Biomea Fusion announces FDA clearance of IND application for BMF-219

Biomea Fusion announced the U.S. Food and Drug Administration, FDA, has cleared Biomea’s IND application to study BMF-219 in adults with type 1 diabetes. The objective of COVALENT-112 is to evaluate the safety, efficacy, and durability of BMF-219, a covalent menin inhibitor, in potentially restoring beta cell function. “Our initial clinical data has demonstrated that BMF-219 is potentially disease modifying for people with type 2 diabetes. We have been diligent to build a program that will evaluate most people with diabetes, including those with type 1 diabetes. Last week we announced the expansion of our existing Phase I/II study enrolling approximately 300 additional patients with type 2 diabetes. Today, we are thrilled to announce that the FDA has also cleared our IND to study BMF-219 in type 1 diabetes. Our new study, COVALENT 112, is designed to enroll 150 patients with type 1 diabetes,” stated Thomas Butler, Biomea Fusion’s Chief Executive Officer and Chairman of the Board. He further added, “I am immensely proud that Team Fusion has achieved these clinical and regulatory milestones more than 3 months ahead of our guided timelines. We have now established a clinical development plan that we believe will fully explore the potential of BMF-219 across the spectrum of diabetes. The next quarters will be very exciting as we expect these studies will begin to read out.”