Biomea Fusion announced dosing of the first patient with type 2 diabetes in the Phase II portion of COVALENT-111 in the U.S. This trial is a randomized, double-blinded, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of six dose levels of BMF-219 administered orally daily in 28-day cycles followed by a 26-week evaluation period. "We are thrilled to announce this milestone so soon after receiving IND clearance from the FDA in December. BMF-219 is potentially capable of addressing and modifying a major driver of type 2 diabetes, beta cell health and function. We believe that this oral agent has the potential to obviate the need for multiple concurrent treatments, including insulin injections," stated Thomas Butler, Biomea Fusion’s Chief Executive Officer, and Chairman of the Board. "We look forward to presenting initial data from the Phase II portion of COVALENT-111 later this year as we march toward our goal of delivering a transformational therapy for patients with diabetes."
Published first on TheFly
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