Biomea Fusion: Near Doubling of Durable HbA1c Reduction in Diabetes Dose Cohorts

• At Week 26, 22 weeks after the last dose of BMF-219, the 200 mg cohorts increased the percentage of patients to approximately 40% with durable HbA1c reduction of 1% or more as compared to the 100 mg cohorts which reported earlier as 20%.
• To date, the dose escalation portion has shown after only 4 weeks of dosing with BMF-219 that patients across all dosing cohorts have consistently experienced generally meaningful HbA1c reductions and no serious adverse events or study discontinuations.

Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, today 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 WCIRDC over the past days, we had the opportunity to lay out the foundational preclinical work and the data sets which supported that beta cell proliferation and their functional improvement is tractable to BMF-219, not only in animals, but also in the human islets, which we studied together with the Harvard Medical School, Joslin Diabetes Center. When inhibiting menin covalently, we observed some of the key signaling pathways and genes that are known to influence beta cell proliferation and function. As presented at the conference, we have shown for the first time the long-term follow-up data of our 100 mg patient cohorts. At ATTD next March, we will further discuss the long-term follow-up data from the 200 mg cohorts,” said Thomas Butler, Biomea Fusion’s Chief Executive Officer and Chairman of the Board. “Today, we can confidently say that we are specifically proliferating beta cells in pancreatic islets. By increasing the dose from 100 mg to 200 mg, we are excited about nearly doubling the percentage of patients treated with BMF-219 having a robust HbA1c reduction of 1% or more, 22 weeks after the last dose. We are now methodically going through the kinetics and durability of the responses that we have seen to better understand how we can support the various patients, and in particular those that have failed to reach their target HbA1c while on multiple agents including GLP-1s. Our goal with BMF-219 is to create a short-term treatment regimen for patients with diabetes that results in long term glycemic improvement and control. We believe we have made significant progress in reaching this goal, as reported over the past few days, and we look forward to further updates in 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, we believe 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 we reported a mean HbA1c reduction of 0.81% after only 4 weeks of dosing. In cohort 3, we 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 we 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 our responses, we believe we have confirmed clinically meaningful activity across all dosing cohorts.

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