FDA Halts Two Biomea Diabetes Studies

The FDA has imposed clinical holds on two Phase I/II trials of Biomea Fusion’s covalent menin inhibitor, BMF-219. These trials, known as COVALENT-111 and COVALENT-112, are investigating the drug for type 2 and type 1 diabetes, respectively. Following this news, Biomea Fusion’s stock plummeted by approximately 60% in after-hours trading on Thursday.

The clinical hold was instigated after the FDA identified potential concerns regarding drug-induced liver toxicity in the initial dose-escalation stage of the COVALENT-111 trial. The FDA reported elevated liver enzyme levels in participants, which could have been influenced by various factors, including different food intake regimens, patients’ medical histories, concurrent medications, or higher doses of BMF-219.

Thomas Butler, CEO of Biomea Fusion, underscored the importance of patient safety and assured that the company is actively collaborating with the FDA. Butler emphasized that Biomea Fusion is working diligently to develop a plan that ensures patient safety and aims to resume the trials once they receive FDA approval.

This incident is not unprecedented. In 2021, the FDA placed a partial hold on Kura Oncology’s study of a selective menin inhibitor, KO-539, due to a patient’s death potentially linked to differentiation syndrome. This historical context highlights the FDA's cautious approach when it comes to the safety of menin inhibitors in clinical trials.

In summary, the FDA’s decision to place clinical holds on Biomea Fusion’s trials of BMF-219 has raised significant concerns about the drug’s safety profile, particularly regarding liver toxicity. Biomea Fusion is committed to addressing these issues and resuming the trials once they have ensured the safety of participants.