- 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.
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