Biomea Fusion reports Phase 2 COVALENT-112 positive topline: 52% C-peptide increase in early T1D

Biomea Fusion, Inc.

In patients diagnosed within 3 years, icovamenib 200mg QD for 12 weeks increased mean C-peptide AUC by 52% (p<0.001, n=5) at Week 12; effect sustained with ~7% decline from baseline at Week 52.
Dose response observed; longer-standing T1D (3-15 years) preserved C-peptide through Week 52 with only modest decline.
Company plans Phase 2 trial with extended dosing (6-12 months) plus immunosuppressant, to start H2 2026 at four U.S. academic centers.
Study enrollment interrupted due to FDA clinical hold (resolved); data reflects about half intended population; no placebo control completed.
Icovamenib generally well tolerated; comprehensive data to be presented at ADA Scientific Sessions in June 2026.

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