FDA slaps clinical hold on pair of diabetes studies from Biomea

06 Jun 2024
firstwordpharma.com
Clinical Study
The FDA placed full clinical holds on two Phase I/II trials of Biomea Fusion’s covalent menin inhibitor BMF-219, which is being tested in the COVALENT-111 study for type 2 diabetes and in the COVALENT-112 trial for type 1 diabetes. The news sent Biomea’s shares down about 60% during after-hours trading on Thursday.
The hold was triggered after the US regulator found “deficiencies based on the level of possible drug-induced hepatotoxicity” in the already-completed dose-escalation portion of COVALENT-111.
The FDA observed liver enzyme elevations in study participants, but said various food intake regimens, medical history, concomitant medications, or higher doses of BMF-219 may have contributed to the effect.
Biomea CEO Thomas Butler said that “patient safety is paramount” and that the company is “fully collaborating and working diligently with the FDA to put a plan in place as quickly as possible to ensure patient safety and look forward to resuming the studies once we have authorization from the FDA.”
It’s not the first time the FDA has paused a clinical trial of a menin inhibitor. In 2021, the regulator placed a partial hold on a study of Kura Oncology’s selective menin inhibitor KO-539 in patients with relapsed or refractory acute myeloid leukaemia following a patient death potentially associated with differentiation syndrome.
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