Biomea Fusion Announces Completion of Enrollment of First 3 Arms in Phase 2 Expansion Cohorts of COVALENT-111 Study for BMF-219 in Type 2 Diabetes

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[{"type":"text","content":"BMF-219 is an investigational novel covalent menin inhibitor developed to regenerate insulin-producing beta cells\nREDWOOD CITY, Calif., May 30, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, today announced the completion of enrollment of the first three dose expansion arms of COVALENT-111, with a total of over 260 type 2 diabetes patients enrolled. The COVALENT-111 study is a multi-site, randomized, double-blind, placebo-controlled Phase I/II study. Phase II consists of multiple dose escalation and dose expansion cohorts including adult patients with type 2 diabetes uncontrolled by standard of care medicines. The dose escalation phase is evaluating BMF-219 dosed over 4 weeks with 22 weeks follow-up off treatment. The first three arms (A, B, C) of the expansion phase are evaluating BMF-219 dosed over 8 and 12 weeks at 100 mg and 200 mg with up to 40 weeks of follow-up off treatment. 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. “We are thrilled to announce the important milestone of completing enrollment of the first three expansion arms of COVALENT-111. In the dose escalation arms, after only 4 weeks of BMF-219 dosing, many participants demonstrated durable glycemic control at Week 26. To date, we have not seen an agent with such a profound impact on type 2 diabetes while off therapy. BMF-219 is unique in that it directly addresses the root cause of diabetes by proliferating the failing pool of beta cells. We are now excited to see how the impact of BMF-219 may be improved by a longer, 8 to 12-week dosing regimen.” stated Juan Pablo Frias, MD, Biomea Fusion’s Chief Medical Officer. He added, “The expansion phase builds upon our early learnings and supports a more patient centric approach to treatment as we investigate the heterogeneity of type 2 diabetes. We look forward to presenting our topline Week 26 data of our first three expansion arms of COVALENT-111 in Q4 2024.” About COVALENT-111 COVALENT-111 is a multi-site, randomized, double-blind, placebo-controlled Phase I/II study. In...

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