FDA Halts Biomea Fusion's Diabetes Drug Trials Due to Hepatotoxicity Concerns

Key Insights

• The FDA has placed a full clinical hold on Biomea Fusion's Phase I/II trials for BMF-219, a drug being developed for type 1 and type 2 diabetes, due to potential liver toxicity.
• The decision was prompted by elevated liver enzyme levels observed during the dose escalation phase of the COVALENT-111 and COVALENT-112 trials, though most adverse events were mild to moderate.
• Biomea Fusion's stock price plummeted by over 60% following the announcement, reflecting investor concerns about the future of BMF-219 and the company's clinical development program.

The FDA has halted Biomea Fusion's Phase I/II clinical trials for BMF-219, an investigational drug for type 1 and type 2 diabetes, following concerns about potential drug-induced hepatotoxicity. The decision, announced Friday, led to a significant drop in Biomea Fusion's stock price. The trials, known as COVALENT-111 and COVALENT-112, are designed to evaluate the safety and efficacy of BMF-219 in patients with type 2 and type 1 diabetes, respectively.

Hepatotoxicity Concerns

The FDA's decision was based on observations of elevated liver enzyme levels during the dose escalation phase of the trials. While the majority of adverse events reported were mild to moderate, the potential for liver toxicity raised significant safety concerns, prompting the regulatory agency to impose a full clinical hold. The specific levels and frequency of liver enzyme elevations were not disclosed in the initial announcement.

Company Response

Thomas Butler, CEO and Chairman of Biomea Fusion, stated the company's commitment to patient safety and ongoing collaboration with the FDA to resolve the issues and resume the trials. He emphasized the potential of BMF-219 to restore glucose-controlled insulin production and improve glycemic control in patients with diabetes.

BMF-219: Mechanism and Potential

BMF-219 is an investigational covalent menin inhibitor. The company has previously presented data showing a placebo-adjusted mean reduction in HbA1c of 0.8% at Week 26 for participants in the 100 mg BMF-219 QD (without food) cohort in type 2 diabetes patients. The mechanism of action is designed to improve glycemic control.

Trial Details and Next Steps

Biomea Fusion will continue to collect safety and efficacy data from the ongoing trials while working to address the FDA's concerns. The company has not provided a specific timeline for when it expects the clinical hold to be lifted. Further investigations will likely be required to fully characterize the nature and extent of the observed hepatotoxicity and to identify potential risk factors.