Biomea Fusion, Inc. announced FDA and Health Canada clearance of the expansion portion of the ongoing COVALENT-111 Phase II study. The objective of the expansion portion is to continue to investigate BMF-219 with treatment durations up to 12 weeks. It is an important milestone as the data from this trial will further inform development plans and discussions with the FDA and Health Canada.

The momentum of study is continuing to build with new sites coming onboard quickly and enrollment surpassing internal expectations. The momentum of study is continue to build with new sites coming on quickly and enrollment surpassing internal expect to reporting results from this study in the coming year. COVALENT-111 is a multi-site, randomized, double-blinded, placebo-controlled Phase I/II study.

In the completed Phase I portion of the trial, healthy subjects were enrolled in single ascending dose cohorts. Additional information about the Phase I/II clinical trial of BMF-219 in type 2 diabetes can be found at ClinicalTrials.gov using the identifier NCT05731544. The company are utilizing proprietary FUSION?

System to discover, design and develop a pipeline of next-generation covalent-binding small molecule medicines designed to maximize clinical benefit for patients with various cancers and metabolic diseases, including diabetes.