Biomea Fusion Announces BMF-219 in Diabetes Placed on Clinical Hold

Core Viewpoint - Biomea Fusion, Inc. has received a full clinical hold from the FDA on its Phase I/II clinical trials for the investigational covalent menin inhibitor BMF-219, affecting studies in type 2 and type 1 diabetes, while the company continues to collect safety and efficacy data during this period [2][3][7] Group 1: Clinical Trials Overview - COVALENT-111 is a multi-site, randomized, double-blind, placebo-controlled Phase I/II study evaluating BMF-219 in type 2 diabetes, with the completed Phase I portion involving healthy patients and the Phase II portion including adults with uncontrolled type 2 diabetes [4] - The trial includes an open-label portion for adults with type 1 diabetes, examining the efficacy and safety of BMF-219 at two oral doses (100 mg and 200 mg) over a 12-week treatment period followed by a 40-week off-treatment period [5] - COVALENT-112 is a Phase II study in adults with stage 3 type 1 diabetes, comparing two doses of BMF-219 to placebo, with approximately 150 patients expected to enroll [8] Group 2: Safety and Efficacy Data - The FDA's clinical hold was due to observed drug-induced hepatotoxicity during the Dose Escalation Phase of COVALENT-111, with liver enzyme elevations potentially linked to higher doses and other factors [3] - Despite the clinical hold, the company reports that the majority of adverse events have been mild to moderate, with no serious adverse reactions reported to date [3][7] - The CEO of Biomea Fusion emphasized the commitment to patient safety and the potential of BMF-219 to improve glycemic control and restore insulin production based on existing safety and efficacy data [7] Group 3: Company Background - Biomea Fusion is a clinical-stage biopharmaceutical company focused on developing oral covalent small molecules for metabolic diseases and genetically defined cancers, aiming to provide greater target selectivity and durable responses compared to conventional drugs [10]