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

by | Mar 23, 2026 | Press Releases

  • 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 to Participate in Keystone Symposia on Obesity Therapeutics and Microbiome Revolution Symposium

by | Jan 23, 2026 | In the News

SAN DIEGO, Calif., January 23, 2026 – Bloom Science, Inc., a clinical-stage biotechnology company developing next-generation live biotherapeutic medicines targeting the gut-brain axis, today announced that members of its executive leadership team will participate in the upcoming Keystone Symposia on Obesity Therapeutics and the Microbiome Revolution Symposium hosted by CE-Ventures in Dubai.

These scientific engagements will provide Bloom an opportunity to share its differentiated approach to metabolic and neurological disease, centered on microbiome-driven modulation of the gut-brain axis.

At the Keystone Symposia on Obesity Therapeutics, Bloom plans to engage with leading academic researchers, clinicians, and biotechnology innovators to discuss emerging advances in obesity biology and translational medicine. The company intends to highlight its lead clinical-stage program, BL-001, an orally delivered live biotherapeutic product designed to replicate key therapeutic mechanisms of ketogenic biology through gut-derived metabolic signaling.

“Obesity is a complex, multi-pathway disease that requires innovative therapeutic strategies,” said Christopher Reyes, PhD, Chief Executive Officer of Bloom Science. “We look forward to engaging with leaders in metabolic science and discussing how our live biotherapeutic approach may offer a differentiated path forward.”

At the Microbiome Revolution Symposium in Dubai, Dr. Reyes is scheduled to present Bloom’s platform strategy and clinical progress to an international audience of microbiome researchers, healthcare investors, and industry leaders. The symposium will focus on the growing role of microbiome science in transforming therapeutic development.

Bloom intends to showcase its proprietary IrisRx™ discovery platform and discuss how its programs are designed to influence systemic metabolism and neurological function through the gut-brain axis. The company will also provide updates on BL-001, which demonstrated statistically significant placebo-adjusted weight loss and durable metabolic effects in a Phase 1 clinical trial and is advancing toward Phase 2 development in obesity and rare epilepsies, including Dravet syndrome.

“These forums represent important opportunities to connect with the global scientific and investment communities,” added Dr. Reyes. “We believe microbiome-driven therapeutics are poised to redefine treatment paradigms across metabolic and neurological disease.”

Bloom management will be available for meetings during both events.

About Bloom Science
Bloom Science is a clinical-stage biotechnology company developing live biotherapeutic medicines targeting the gut-brain axis. Powered by its proprietary IrisRx™ discovery platform, Bloom designs therapeutics that modulate metabolic and neurological pathways to address complex diseases including obesity and rare epilepsies. Bloom is headquartered in San Diego, California.

 

 

 

 

 

 

 

 

 

Bloom Science to Participate in J.P. Morgan Healthcare Conference and Sachs Neuroscience Innovation Forum

by | Jan 8, 2026 | In the News

SAN DIEGO, Calif., January 8, 2026 – Bloom Science, Inc., a clinical-stage biotechnology company developing next-generation live biotherapeutic medicines targeting the gut-brain axis, today announced that members of its executive leadership team will participate in the 44th Annual J.P. Morgan Healthcare Conference in San Francisco and the upcoming 9th Annual Sachs Neuroscience Innovation Forum.

Bloom’s leadership team will meet with investors, strategic partners, and industry leaders during J.P. Morgan Healthcare Conference week, and will engage with neuroscience-focused investors and innovators at the Sachs Neuroscience Innovation Forum, which convenes global stakeholders advancing therapies for neurological and neurodegenerative disorders.

At these meetings, Bloom intends to highlight recent clinical progress from its lead program, BL-001, an orally delivered live biotherapeutic product designed to replicate key mechanisms of ketogenic biology. Phase 1 data demonstrated statistically significant placebo-adjusted weight loss and durable metabolic effects, supporting the program’s advancement toward Phase 2 development in obesity and rare epilepsies, including Dravet syndrome.

“Healthcare Conference week provides an important opportunity to engage both the broader investment community and specialized neuroscience investors,” said Christopher Reyes, PhD, Chief Executive Officer of Bloom Science. “We look forward to discussing our differentiated gut-brain axis approach and our plans to advance BL-001 into its next stage of clinical development.”

The Sachs Neuroscience Innovation Forum brings together leading companies, investors, and academic experts focused on advancing therapies across neurological diseases, including epilepsy, neurodegeneration, and psychiatric disorders. Bloom’s participation reflects its commitment to addressing complex metabolic and neurological conditions through a novel live biotherapeutic modality.

Bloom management will be available for scheduled one-on-one meetings during both conferences.

About Bloom Science
Bloom Science is a clinical-stage biotechnology company developing live biotherapeutic medicines targeting the gut-brain axis. Powered by its proprietary IrisRx™ discovery platform, Bloom designs therapeutics that modulate metabolic and neurological pathways to address complex diseases including obesity and rare epilepsies. Bloom is headquartered in San Diego, California.

 

 

 

 

 

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

by | Mar 4, 2025 | Press Releases

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