Icovamenib (BMF-219) - (COVALENT-111)

June 5, 2026: Biomea Fusion, Inc. (NASDAQ: BMEA) announced new clinical and translational presentations at the ADA 86th Scientific Sessions (June 5–8, 2026) for icovamenib (oral menin inhibitor) and an expansion of its Phase 1 study for BMF-650 (oral GLP-1 receptor agonist).

Icovamenib (ADA posters):

• Translational MOA (Poster 2871-LB): In cell models, icovamenib increased GLP-1 expression in human colon L-cells and GLP-1 receptor expression in human islets; showed myogenic effects in human skeletal muscle cells (e.g., increased myotube size and myosin heavy chain expression); and promoted adipocyte browning/lipolysis (e.g., reduced lipid droplet size, increased glycerol release), supporting potential utility in metabolic health/obesity and possible complementarity with GLP-1 RAs.
• Type 1 diabetes, Phase 2 COVALENT-112 (Poster 2858-LB): 52-week findings showed enhancement/preservation of endogenous insulin secretion; in Cohort 1 (<3 years since diagnosis), 200 mg increased C-peptide AUC ~52% at Week 12 and was ~7% below baseline at Week 52; cytokine profiling showed no systemic immune activation; generally well tolerated with no new safety signals.
• Type 2 diabetes, Phase 2 COVALENT-111 subgroup on background GLP-1 RA (Poster 2857-LB): HbA1c improvements through Week 52 (including 40 weeks post-discontinuation); Week 52 HbA1c -1.2% vs placebo +0.6% (placebo-adjusted -1.8%); improved C-peptide index; no serious AEs or discontinuations due to AEs.

BMF-650 (GLP-131 Phase 1): Completed SAD and four MAD cohorts; added an additional MAD cohort to test rapid one-step titration (200 mg QD for 1 week then 400 mg QD for 3 weeks) to optimize weight reduction and Phase 2 dose selection. Initial 28-day weight reduction data are expected in Q3 2026.