Biomea Fusion to Present BMF-219 Diabetes Trial Data at ATTD-ASIA 2024
核心洞察
Biomea Fusion will present data from its COVALENT-111 and COVALENT-112 trials at the ATTD-ASIA 2024 conference in Singapore.
The presentations will include Phase II study designs for BMF-219 in type 2 and type 1 diabetes (搜索) patients.
Case studies assessing BMF-219 in patients with poorly controlled severe insulin-deficient type 2 diabetes (搜索) will also be highlighted.
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 (搜索) Management (ATTD-ASIA 2024), held in Singapore from November 18-20, 2024. The presentations will feature the company's investigational oral covalent menin (搜索) inhibitor, BMF-219, in both type 2 and type 1 diabetes (搜索) 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 (搜索) 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 (搜索). 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 (搜索) 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 (搜索), obesity (搜索), and genetically defined cancers.