Biomea Fusion’s Menin Inhibitor Shows Durable A1C Declines; Oral GLP-1 Achieves 15% Monkey Weight Loss
Biomea Fusion’s menin inhibitor icovamenib yielded continued A1C declines for months after a three-month dosing period in a severe insulin-deficient type 2 diabetes subgroup from its COVALENT-111 study, prompting FDA filings for two follow-on trials (COVALENT-211 and COVALENT-212). Its oral GLP-1 candidate BMF-650 achieved 12–15% weight loss over 28 days in monkey studies, with human weight-loss data expected around mid-year.
1. Durable A1C Improvement in COVALENT-111
In the COVALENT-111 trial, severe insulin-deficient type 2 diabetes patients received oral icovamenib for three months and experienced continued declines in A1C for several months after dosing ended, demonstrating a durable effect beyond the treatment window.
2. FDA Filings for Follow-On Studies
Biomea Fusion has filed two follow-on trials with the FDA: COVALENT-211 will enroll 60 adult type 2 diabetes patients on 1–3 anti-diabetic medications (A1C 7.5–10.5, BMI ≤32) to evaluate six-month A1C, while COVALENT-212 targets inadequately controlled patients on GLP-1 regimens (A1C 7.5–9.5, BMI 25–40) to assess combination therapy.
3. BMF-650 Preclinical Weight Loss Data
The company’s oral GLP-1 receptor agonist BMF-650 reduced food intake and body weight by approximately 12–15% over 28 days in a multiple-ascending-dose monkey study, with no liver function abnormalities observed and a favorable safety profile noted.
4. Upcoming Clinical Milestones and Timelines
Biomea expects to initiate patient screening for its follow-on studies shortly, reaching primary endpoints by year-end, and aims to report human weight-loss data for BMF-650 around mid-year, with Phase I dose-escalation ongoing.