The FDA has cleared an investigational drug application for BMF-219, a covalent menin inhibitor drug being developed as a preventative for type 2 diabetes, the drug’s developer recently announced in a press release. 

As loss of functional beta cell mass is a contributing factor for progression of both type 1 and type 2 diabetes, and menin is hypothesized to affect beta cell turnover and growth over time, BMF-219 is being examined as a preventative treatment for type 2 diabetes as a menin inhibitor drug, the company said. 

“We are excited to now clinically evaluate the impact that we have observed with BMF-219 in preclinical studies on the health of beta cells, which is critical to enabling patients with diabetes to naturally produce insulin. In animal models, BMF-219 has shown a very unique profile in preserving, reactivating and regenerating beta cells,” Steve Morris, MD, chief medical officer at Biomea Fusion, stated in the press release. “During my 40 years in medicine, I have not seen a more direct and elegant approach to addressing this root cause of diabetes.”  

BMF-219 has been evaluated in the phase 1/2 randomized, double-blinded, placebo-controlled COVALENT-111 trial, with phase 1 enrolling 40 healthy patients who received a single ascending dose of oral BMF-219 at doses of 100 mg, 200 mg, 400 mg, and 600 mg for 28 days to assess safety and tolerability, according to data shown at a conference call following the announcement. The results showed the drug was well tolerated and had a favorable pharmacokinetic and pharmacodynamic profile. In phase 2 of the COVALENT-111, the manufacturer intends to enroll patients with type 2 diabetes in multiple ascending dose cohorts to assess long-term glycemic control among patients with uncontrolled diabetes. The phase 2 trial is expected to start in the first half of 2023 

“With this [investigational drug application] clearance for BMF-219, we have reached another critical milestone in our pursuit of providing an important new medicine to diabetes patients that addresses the underlying disease physiology. COVALENT-111 is a historic study, representing the first clinical evaluation of an orally administered, covalent small molecule directly targeting menin, a well-known regulator of beta cell homeostasis,” Thomas Butler, Biomea’s CEO and chairman of the board, stated in the press release. “I would like to thank all involved for their considerable guidance and collaboration throughout the preparation and submission of this application. I would also like to especially thank TEAM FUSION for their commitment and support in generating the first non-oncology [investigational drug application] package for BMF-219 in the US.” 

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Disclosures: Morris and Butler are employees of Biomea Fusion. COVALENT-111 is being supported by Biomea Fusion. 

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