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Biomea Fusion Announces FDA and Health Canada Clearance of the Expansion Cohorts of the Ongoing COVALENT-111 Phase II Study
The FDA and Health Canada have cleared the initiation of the expansion portion of COVALENT-111, which will evaluate BMF-219 administered at 100 mg and 200 mg,
About this update from Biomea Fusion, Inc.
[{"type":"text","content":"The FDA and Health Canada have cleared the initiation of the expansion portion of COVALENT-111, which will evaluate BMF-219 administered at 100 mg and 200 mg, with dosing durations up to 12 weeks in type 2 diabetes patientsThe expansion portion will consist of approximately 300 patients and will begin to enroll three cohorts immediately, with a fourth cohort following the completion of the escalation portionCompared to baseline, 84% of all patients dosed for four weeks with BMF-219 (n=32) in the escalation portion of COVALENT-111 showed a reduction in HbA1c at Week 4 and 74% at Week 12, two months after the final dose of BMF-219Topline results of the escalation portion anticipated in Q4 2023 REDWOOD CITY, Calif., Sept. 28, 2023 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, today 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. “We’ve seen truly groundbreaking data to date with BMF-219’s novel mechanism of action focused on addressing an underlying cause of type 2 diabetes – the loss of healthy, insulin-producing beta cells,” said Juan Pablo Frias, M.D., Chief Medical Officer at Biomea. “As we learned from our preclinical studies and now with the early clinical data, patients present with various levels of beta cell function, which supports extending the treatment period beyond four weeks in order to maximize the degree and durability of improvement in glycemic control. The expansion portion of COVALENT-111 is designed to build on the impressive findings thus far, and more deeply interrogate and define BMF-219 as a potential treatment for a large portion of the type 2 diabetes patient population.” Thomas Butler, Biomea’s Chief Executive Officer and Chairman of the Board, commented, “We are excited to begin the expansion portion of COVALENT 111. It is an important milestone as the data from this trial will further inform development plans and our discussions with the FDA and Health Canada.” He further added, “BMF-219 has co...