Biomea Fusion, Inc. will present data from its COVALENT-111 and COVALENT-112 clinical trials at the 1st Asian Conference on Innovative Therapies for Diabetes Management (ATTD-ASIA 2024), held in Singapore from November 18-20, 2024. The presentations will feature the company's investigational oral covalent menin inhibitor, BMF-219, in both type 2 and type 1 diabetes patients.
Presentations Overview
Juan P. Frias will present the data, which includes a long oral presentation and two short oral presentations. The accepted abstract titles are:
- COVALENT-111: A Phase 2 Trial of the Oral Menin Inhibitor BMF-219 in Patients with Type 2 Diabetes (Short Oral Presentation on Tue, 11/19/24)
- Assessment of BMF-219 in Persons with Poorly Controlled Severe Insulin-Deficient (SIDD) Type 2 Diabetes (T2D): COVALENT-111 Case Studies (Short Oral Late Breaker Presentation on Tue, 11/19/24)
- COVALENT-112: A Phase 2 Trial of the Oral Menin Inhibitor BMF-219 in Type 1 Diabetes (Long Oral Presentation on Wed, 11/20/24)
COVALENT-111 Trial Details
COVALENT-111 is a Phase I/II multi-site, randomized, double-blind, placebo-controlled study. The Phase I portion evaluated the safety of BMF-219 in healthy patients using single ascending doses. The Phase II portion includes adult patients with type 2 diabetes uncontrolled by standard of care medicines, using multiple ascending dose cohorts. The study advanced into an Expansion Phase, dosing type 2 diabetes patients for up to 12 weeks with BMF-219 or placebo, followed by a 40-week off-treatment period. Approximately 200 patients completed their respective dosing period before the FDA placed the study on hold. The trial is registered under ClinicalTrials.gov identifier NCT05731544.
COVALENT-112 Trial Details
COVALENT-112 is a Phase II multi-site, randomized, double-blind, placebo-controlled study in adults with stage 3 type 1 diabetes. The trial compares two different doses of BMF-219 to placebo to evaluate efficacy, safety, and durability. Approximately 150 patients will receive BMF-219 or placebo over 12 weeks, followed by a 40-week off-treatment period. An open-label portion includes adults with type 1 diabetes up to 15 years since diagnosis, examining two oral dose levels (100 mg and 200 mg) over a 12-week treatment period followed by a 40-week off-treatment period (n=40). Approximately 20 patients completed 8 weeks of dosing in the open-label portion before the FDA hold. The trial is registered under ClinicalTrials.gov identifier NCT06152042.
About BMF-219
BMF-219 is an investigational oral covalent menin inhibitor developed to regenerate insulin-producing beta cells. Biomea Fusion is dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with diabetes, obesity, and genetically defined cancers.
