Biomea Fusion Reports Phase 1 Weight Loss Data for Oral GLP-1 Candidate BMF-650
Biomea Fusion, Inc. (BMEA) released preliminary Phase 1 trial results for BMF-650, an experimental oral GLP-1 receptor agonist. Patients in outpatient cohorts achieved a mean weight reduction between 1.5% and 3.2% at Day 29, compared to 0.1% for placebo. In a confined cohort given rapid dose titration from 200 mg to 400 mg, average weight loss reached 6.1%.
The four-week safety study involving 40 patients across multiple ascending dose cohorts showed no severe adverse events. Gastrointestinal side effects were mostly mild to moderate with low overall occurrence rates. These initial findings could support a potential no-titration dosing schedule, which could improve patient adherence compared to existing treatments.
Biomea Fusion is seeking a strategic partner to assist with late-stage development and commercialization. Investors will watch for Phase 2 trials to evaluate whether the drug maintains its efficacy and safety profile over longer durations. Shares of Biomea Fusion fell 7.35% to $1.26 following the report.
Key points
- Biomea Fusion, Inc. (BMEA) reported 1.5% to 3.2% mean weight loss at Day 29 in outpatient Phase 1 cohorts compared to 0.1% for placebo.
- A confined trial cohort achieved 6.1% weight loss following rapid dose titration from 200 mg to 400 mg.
- The trial recorded no severe adverse events across 40 patients, with gastrointestinal side effects remaining mostly mild to moderate.
- The company is searching for a strategic partner to support late-stage development and commercialization.
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What were the Phase 1 trial results for Biomea Fusion BMF-650?
Patients taking BMF-650 in outpatient cohorts saw average Day-29 weight loss of 1.5% to 3.2% versus 0.1% for placebo, while a confined cohort achieved 6.1% weight loss.
What side effects were reported in the BMF-650 trial?
No severe adverse events occurred among 40 patients in multiple ascending dose cohorts. Gastrointestinal side effects were primarily mild to moderate with low overall rates.
Is Biomea Fusion looking for a partner for BMF-650?
Yes, Biomea Fusion is seeking a strategic partner to fund and assist with late-stage development and commercialization of BMF-650.
