U.S. FDA places clinical hold on Biomea's diabetes trials
Adds details about drug and FDA decision throughout, shares in paragraph 2
June 6 (Reuters) -Biomea Fusion BMEA.O said on Thursday the U.S. Food and Drug Administration had placed a clinical hold on ongoing studies of its experimental drug for type 1 and 2 diabetes due to liver toxicity concerns.
Shares of the company were down61.5% in after-hours trading.
The drug, BMF-219, was being tested in an early-to-mid stage study for type 2 diabetes and a mid-stage study in type 1 diabetes.
The drug developer said the FDA cited deficiencies based on the level of possible drug-induced toxic liver disease observed in the completed dose escalation phase of the type 2 diabetes trial.
Higher doses of up to 400 milligrams, various food intake regimens, medical history and accompanying medications may have contributed to observed liver enzyme elevations, the company said.
Biomea said it is working with the regulator to put a plan in place to ensure patient safety and resume the studies.
The company said it will continue its ongoing safety and efficacy data collection during the hold.
BMF-219 works by increasing, preserving, and reactivating patients' own healthy insulin-producing cells.
Biomea said no serious adverse reactions have been reported to date in the studies.
Reporting by Puyaan Singh in Bengaluru; Editing by Maju Samuel
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