Biomea Fusion, Inc. (BMEA) has released preliminary outcomes from the COVALENT-111 study, which investigates the efficacy, safety, and tolerability of Icovamenib in type-2 diabetes patients.
The study is a double-blind, placebo-controlled trial with a 3:1 randomization ratio, targeting adults diagnosed with type-2 diabetes in the past seven years. Eligible participants had HbA1c levels ranging from 7.0 to 10.5 percent and a body mass index between 25 and 40 kg/m².
Icovamenib was tested in three different dosing regimens: Arm A received 100 mg once daily for eight weeks; Arm B received the same daily dose for twelve weeks; and Arm C received 100 mg once daily for eight weeks followed by 100 mg twice daily for four weeks.
By the 26th week, participants who adhered to the dosing protocol showed statistically significant reductions in their HbA1c levels. The study reported no drug-to-drug interactions.
Biomea Fusion intends to engage with the FDA on advancing Icovamenib as a pioneering menin inhibitor for type-2 diabetes treatment. The company aims to explore secondary endpoints, examining variables such as HbA1c reduction, fasting glucose levels, and HOMA-B and HOMA-IR indices, within detailed subtypes to uncover specific response patterns.
Phase 2 results of this study are expected to be presented at a forthcoming medical conference in 2025.
Despite these developments, Biomea's stock is currently experiencing a decline of 14.60%, trading at $5 on the Nasdaq.
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