From GlobeNewswire:

Biomea Fusion, Inc. is set to release the expansion portion of Phase II of the COVALENT-111 study in 2024. This study involves 216 patients with type 2 diabetes and aims to evaluate the efficacy of BMF-219 for 12 weeks. They also expect to read out the open label portion of the Phase II COVALENT-112 study in 40 patients with type 1 diabetes in 2024.

According to Thomas Butler, the Chief Executive Officer and Chairman of the Board at Biomea Fusion, the company had a successful 2023. They obtained positive data readouts for type 2 diabetes and Acute Myeloid Leukemia (AML), and progress in their second pipeline asset BMF-500. “BMF-219 has the potential to address the root cause of diabetes,” stated Butler, referring to their goals for the new year.

BMF-219, a covalent small molecule, showed promising results in the Phase II trial for type 2 diabetes. 84% of patients showed a reduction in HbA1c after 4 weeks of dosing, and 60% achieved controlled HbA1c at the end of the study. The FDA and Health Canada approved the expansion portion of the study in 216 patients, with data expected to be presented in March 2024.

The Phase II COVALENT-112 study for type 1 diabetes was also cleared by the FDA and Health Canada. The trial expects to enroll 150 adults and examine the safety and efficacy of BMF-219 at two oral dose levels for 12 weeks, followed by a 40-week off-treatment phase. The study also plans to include an open label portion with 40 participants.

In oncology, Biomea continued patient enrollment exploring the utility of BMF-219’s in liquid and solid tumors. They anticipate completing dose escalation studies and establishing recommended Phase II doses for the various COVALENT trials in oncology.

Biomea is utilizing the proprietary FUSION™ System to progress their in-house research efforts. They are expected to announce a third development candidate from the FUSION System in 2024. Their website is available for more information on their research and development programs.



Read more: Biomea Fusion Highlights Recent Updates and Anticipated