Biomea Fusion reports Phase 1 topline data for oral GLP-1 candidate BMF-650
On October 13, 2026, the company disclosed MAD and confinement-cohort results from the GLP-131 study, showing weight loss up to 6.1% and no serious treatment-related adverse events.
Biomea Fusion, Inc. hosted a conference call on October 13, 2026, to discuss topline results from its ongoing Phase 1 GLP-131 trial of BMF-650, an investigational next-generation oral small molecule GLP-1 receptor agonist1, according to an 8-K filed the same day.
The GLP-131 study is a randomized, double-blind, placebo-controlled trial evaluating safety, tolerability, and weight reduction with BMF-650 in overweight or obese participants, using multiple ascending dose and single ascending dose designs1. In the initial four-cohort analysis, mean percentage change in body weight from baseline at Day 29 ranged from -1.5% in Cohort 1 to -3.2% in Cohort 3, versus -0.1% for pooled placebo1.
A fifth cohort was added after PK results from Week 1 in Cohort 4 raised suspicion that patients were possibly not taking the drug, so a Cohort 5 was initiated under confinement1. In that cohort, participants received 200 mg once daily for one week, then 400 mg once daily for three weeks, reaching a total weight loss of 6.20 kg, with mean weight loss of 1.55 kg per week, compared with similar weight loss in the two placebo participants1.
On safety, the company reported that all treatment-emergent adverse events were mild or moderate, with no dose modifications or study discontinuations related to BMF-650, and TEAEs were not associated with dose escalation, dosing cohort, or time at a given dose1. Gastrointestinal events were limited, with select GI-related TEAEs all classified as Grade 1 in the highest dose level cohort1.
The company said the findings reached the target dose of 400 mg QD via a single titration step post week 1, supporting a potentially simple and practical dosing paradigm1, and that Cohort 5 showed sustained weight loss at 400 mg across consecutive weeks, reaching 6.1% weight reduction at week 4, with no evidence of attenuation over the treatment period1. Biomea Fusion said next steps include initiating longer-term toxicology studies to support Phase 2 dosing and advancing Phase 2 development planning, including a "no-titration" regimen at 400 mg QD1.
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