Biomea Fusion presents data from initial cohorts of Phase II study of BMF-219

Biomea Fusion announced the presentation of new clinical data from the first two cohorts of patients with T2D enrolled in the Phase II portion of its ongoing Phase I/II clinical study, COVALENT-111, of BMF-219, the company’s investigational oral covalent menin inhibitor. 40 patients were enrolled in the first three Multiple Ascending Dose cohorts of COVALENT-111, with the first cohor comprising 16 healthy volunteers; 12 HVs received 100 mg of BMF-219 once daily and 4 HVs received placebo QD for two weeks and thereafter followed off treatment for an additional six weeks. In Cohorts 2 and 3, T2D patients were treated for four weeks with or without food, respectively, and then followed for 22 weeks after treatment. In these two treatment cohorts, enrolled patients had T2D diagnosed for less than 15 years, were between the ages of 18 to 65, had been treated with lifestyle management with or without up to three standard-of-care anti-diabetic medications, excluding sulfonylureas and insulin, with a stable dosing regimen for at least two months prior to screening, had a BMI greater than or equal to 25 and less than or equal to 40 kg/m2, and had poorly controlled diabetes. At baseline, diabetic patients in Cohorts 2 and 3, had a mean HbA1c of 8.0% and 8.1%, respectively. As reported in March 2023, during the 4-week dosing period BMF-219 was generally well tolerated; all patients completed the treatment, and all patients continue to be in follow-up to assess the durability of the treatment effect. There were no dose reductions, dose discontinuations, or severe or serious adverse events. No patients showed symptomatic hypoglycemia, significant changes in hemoglobin levels, or other TEAEs. During the off-treatment period, no severe or serious TEAEs were noted. Dosing of patients in the 200 mg without food cohort was recently completed and is now in the follow-up period. The 200 mg with food cohort led to an increase in mild to moderate nausea compared to 200 mg without food. This cohort will be transitioned to 100 mg BID dosing. No other clinical symptoms or clinical concerns were observed in this dose level. In the HV Cohort 1, 2 of 12 patients treated with BMF-219 and 1 of 4 patients treated with placebo showed mild TEAEs. No other TEAEs were observed.