Biomea Fusion pivots to diabetes & obesity; icovamenib shows 1.5% HbA1c drop in insulin-deficient patients

Biomea Fusion, Inc.

Placebo-adjusted 1.5% mean HbA1c reduction in severe insulin-deficient T2D patients after 12 weeks of icovamenib, sustained 14 weeks off treatment.
Placebo-adjusted 1.0% HbA1c reduction in patients uncontrolled on GLP-1 therapies, consistent with preclinical synergy with semaglutide.
100% of severely insulin-deficient patients on 100 mg icovamenib responded with durable HbA1c decline; no drug-related adverse events.
Company plans to end oncology studies, seek partnerships, and focus on two late-stage trials: Phase 2/3 in insulin-deficient T2D and Phase 2b combo with GLP-1.
Novel oral menin inhibitor designed to regenerate beta cells; FDA discussions expected to support late-stage development.

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