Biomea Fusion announces 52-week results from COVALENT-111 study

Biomea Fusion (BMEA) announced 52-week results from its Phase II COVALENT-111 study evaluating the efficacy, safety, and tolerability of icovamenib in patients with type 2 diabetes. The study evaluated icovamenib in three dosing regimens: Arm A at 100mg once daily for 8 weeks, Arm B at 100mg once daily for 12 weeks, and Arm C at 100 mg once daily for 8 weeks and 100mg twice daily for 4 weeks. A total of 267 patients received at least one dose of icovamenib and were considered evaluable for the modified intent-to-treat population. As previously reported, dosing was interrupted by an interim clinical hold imposed by the FDA. The topline efficacy analysis presented here includes the patient population who had completed at least 80% of their planned dosing prior to the clinical hold and who, at baseline, were treated with one or more antihyperglycemic agents. As prespecified in the statistical analysis plan, outcomes were prospectively evaluated by diabetes phenotype using the Ahlqvist algorithm. The study results, while exploratory, through Week 52 across multiple subgroups, with certain groups demonstrating statistically significant and clinically meaningful reductions in HbA1c observed nine months after dosing. In the 26-week analysis, 8 weeks of dosing was found to be less effective than 12. Accordingly, the 52-week readout primarily focused on patients in Arms B and C who received 12 weeks of treatment. Among these severe insulin-deficient patients, icovamenib achieved a durable HbA1c reduction of 1.2% sustained through Week 52. The strongest performing arm for this prespecified population was Arm B with a mean HbA1c reduction of 1.5%. Severe insulin-deficient diabetes is characterized by impaired insulin secretion, the lowest beta cell function among T2D subtypes, and rapid disease progression. This group was prospectively defined prior to unblinding and represents a population with substantial unmet need. The 52-week analysis also showed clinically meaningful benefit in study participants who were receiving a GLP-1-based therapy but had not achieved glycemic targets at study entry. In this subgroup, 8 or 12 weeks of icovamenib resulted in a 1.3% reduction in HbA1c with effects sustained through Week 52. Icovamenib maintained a favorable safety profile throughout the 52-week observation period. There were no treatment-related serious adverse events or discontinuations due to adverse events. Across all dosing arms, icovamenib was generally well tolerated.