Biomea Fusion Announces Positive Topline Results from COVALENT-111 Clinical Trial

Biomea Fusion, Inc., a Delaware-based biopharmaceutical company (NASDAQ:BMEA), made a significant disclosure on December 17, 2024, regarding topline data from the Phase II portion of its COVALENT-111 clinical trial involving their lead product candidate, icovamenib, for the treatment of type 2 diabetes (T2D).

The company reported that icovamenib met the primary endpoint in the Phase II trial, showing a notable statistically significant reduction in HbA1c levels at Week 26 compared to placebo. Particularly, patients in Arm B, comprising a larger patient set from the two 12-week dosing arms, displayed a significant reduction in HbA1c compared to placebo across all patients in the Per Protocol Patient population. Results from a post-hoc analysis further showed that patients on icovamenib, especially in Arm B, demonstrated a significant reduction in HbA1c compared to placebo, with the most substantial response observed in beta-cell deficient patients on antidiabetic agents at baseline.

During the 12-week dosing period, icovamenib was well-tolerated, with no adverse-event related discontinuations, hypoglycemic events, or serious adverse events reported. The COVALENT-111 trial aims to determine the optimal dose and patient subgroup for advancing icovamenib in late-stage clinical development.

Based on these promising outcomes, Biomea Fusion plans to engage with the U.S. Food and Drug Administration (FDA) for discussions on further advancing icovamenib as a first-in-class menin inhibitor therapy for T2D. Additionally, the company anticipates a 52-week readout in the second half of 2025.

It should be noted that forward-looking statements are inherent in this announcement, subject to risks and uncertainties outlined in Biomea Fusion’s recent SEC filings. The company disclaims any obligation to update these forward-looking statements, except as required by law.

The company also provided key details from the COVALENT-111 trial through exhibits attached to their Form 8-K filing, including a press release and a corporate presentation outlining the study’s findings.

The positive results from the COVALENT-111 trial mark a significant milestone for Biomea Fusion as it advances its innovative treatment approaches for type 2 diabetes. Investors are keenly observing the company’s progress as it moves closer to potential regulatory discussions and further clinical development milestones.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Biomea Fusion’s 8K filing here.

Biomea Fusion Company Profile

Biomea Fusion, Inc, a clinical-stage biopharmaceutical company, focuses on the discovery and development of covalent small molecule drugs to treat patients with genetically defined cancers and metabolic diseases. Its lead product candidate is BMF-219, a covalent inhibitor of menin for treating patients with liquid and solid tumors and type 2 diabetes.