Mar. 15 at 4:22 PM
$BMEA Biomea Fusion presents Phase II Covalent-111 data in Type 2 Diabetes
Biomea Fusion announced that Juan Pablo Frias, MD, delivered an oral presentation at the 19th International Conference on Advanced Technologies & Treatments for Diabetes in Barcelona on March 14, 2026 highlighting positive 52-week follow-up results from the Company's Phase II COVALENT-111 study evaluating the efficacy, safety, and tolerability of icovamenib in patients with type 2 diabetes. The study showed positive results, while exploratory, through Week 52 across multiple subgroups, with certain groups demonstrating statistically significant and clinically meaningful reductions in HbA1c, the gold standard for assessing glycemic control in T2D, 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 the severe insulin-deficient patients, icovamenib achieved anHbA1c reduction that improved over time reaching 1.2% at 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.
