Biomea Fusion announces results from ongoing COVALENT-111 study

Biomea Fusion (BMEA) announced positive topline results from the ongoing COVALENT-111 study, evaluating the efficacy, safety and tolerability of icovamenib in patients with type 2 diabetes, T2D. The study showed positive topline results at Week 26, demonstrating statistically significant and clinically meaningful reductions in HbA1c, the gold standard for assessing glycemic control in T2D. In patients who completed dosing per protocol and were suboptimally controlled at baseline on one or more prior agent, icovamenib showed meaningful reductions in HbA1c with statistical significance in all major categories. Here icovamenib showed a mean reduction in HbA1c of 0.36%. The strongest performing arm was Arm B with a mean HbA1c reduction of 0.5%. In the analysis of the T2D phenotypes, icovamenib showed further improved reduction in the insulin deficient patients. Within the mild age-related diabete and severe insulin-deficient diabetes patients the mean HbA1c reduction was 0.73% and in Arm B these patient subtypes reduced the mean HbA1c by 1.05%. Patients who were considered most severe insulin deficient, the SIDDs, demonstrated the best response with a mean HbA1c reduction in Arm B of 1.47%. Importantly, MARD and SIDD represent more than 50% of the US patient population. Of note, in the patients that failed on a GLP-1 based therapy an HbA1c reduction of 0.84% was demonstrated.