Biomea Fusion says FDA lifts clinical hold on BMF-219 trials

Biomea Fusion announced that the U.S. Food and Drug Administration has lifted the clinical hold on Biomea’s ongoing Phase I/II clinical trials of the company’s investigational covalent menin inhibitor BMF-219 in type 2 and type 1 diabetes, respectively. “We greatly appreciate FDA’s review of our data, and the swift resolution of the clinical trial hold. The in-depth review of the clinical data to date reconfirms our confidence in BMF-219 as a novel, first-in-class agent for the treatment of diabetes. We are encouraged from the safety review of the ongoing Phase 2b Expansion Study, where the concerning safety signals seen in the Phase 2a Escalation Study did not translate over to the larger Expansion Study. And most importantly, none of the elevated lab values translated to confirmed serious liver injury or liver impairment,” stated Thomas Butler, Biomea Fusion’s Chief Executive Officer and Chairman of the Board. “We look forward to continuing our robust development plan for BMF-219 following full resumption of our ongoing studies, COVALENT-111 and COVALENT-112.”