Biomea Fusion Inc. reported Phase 1 results for BMF-650, its investigational oral glucagon-like peptide-1 (GLP-1) receptor agonist developed for obesity and metabolic disorders.
The study showed weight reduction across multiple dose cohorts over four weeks, with encouraging tolerability findings.
Obesity is a chronic disease characterized by excess body fat and an increased risk of conditions such as type 2 diabetes and cardiovascular disease. GLP-1 receptor agonists act on pathways involved in appetite regulation and glucose metabolism.
BMF-650 is an investigational oral small-molecule GLP-1 receptor agonist designed to support weight reduction while limiting gastrointestinal adverse effects and simplifying dose titration.
The randomized, double-blind, placebo-controlled Phase 1 study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMF-650 in otherwise healthy adults who were overweight or obese. The trial included a single-ascending-dose portion and five multiple-ascending-dose cohorts.
In Cohorts 1-4, mean weight reduction at Day 29 ranged from 1.5% to 3.2%, compared with 0.1% for pooled placebo participants. At doses of 200 mg or higher once daily, mean weekly weight reduction was approximately 0.97 kg.
The company said additional data analysis is ongoing, with results expected to be presented at a future medical meeting.
In the fifth cohort, participants received 200 mg once daily for one week, followed by 400 mg once daily for three weeks.
Mean weight reduction at Day 29 was 6.1%, or approximately 6.2 kg. However, similar weight reduction was observed in two placebo participants who consumed only about 33% of the provided food during the confinement study. The company noted these results should be interpreted separately from those of the other cohorts.
Across the five active-dose cohorts (n=40), all treatment-emergent adverse events were mild or moderate.
No severe or serious events, adverse-event-related dose modifications or treatment discontinuations were reported. Nausea occurred in 17.5% of participants, vomiting in 7.5%, constipation in 10% and diarrhea in 5%. No elevations in liver enzymes ALT or AST were reported.
Biomea noted that longer-duration studies and additional clinical data are needed to determine the optimal dosing regimen. Further development will also require longer-term toxicology studies, while the company is positioning BMF-650 for a potential strategic partnership or licensing arrangement.
Biomea Fusion Interim CEO, Mick Hitchcock said, “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.”
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