COVALENT-111 is a multi-site, randomized, double-blinded, placebocontrolled Phase I/II study, clinically investigating Biomea's study medication, BMF-219, in adults with type 2 diabetes, yet uncontrolled by current therapies. The total study duration including the follow up period is up to 52 weeks. However, BMF-219 will only be dosed (orally, daily) for up to 12 weeks.
In March 2023, Biomea announced initial positive safety and efficacy data for the first two cohorts of patients with type 2 diabetes enrolled in the Phase II portion of the trial. After 4 weeks of oncedaily 100 mg dosing with the investigational, oral covalent menin inhibitor, BMF-219, 89% of patients achieved a reduction in A1c, 78% of patients achieved at least a 0.5% reduction in A1c, and 56% achieved at least a 1% reduction in A1c. Later in June 2023, Biomea reported updated clinical data from the first two cohorts of ongoing Phase II COVALENT-111 study at the American Diabetes Association (ADA) 83rd Scientific Sessions showing positive continued patient improvements while being off therapy, 8 weeks after the last dose.
Criteria:-A diagnosis of type 2 diabetes within the past 7 years
-Type 2 diabetes treated with diet and physical activity, with or without at most 3 diabetes medications
-HbA1c between≥7.0% and ≤10.5%
-BMI 25-40