutics Targeting the Gut-Brain Axis
      Conference dates: November 3-6, 2024
      Presentation Timing: 1:15am PST on November 6, 2024

    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 24th Annual Biotech in Europe Forum

    Bloom Science to Present at 24th Annual Biotech in Europe Forum

     

    SAN DIEGO, Calif., September 24, 2024 – 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 be presenting at the 24th Annual Biotech in Europe Forum being held September 25-26, 2024 in Basel Switzerland.

    Details are as follows:

    • 24rd Annual Biotech in Europe Forum
      Details: Dr. Reyes will deliver a corporate presentation and participate in 1-on-1 meetings
      Conference dates: September 25-26, 2024
      Presentation Timing: 14:05 CEST on September 25, 2024

    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.

    Christopher Reyes, Founder and CEO of Bloom Science, joins a panel of experts to explore the Science of the Gut-Brain Axis

    Christopher Reyes, Founder and CEO of Bloom Science, joins a panel of experts to explore the Science of the Gut-Brain Axis 

    SAN DIEGO, Calif., August 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 CEO Christopher Reyes will join a panel of entrepreneurs and researchers as they discuss the complexities of the gut microbiome and its profound impact on mental health and overall well-being.

    Gut Feelings: Exploring the Gut-Brain Connection Lecture
    Tue, Aug 6; 6:30P – 8:00P
    The Battery SF

    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.

    Bloom Science to Participate at Upcoming Patient Advocacy Conferences

    Bloom Science to Participate at Upcoming Patient Advocacy Conferences

     

    SAN DIEGO, Calif., June 20, 2024 — Bloom Science, Inc., a clinical-stage biotech company focused on the development of novel therapies for metabolic and neurological disorders, today announced that the company will participate in two upcoming patient advocacy conferences.

    2024 Dravet Syndrome Foundation Conference in Minneapolis
    Date: June 20-22, 2024
    Location: Minneapolis

     

    ALS Nexus 2024
    Date: July 14 – 17, 2024
    Location: Dallas

    Poster Presentation: Development of BL-001 for the Treatment of ALS through Multiple Gut-Brain Mediated Pathways. PResenter: Christopher Reyes, PhD

     

    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.

    Bloom CEO Christopher Reyes, PhD Patriciates on IamBIO podcast Focused on Exploring the Science of the Microbiome

    Bloom CEO Christopher Reyes, PhD Patriciates on IamBIO podcast Focused on Exploring the Science of the Microbiome

    SAN DIEGO, Calif., March 12, 2024 —The gut microbiome plays a crucial role in our health. However, there is still much to learn about this complex ecosystem. In today’s IamBIO episode, Bloom’s CEO Chris Reyes joins other experts who tell us where the science is—how much we know, and how much we don’t.

    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.

    Bloom Science to Present at the Biocom Global Partnering & Investor Conference

    Bloom Science to Present at the Biocom Global Partnering & Investor Conference

     

    SAN DIEGO, Calif., February 20, 2024 — Bloom Science, Inc., today announced that Christopher Reyes, Ph.D., Chief Executive Officer of Bloom Science, will be presenting at the Biocom Global Partnering & Investor Conference being held February 27-29, 2024 at the Lodge at Torrey Pines in La Jolla, CA.

    Biocom Global Partnering & Investor Conference
    Date: Wednesday, February 28, 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 Granted Multiple New US and EU Patents Strengthening its IP Portfolio

    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

    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

    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

     

      • 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

    SAN DIEGO, August 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 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.