Bloom Science, a clinical-stage biotech company pioneering microbiome-based therapies, has announced positive results from its Phase 1 trial of BL-001, an innovative live biotherapeutic product (LBP) designed to replicate the metabolic effects of the ketogenic diet. The trial demonstrated statistically significant weight loss in overweight individuals, with sustained benefits even after treatment cessation, reinforcing BL-001’s potential as a novel multi-pathway solution for obesity and metabolic disorders.
The success of this early-stage study supports Bloom Science’s plans to advance BL-001 into Phase 2 trials targeting both obesity and Dravet Syndrome, a rare developmental and epileptic encephalopathy (DEE). With its dual application in weight management and neurological disorders, BL-001 could emerge as a first-in-class, patient-friendly therapeutic alternative to traditional treatments.
Breakthrough in obesity treatment: significant and sustained weight loss observed
The Phase 1 trial, a randomized, double-blind, placebo-controlled study, evaluated the safety, tolerability, and pharmacokinetics (PK) and pharmacodynamics (PD) of BL-001 over 28 days in 32 healthy and overweight adults.
The results were statistically significant:
- BL-001-treated overweight individuals (BMI ≥ 25) showed a placebo-adjusted mean weight loss of 2.3% (p=0.0007).
- The highest recorded weight loss reached 4.9% over the 28-day period.
- 80% of participants who lost weight during treatment maintained weight loss two weeks after stopping the therapy.
- 100% of overweight individuals in the highest dose group continued losing weight post-treatment, reaching 3.4% total weight loss by the end of the two-week follow-up.
“This is a groundbreaking approach to obesity treatment,” said Louis Licamele, PhD, Chief Development Officer at Bloom Science. “BL-001 addresses key limitations of existing therapies by providing a safer, naturally inspired, and multi-pathway solution that could enhance long-term compliance and patient outcomes.”
Ketogenic-like metabolic effects without the dietary restriction
A key highlight of the study was BL-001’s dose-dependent metabolic impact, which mimicked the ketogenic diet. Participants in the BL-001 treatment group experienced:
- Increased urinary ketones (a hallmark of ketosis).
- Appetite suppression, potentially aiding sustainable weight loss.
- Statistically significant changes in metabolic hormones, including those involved in appetite regulation and digestion.
- Alterations in circulating ketone bodies, further reinforcing its ketogenic-like effects.
These findings suggest that BL-001 could offer the benefits of the ketogenic diet without requiring strict dietary adherence, making it a highly accessible and patient-friendly alternative.
“The ketogenic diet is well-known for its weight loss and therapeutic benefits, but its restrictive nature makes long-term adherence challenging,” said Christopher Reyes, PhD, CEO of Bloom Science. “BL-001 could provide a simpler, daily oral alternative that offers the same metabolic advantages in a sustainable way.”
Beyond weight loss: potential in neurological disorders
The success of BL-001 in inducing ketogenic-like effects holds important implications beyond obesity. The ketogenic diet has long been used as a treatment for Dravet Syndrome and other epileptic disorders, but its stringent dietary demands often make it impractical for patients.
Preclinical studies have demonstrated that BL-001 can:
- Replicate ketogenic diet effects in epilepsy models.
- Modulate GABA (gamma-aminobutyric acid) pathways and other neuroprotective mechanisms.
- Suppress hyperexcitability, a key driver of seizures.
Following this promising Phase 1 data, Bloom Science plans to initiate Phase 2 trials for BL-001 in both obesity and Dravet Syndrome in 2026, reinforcing the drug’s dual application in metabolic and neurological conditions.
A Disruptive new player in the obesity and neurology therapeutics landscape
With current obesity treatments often relying on GLP-1 receptor agonists, such as semaglutide, there is a growing demand for alternative mechanisms with fewer side effects and improved patient adherence. BL-001’s natural, microbiome-based approach could offer a complementary or alternative option to these existing therapies.
The ability of BL-001 to safely induce ketosis and metabolic benefits without dietary restriction positions it as a pioneering candidate in the emerging gut-brain axis approach to obesity and neurological disorders.
“This validation supports our continued clinical efforts in both obesity and Dravet Syndrome,” Reyes emphasized. “We look forward to progressing BL-001 into Phase 2 trials and expanding its therapeutic potential.”
Looking ahead: phase 2 trials and market potential
With Phase 2 trials expected to commence in 2026, Bloom Science is strategically positioning itself to disrupt both the metabolic and neurological therapeutic markets. If successful, BL-001 could redefine obesity treatment while also addressing urgent unmet needs in epilepsy care.
The convergence of microbiome science, metabolism, and neurology is unlocking exciting new therapeutic possibilities, and Bloom Science is at the forefront of this revolution.
