FDA Resumes BMF-219 Diabetes Trials

Biomea Fusion, Inc., a clinical-stage biopharmaceutical company based in Redwood City, California, has announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on their ongoing Phase I/II trials of the investigational menin inhibitor BMF-219 for type 2 and type 1 diabetes (COVALENT-111 and COVALENT-112, respectively).

Thomas Butler, the Chief Executive Officer and Chairman of the Board of Biomea Fusion, expressed gratitude for the FDA's swift review of their data, which reaffirmed their confidence in BMF-219 as a novel agent for diabetes treatment. Butler noted that the safety review of the ongoing Phase 2b Expansion Study was encouraging, especially since concerning safety signals observed in the Phase 2a Escalation Study were not present in the larger Expansion Study. Importantly, none of the elevated lab values translated to confirmed serious liver injury or impairment.

Biomea Fusion plans to continue their robust development plan for BMF-219, as the resumption of their ongoing studies, COVALENT-111 and COVALENT-112, is now fully underway.

The company also shared details about an upcoming webcast for investor updates, set to take place on Thursday, September 26th. The webcast will be available to registered attendees under the Investors and Media section of Biomea's website, with a replay archived following the event.

For the fourth quarter of 2024, Biomea Fusion anticipates several key milestones in their diabetes program:
- The announcement of a third development candidate, a potent, selective, oral small molecule GLP-1 receptor agonist.
- The topline Week 26 data readout of Phase 2b with around 200 patients of COVALENT-111.
- The topline data readout of Phase 2a of COVALENT-112 with approximately 20 patients.

COVALENT-111 is designed as a multi-site, randomized, double-blind, placebo-controlled Phase I/II study. The completed Phase I portion involved healthy patients in single ascending dose cohorts to evaluate safety at the prospective dosing levels for type 2 diabetic patients. Phase II consists of multiple ascending dose cohorts and includes adult patients with type 2 diabetes uncontrolled by standard care medicines. After completing the Escalation Phase, the study moved into an Expansion Phase (Phase IIb) involving multiple cohorts dosing type 2 diabetes patients for longer durations. More information about this trial can be found using ClinicalTrials.gov identifier NCT05731544.

COVALENT-112 is a multi-site, randomized, double-blind, placebo-controlled Phase II study in adults with stage 3 type 1 diabetes, characterized by significant beta cell loss. The trial will compare two different doses of BMF-219 to a placebo (1:1:1) to evaluate efficacy, safety, and durability. Approximately 150 patients will be enrolled, receiving either BMF-219 or a placebo over 12 weeks, followed by a 40-week off-treatment period. An open-label portion also examines the efficacy, safety, and durability of BMF-219 at two oral dose levels (100 mg and 200 mg) over a 12-week treatment period, followed by a 40-week off-treatment period. Additional details about this trial are available using ClinicalTrials.gov identifier NCT06152042.

Biomea Fusion is focused on the discovery and development of oral covalent small molecules for treating metabolic diseases and genetically defined cancers. Their proprietary FUSION™ System is utilized to discover, design, and develop a pipeline of next-generation covalent-binding small molecule medicines aimed at maximizing clinical benefit for patients.