Clinical TrialJun 5, 2026, 07:33 PM
Biomea Fusion Icovamenib Data Shows T1D/T2D Benefits, Metabolic Health
AI Summary
Biomea Fusion presented new clinical and translational data for its investigational oral menin inhibitor, icovamenib, at the American Diabetes Association 86th Scientific Sessions. The data highlighted icovamenib's potential to improve endogenous insulin secretion and glycemic control in both Type 1 and Type 2 diabetes, with translational data supporting muscle preservation and fat reduction. Additionally, the company expanded its Phase I study for BMF-650, an oral GLP-1 receptor agonist, to optimize dose selection and evaluate a rapid one-step titration for enhanced weight loss potential.
Key Highlights
- Icovamenib increased C-peptide AUC by approximately 52% at Week 12 in T1D patients (<3 years diagnosis).
- C-peptide AUC remained approximately 7% below baseline at Week 52 in T1D, versus 47% annual decline in historical placebo.
- Icovamenib showed a 1.2% HbA1c mean reduction at Week 52 in T2D patients on GLP-1 RA therapy.
- Placebo-adjusted HbA1c mean reduction was 1.8% in inadequately controlled T2D patients.
- Translational data showed icovamenib enhanced GLP-1 expression and receptor expression.
- BMF-650 Phase I study expanded to evaluate rapid one-step titration (200 mg QD for 1 week, then 400 mg QD for 3 weeks).
- Initial 28-day clinical weight reduction data for BMF-650 is anticipated in Q3 2026.
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