FDA Lifts Clinical Hold on BMF-219 in Type 2 and Type 1 Diabetes Trials

Core Insights - The U.S. FDA has lifted the clinical hold on Biomea Fusion's Phase I/II trials for the investigational covalent menin inhibitor BMF-219, which targets type 1 and type 2 diabetes [1][2] Company Overview - Biomea Fusion, Inc. is a clinical-stage biopharmaceutical company focused on developing oral covalent small molecules for metabolic diseases and genetically defined cancers [7] - The company utilizes its proprietary FUSION™ System to design and develop next-generation covalent-binding small molecule medicines [8] Clinical Trials - The ongoing trials include COVALENT-111 for type 2 diabetes and COVALENT-112 for type 1 diabetes, with the latter involving approximately 150 patients [4][5] - COVALENT-111 is a multi-site, randomized, double-blind, placebo-controlled Phase I/II study, while COVALENT-112 is a Phase II study comparing two doses of BMF-219 to placebo [4][5] - The Phase IIb Expansion Study of COVALENT-111 has shown no concerning safety signals translating from the earlier Phase 2a Escalation Study [2] Upcoming Milestones - The company plans to announce a third development candidate, a GLP-1 receptor agonist, and expects topline data readouts for both COVALENT-111 and COVALENT-112 in Q4 2024 [4]