Biomea Fusion, Inc. announced top line data of the 200 mg dose cohorts from the ongoing Phase II clinical study (COVALENT-111) which will be presented in more detail at the International Conference on Advanced Technologies and Treatments of Diabetes (ATTD) in March 2024. At Week 26, 22 weeks after the last dose of a 4-week treatment with BMF-219, approximately 40% of patients from the 200 mg QD cohorts (4/11) displayed durable reduction in HbA1c of 1% or more; effectively near doubling the percentage of patients as compared to 20% observed in the 100 mg QD cohorts (n=20) presented this week at the World Congress Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC). At the ATTD taking place in Florence, March 2024, Biomea will present in an oral poster discussion session, further details of the long-term follow-up data (22 weeks after the last dose of BMF-219) to show durable glycemic control with BMF-219 during the off-treatment period of the 100 mg and 200 mg dose cohorts.

To date, the dose escalation portion has shown, after only 4-weeks of dosing with BMF-219, that patients across all dosing cohorts (n=52) have consistently experienced generally meaningful HbA1c reductions. Patient cohorts at higher dose levels have seen greater pharmacokinetic exposure of BMF-219. Variability seen in HbA1c reduction is viewed as being related to several factors including patients' prior lines of therapies, years since diagnosis, beta cell function scores (Homa-B) and others.

Based on the preclinical data, including the WCIRDC published presentations, the company believes the responses seen to date will improve with longer dose durations and higher dose levels. The best performing dosing cohort announced so far is cohort 3 (100 mg without food, n=10), where the company reported a mean HbA1c reduction of 0.81% after only 4 weeks of dosing. In cohort 3, the company enrolled 90% frontline patients on a single diabetic therapy with a mean HbA1c level reported of 8.1% at baseline; here only 10% of the patients were on two or more therapeutic agents.

The dose cohorts the company enrolled in addition to the 100 mg cohorts (50 mg, 100 mg BID, 200 mg, n=32) had between approximately 30%-100% of patients on two or more background agents, while failing with above normal HbA1c levels (baseline HbA1c ranging from 7.9% to 8.4%). In these cohorts the mean HbA1c reduction was observed between 0.4% to 0.5%, after four weeks of dosing. Considering the consistency of responses, the company believes it confirmed clinically meaningful activity across all dosing cohorts.