Biomea Fusion, Inc. (BMEA), Tuesday announced topline data from the ongoing COVALENT-111 study, evaluating the efficacy, safety, and tolerability of Icovamenib in patients with type-2 diabetes.
The double-blinded, randomized, 3:1 placebo-controlled trial involved adult patients diagnosed with type-2 diabetes within the last 7 years, who had HbA1c levels between 7.0 and 10.5 percent, and a body mass index between 25 and 40 kg/m.
Icovamenib was administered to participants in three different dosing arms -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.
At Week 26, the patients who completed the dosing per protocol demonstrated statistically significant reductions in HbA1c levels. Moreover, no drug-to-drug interactions were observed during the study.
Based on the data, the company plans to discuss with FDA on how to further advance Icovamenib as a first-in-class menin inhibitor therapy for type-2 diabetes.
Looking ahead, the company plans to assess secondary endpoints, such as HbA1c reduction, fasting glucose, HOMA-B and HOMA-IR within each pre-specified subtype to identify distinct patterns of response.
The phase 2 data of the study will be announced at an upcoming medical conference in 2025.
Currently, Biomea's stock is falling 14.60 percent, to $5 on the Nasdaq.
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