Clinical Trial 56264

Chicago, IL 60607


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.


-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

Qualified Participants May Receive:

BMF-219 is the investigational agent used in our study COVALENT-111. It is being evaluated for its potential to treat a root cause of diabetes. BMF-219 is designed to directly target menin which controls the regeneration of insulinproducing beta cells. In preclinical and in early clinical studies, BMF-219 has shown to improve the function of beta cells and thereby increase the natural production of insulin. Currently available therapies typically only addressing secondary defects of diabetes, instead of addressing the underlying cause, the reduced health and function of beta cells. BMF-219 is specifically designed as an oral treatment to potentially retain, restore and regenerate beta cells. This study medication is under investigation for its potential to provide an effective and durable treatment for people with type 2 diabetes following only a limited dosing period. BMF-219 is designed to be potentially complementary to currently

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.