Biomea Fusion announces positive 52-week results from phase 2 COVALENT-112 trial

Biomea Fusion (BMEA) “announced positive 52-week results from its Phase 2 COVALENT-112 trial evaluating the efficacy, safety, and tolerability of icovamenib in patients with type 1 diabetes. These data are based on a proof-of-concept study enrolling small subsets of Stage 3 T1D patients dosed with icovamenib at 100 mg and 200 mg in two cohorts. The COVALENT-112 trial demonstrated encouraging results in patients with T1D. In patients diagnosed within 0-3 years, treatment with icovamenib 200 mg once daily for 12 weeks resulted in a 52% increase in mean C-peptide area under the curve (AUC) at Week 12 (p less than 0.001; n=5), representing a magnitude of improvement that is not commonly reported in published studies of T1D. Importantly, the effect was durable following only 12 weeks of dosing, mean C-peptide AUC was largely preserved through Week 52, representing approximately a 7% decline from baseline. A dose response was observed, with the 200 mg dose demonstrating greater activity compared to 100 mg. Published natural history data suggest that patients with Stage 3 T1D typically experience substantial declines in C-peptide over time, underscoring the significance of preserved C-peptide following only a 12-week dosing period.”