Biomea Fusion Announces Phase 1 Results for BMF-650, its Investigational Next-Generation Oral Small Molecule GLP-1 Receptor Agonist
Key Highlights
- ➤BMF-650 cut mean weight 1.5%-3.2% by Day 29 across Cohorts 1-4
- ➤Cohort 5 achieved 6.1% mean weight reduction at Day 29
- ➤400 mg QD one-step titration was well tolerated; all TEAEs were mild
- ➤No severe or serious TEAEs, dose modifications, or discontinuations occurred
- ➤Biomea plans longer-term toxicology work while seeking a strategic partnership
Expert Statements
Mick Hitchcock, Interim Chief Executive Officer and Board Member of Biomea Fusion
“BMF-650 is the culmination of a program we initiated approximately four years ago, and these Phase 1 results provide important clinical validation of the work behind its design”
Mick Hitchcock, Interim Chief Executive Officer and Board Member of Biomea Fusion
“We observed consistent weight reduction across multiple dose cohorts, encouraging tolerability and the ability to reach 400 mg after just one brief titration step.”
Mick Hitchcock, Interim Chief Executive Officer and Board Member of Biomea Fusion
“We believe these findings warrant further evaluation, including through potential collaborations.”
Mick Hitchcock, Interim Chief Executive Officer and Board Member of Biomea Fusion
“At the same time, our primary development focus remains firmly on menin inhibition with icovamenib in type 1 and type 2 diabetes, where we have several important clinical milestones ahead.”
Thorsten Kirschberg, Executive Vice President of Research at Biomea Fusion and program lead for BMF-650
“Our objective in designing BMF-650 was not to maximize weight loss compared to other oral GLP-1s, but rather we specifically designed the molecule for less acute GLP-1 receptor agonism in the GI tract, with the goal of improving GI tolerability while maintaining weight loss consistent with industry standards weight loss.”
Thorsten Kirschberg, Executive Vice President of Research at Biomea Fusion and program lead for BMF-650
“Our goal was to eliminate titration steps which can take 5 months or more with other GLP-1s and are typically required to avoid over-agonism.”
Thorsten Kirschberg, Executive Vice President of Research at Biomea Fusion and program lead for BMF-650
“BMF-650 was designed to ultimately increase persistence with chronic therapy”
Thorsten Kirschberg, Executive Vice President of Research at Biomea Fusion and program lead for BMF-650
“BMF-650 demonstrated good oral absorption in this study with consistent and sustained systemic exposure.”
Thorsten Kirschberg, Executive Vice President of Research at Biomea Fusion and program lead for BMF-650
“We believe these Phase 1 results provide initial clinical evidence supporting our design strategy, with meaningful weight reduction, a well-tolerated safety profile, and rapid one-step titration to the 400 mg target dose without increasing local GI agonism and side effects.”
* Mean weight reduction ranged from 1.5% to 3.2% at Day 29 across Cohorts 1-4, compared with 0.1% for pooled placebo. * No severe or serious TEAEs, no TEAE-related dose modifications, and no TEAE-related discontinuations among all BMF-650-treated MAD participants. * A rapid one-step titration to the target dose of 400 mg QD in Cohort 5 was equally well tolerated with all TEAEs being mild, with nausea and vomiting each reported in only 12.5% of participants, supporting further evaluation of “no titration” dosing for patients. * Company to host conference call on October 13 at 4:30 p.m. ET (1:30 p.m. PT). SAN CARLOS, Calif., Oct. 13, 2026 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or the “Company”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company, today announced Phase 1 GLP-131 clinical trial results for BMF-650, its investigational oral small-molecule glucagon-like peptide-1 receptor agonist (“GLP-1 RA”), which demonstrated consistent weight reduction across five multiple ascending dose (“MAD”) cohorts over four weeks and encouraging tolerability even when reaching 400 mg QD in the highest dosing cohort after only a single one-week titration step. Together, these findings provide encouraging early evidence of BMF-650’s clinical activity, sustained weight-reduction trajectory, and, importantly, it’s tolerability.
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