Biomea Fusion’s Icovamenib Boosts C-Peptide 52% at Week 12, Durable to Week 52
Biomea Fusion’s 200 mg icovamenib cohort in Stage 3 Type 1 diabetes patients saw a 52% mean C-peptide AUC increase at Week 12 (p<0.001; n=5) compared to baseline, with only a 7% decline from baseline at Week 52. A clear dose response favored 200 mg over 100 mg, and no new safety signals emerged through one year.
1. Trial Design and Patient Cohorts
COVALENT-112 is a Phase 2 open-label trial enrolling Stage 3 Type 1 diabetes patients diagnosed either within 0–3 years or 3–15 years. Participants received 100 mg or 200 mg of icovamenib once daily for 12 weeks, followed by a 40-week follow-up to assess C-peptide durability.
2. Efficacy Results and Dose Response
In the early-diagnosed cohort (n=5 at 200 mg), mean C-peptide AUC rose by 52% at Week 12, with p<0.001, versus baseline. A clear dose response was observed, with the 200 mg group outperforming the 100 mg group (n=6) in C-peptide improvement.
3. Durability Through Week 52
The 200 mg cohort maintained C-peptide levels with only a 7% decline at Week 52, demonstrating durable beta cell function. Patients diagnosed 3–15 years prior also showed preserved C-peptide through Week 52 following 12 weeks of treatment.
4. Safety and Next Steps
Icovamenib was well tolerated with no new safety signals over 52 weeks. Biomea plans a Phase 2 trial this year to explore extended 200 mg dosing and potential immunosuppressive combinations at four U.S. academic centers.