Clinical TrialApr 27, 2026, 05:40 PM
BMEA Icovamenib Phase 2 T1D shows 52% C-peptide increase
AI Summary
Biomea Fusion, Inc. announced positive 52-week results from its Phase 2 COVALENT-112 trial for icovamenib in Type 1 Diabetes (T1D). Patients diagnosed within 0-3 years receiving 200 mg icovamenib showed a 52% increase in mean C-peptide AUC at Week 12, with effects largely preserved through Week 52. The drug was well-tolerated, and the company plans a new Phase 2 trial in collaboration with academic centers, starting in H2 2026, to evaluate extended dosing and combination therapy. A comprehensive dataset will be presented at the ADA Scientific Sessions in June.
Key Highlights
- Icovamenib 200 mg led to a 52% increase in mean C-peptide AUC at Week 12 in T1D patients (0-3 years diagnosis, n=5).
- C-peptide AUC was largely preserved through Week 52 (~7% decline from baseline) after only 12 weeks of dosing.
- C-peptide preservation also observed in patients diagnosed 3-15 years (n=9).
- Icovamenib demonstrated a favorable safety and tolerability profile through Week 52.
- Company plans a new Phase 2 trial in H2 2026 with 4 U.S. academic centers.
- Full dataset to be presented at ADA Scientific Sessions in June.
- Conference call to discuss results on April 28 at 8:30 am ET.