Biomea Fusion's Diabetes Drug BMF-219 Placed on Clinical Hold

REDWOOD CITY, Calif. – Biomea Fusion(Nasdaq: BMEA), a clinical-stage biopharmaceutical company, announced on June 6, 2024, that the U.S. Food and Drug Administration (FDA) has placed a full clinical hold on its ongoing Phase I/II trials for the investigational covalent menin inhibitor, BMF-219. These trials, COVALENT-111 and COVALENT-112, are focused on evaluating the drug's efficacy and safety in treating type 2 and type 1 diabetes, respectively. Despite the hold, Biomea Fusion will continue to collect safety and efficacy data.

Thomas Butler, CEO and Chairman of Biomea Fusion, emphasized the company's commitment to patient safety and their collaboration with the FDA to resolve the issues quickly. Butler highlighted that the data so far suggests that BMF-219 is generally well-tolerated and has potential benefits in restoring insulin production and improving blood sugar control. He reaffirmed the company's dedication to advancing BMF-219 due to its promising profile.

The FDA's decision was influenced by potential liver toxicity observed during the Dose Escalation Phase of COVALENT-111. Factors such as higher doses, varying food intake regimens, and patients' medical histories might have contributed to increased liver enzyme levels. Nevertheless, most adverse events reported in both COVALENT-111 and COVALENT-112 have been mild to moderate, with no serious adverse reactions to date.

COVALENT-111 Trial Details

COVALENT-111 is a multi-site, randomized, double-blind, placebo-controlled study. The Phase I portion, now completed, involved healthy participants receiving single ascending doses to determine safety for type 2 diabetes patients. In Phase II, the study involves multiple ascending dose cohorts of adult patients with type 2 diabetes not adequately controlled by standard medications. After completing the Dose Escalation Phase, the study moved into an Expansion Phase, focusing on longer dose durations. For further details, the trial is registered on ClinicalTrials.gov under the identifier NCT05731544.

COVALENT-112 Trial Overview

COVALENT-112 is also a multi-site, randomized, double-blind, placebo-controlled Phase II study, but it targets adults with stage 3 type 1 diabetes. This stage is characterized by significant beta cell loss and noticeable symptoms. The trial will compare two different doses of BMF-219 to placebo in a 1:1:1 ratio to assess the drug's efficacy, safety, and durability. Approximately 150 patients will participate, each receiving treatment for 12 weeks followed by a 40-week off-treatment period. An open-label portion of the trial will involve up to 40 adults diagnosed with type 1 diabetes within the last 15 years, receiving either 100 mg or 200 mg doses of BMF-219 for 12 weeks, followed by 40 weeks off-treatment. Additional details can be found on ClinicalTrials.gov with the identifier NCT06152042.

About Biomea Fusion

Biomea Fusion is a clinical-stage biopharmaceutical company that focuses on discovering and developing oral covalent small molecules for treating metabolic diseases and genetically defined cancers. These molecules form permanent bonds with their target proteins, providing potential advantages like greater selectivity, lower drug exposure, and more durable responses. The company's proprietary FUSION™ System aids in designing a pipeline of next-generation covalent-binding small molecule medicines, aiming to significantly impact disease treatment.

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