Bloom Science’s trial examining its primary pipeline weight loss drug, designed to replicate the positive effects of the ketogenic diet, has seen 80% of patients sustaining weight loss for two weeks after the last dose.
The San Diego-based company has announced that final data from its randomised, double-blind, placebo-controlled Phase I trial (NCT05818306) showed that patients dosed with the company’s orally administered live biotherapeutic, BL-001, achieved a statistically significant amount of weight loss over placebo.
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The safety and efficacy study recruited 32 adults ranging in body weight from healthy weight to overweight.
Patients dosed with BL-001 saw a 2.3% drop in body weight compared with placebo. Additionally, overweight patients benefited from a 2.2% drop compared with healthy-weight patients who also received the study drug.
Of the 80% of patients who were able to maintain weight loss for at least two weeks following dosing, 100% of these patients saw weight loss of 3.4% on average by the end of the two-week follow-up period.
Louis Licamele, chief development officer at Bloom Science, said: “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.
“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.”
Currently, the weight loss market is dominated by small molecule glucagon-like peptide 1 receptor agonist (GLP-1RA) therapies such as Novo Nordisk’s Wegovy (semaglutide) and Eli Lili’s Zepbound (tirzepatide), with research by GlobalData estimating both drugs will bring in approximately $16bn and $11bn by the end of 2025 respectively.
One potential drawback however, according to research published in the journal, Evidence-Based Practice, found that GLP-1RA drugs are typically unable to maintain patient weight loss once dosing has stopped, leading to patients potentially regaining weight.
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Now, Bloom Science has said it plans to study BL-001 for the treatment of Dravet syndrome and amyotrophic lateral sclerosis (ALS) as well as other developmental and epileptic encephalopathies. It also plans to move ahead to a Phase II trial examining its weight loss therapy in an obese population.
Christopher Reyes, CEO of Bloom Science, said: “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. This validation supports our continued clinical efforts targeting both obesity and Dravet syndrome.”
The news comes as the industry marks World Obesity Care Week. Elsewhere in the field, Ascletis Pharma’s once daily oral small molecule GLP-1RA has demonstrated a 6.3% cut in body weight after 28 days in a Phase Ib trial. Meanwhile, Novo Nordisk is planning a new Phase III trial for CagriSema, the company’s next-generation obesity drug touted as a potential successor to Wegovy.
