Biomea Fusion Presents COVALENT-111 Study Results at the 23rd World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC)

Core Insights - Biomea Fusion, Inc. presented positive results from the COVALENT-111 study at the 23rd WCIRDC, demonstrating durable glycemic and C-peptide improvements with icovamenib, a menin inhibitor for type 2 diabetes [1][2] Study Results - The COVALENT-111 study showed significant improvements in HbA1c and C-peptide responses at week 52, which is 9 months post the last dose of icovamenib [3] - Higher reductions in HbA1c were correlated with increased exposure to icovamenib, indicating a dose-response relationship [9] - The treatment was well-tolerated, with no discontinuations due to adverse events and no serious adverse events reported [9] Study Design - COVALENT-111 is a double-blind, randomized, placebo-controlled trial involving adult patients diagnosed with type 2 diabetes (T2D) within the last 7 years, with HbA1c levels between 7.0% and 10.5% and a BMI between 25 and 40 kg/m² [5] - Participants were treated with lifestyle management and had inadequate glycemic control despite treatment with up to three antidiabetic medications [5] - The study evaluated icovamenib in three dosing regimens: 100mg once daily for 8 weeks, 100mg once daily for 12 weeks, and a combination of 100mg once daily for 8 weeks followed by 100mg twice daily for 4 weeks [5] About Icovamenib - Icovamenib is an investigational, orally bioavailable, potent, and selective covalent inhibitor of menin, aimed at enhancing the function and quantity of insulin-producing beta cells [6] - It represents a first-in-class approach in diabetes treatment, potentially becoming a significant addition to the diabetes treatment landscape upon successful completion of clinical studies [6] Company Overview - Biomea Fusion is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies for diabetes and obesity, targeting metabolic disorders affecting a significant portion of the global population [7] - The company's mission is to deliver transformative treatments that restore health for patients living with diabetes, obesity, and related conditions [7]