BMF-650 (GLP-131)

October 13, 2026: Biomea Fusion (NASDAQ: BMEA) reported Phase 1 GLP-131 results for oral GLP-1 receptor agonist BMF-650 in overweight or obese otherwise healthy adults. In outpatient multiple ascending dose Cohorts 1-4, mean Day 29 weight reduction ranged from 1.5% to 3.2% versus 0.1% for pooled placebo; at doses of 200 mg QD or higher, mean weekly weight loss was about 0.97 kg.

In a separately interpreted confined Cohort 5, participants received 200 mg QD for one week then 400 mg QD for three weeks. Mean Day 29 weight reduction was 6.1% (6.2 kg), about 1.55 kg/week, but the company said confinement affected eating behavior and noted similar weight reduction in the two placebo patients, who consumed only about 33% of presented food.

Across five active MAD cohorts (n=40), all TEAEs were mild or moderate, with no severe/serious TEAEs, dose modifications, or discontinuations. Across all active cohorts, nausea occurred in 17.5%, vomiting 7.5%, constipation 10%, and diarrhea 5%; no ALT/AST adverse events were reported. In Cohort 5, nausea and vomiting were each 12.5%, constipation 25%, and diarrhea 0%, all Grade 1.

Biomea said longer-term toxicology studies are needed before further BMF-650 development and it is positioning the program for a strategic partnership or licensing deal. Additional data analysis is ongoing for a future medical meeting.