Biomea Fusion Announces Positive Topline Results from Ongoing Phase II COVALENT-111 Study in Patients with Type 2 Diabetes

• Icovamenib met the primary endpoint, displaying a meaningful statistically significant placebo-corrected mean reduction in HbA1c in the prespecified per protocol patient population
• Best response achieved in target, beta-cell deficient patients on one or more antidiabetic agents at baseline, showing a placebo-adjusted mean reduction of 1.47% in HbA1c at Week 26 with statistical significance, after only 12 weeks of dosing icovamenib with 100 mg
• Icovamenib was well-tolerated, with no adverse-event related discontinuations, no hypoglycemic events and no serious adverse events

Excerpt from the Press Release:

REDWOOD CITY, Calif., Dec. 17, 2024 (GLOBE NEWSWIRE) — Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to improve the lives of patients with diabetes, obesity, and genetically defined cancers, today announced positive topline results from the ongoing COVALENT-111 study, evaluating the efficacy, safety and tolerability of icovamenib in patients with type 2 diabetes (T2D).

COVALENT-111 is a double-blinded, randomized, 3:1 placebo-controlled trial that has enrolled adult patients diagnosed with T2D within the last 7 years, who had HbA1c levels between 7.0% and 10.5%, and a body mass index (BMI) between 25 and 40 kg/m². At baseline, all participants were receiving treatment with diet and exercise and were uncontrolled with up to three antidiabetic medications. Icovamenib was investigated in three different dosing arms with a primary follow up after 26 weeks which we are reporting on today: Arm A at 100mg QD (once daily) for 8 weeks, Arm B at 100mg QD for 12 weeks, and Arm C at 100 mg QD for 8 weeks and 100mg BID (twice daily) for 4 weeks. The study enrolled a total of 225 patients that received at least one dose of icovamenib and were considered evaluable for the modified intent-to-treat population (mITT). Dosing was interrupted for many patients due to an interim clinical hold imposed by the U.S. Food and Drug Administration (FDA). This topline efficacy analysis focuses on those patients who had completed at least 80% of their dosing prior to the clinical hold and who at baseline were treated with one or more anti-hyperglycemic therapy, the Per Protocol Patient population (n=168).

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