Biomea Fusion presents BMF-219 data from escalation phase of COVALENT-111 trial

Biomea Fusion announced three poster presentations presenting long-term 26 week follow-up data from patients treated with BMF-219, enrolled in the escalation portion of the ongoing Phase II clinical study, at the 17th International Conference on Advanced Technologies & Treatments for Diabetes, or ATTD, taking place in Florence, Italy from March 6-9. This clinical data from all dosing cohorts initiated to date as of February 12 from the Escalation Phase of COVALENT-111 will be featured during a poster discussion presentation and two poster viewing presentations at ATTD. Biomea will showcase the following three e-poster presentations: Durable Glycemic Control with BMF-219 During Off-Treatment Period at Week 26: A Phase 1/2 Trial of BMF-219 in Patients with Type 2 Diabetes. Case Studies from COVALENT-111, A Phase 1/2 Trial of BMF-219, a Covalent Menin Inhibitor, in Patients with Type 2 Diabetes. Key Observations from the Dose Escalation Portion of COVALENT-111, a Phase 1/2 Trial of the Covalent Menin Inhibitor BMF-219 in Patients with Type 2 Diabetes (Poster Viewing Session. Patients in COVALENT-111 are displaying improved glycemic control while off therapy, supporting improved pancreatic function following BMF-219 treatment. Patients who demonstrated the greatest HbA1c reduction at Week 26, had the greatest improvement in beta cell function as measured by HOMA-B and C-peptide. In patients failing current standard of care medications, at Week 26, following a 28 day dose cycle of BMF-219, a general dose response was observed with placebo adjusted mean percent changes of HbA1c of -0.04%, -0.2%, -0.8%, -0.4%, -0.4% and -1.4%. The efficacy seen in the 200mg with food cohort is highlighting the direct benefits of an enhanced PD effect with higher blood glucose and higher exposure, as seen in the human islet studies with BMF-219. A higher proportion of patients treated with 200mg QD achieved a clinically significant reduction in HbA1c compared to 100mg QD dosing. A durable glycemic response was seen in 20% and 36% of patients in once daily 100 mg and 200 mg cohorts, respectively. Across 100mg QD, 200mg QD, and 100mg BID cohorts, 38% of patients had greater than or equal to 0.5% HbA1c reduction, and 23% of patients had greater than or equal to 1% HbA1c reduction at Week 26. Patients with greater than seven years duration of diabetes and failing dual- or triple-agent therapy also demonstrated improved glycemic control with BMF-219 dosed at 200mg with food. Increase in HOMA-B and C-peptide generally correlated with glycemic control, consistent with BMF-219’s core mechanism of action: beta-cell proliferation and improved beta-cell function. BMF-219 was generally well tolerated with no serious adverse events and no adverse event-related study discontinuations, and no symptomatic or clinically significant hypoglycemia. The expansion Phase of COVALENT-111 is designed to further explore BMF-219’s potential for long-term glycemic control by dosing BMF-219 for up to 12 weeks at various dosing levels with follow-up of 26 and 52 weeks. The expansion phase is currently enrolling on schedule with initial data expected in the second half of 2024. A PK study further assessing the optimal use of BMF-219 to ensure minimal variability of exposure is currently under way. Biomea is currently awaiting the read out and analysis of an additional 400 mg cohort, which will also help inform further inclusion into the Expansion Phase.