On Tuesday, Biomea Fusion Inc. (NASDAQ:BMEA) shared topline results from its ongoing COVALENT-111 study, focusing on the efficacy of icovamenib in patients with type 2 diabetes (T2D). The study involved three dosing arms with a primary follow-up after 26 weeks: Arm A at 100mg QD (once daily) for 8 weeks, Arm B at 100mg QD for 12 weeks, and Arm C at 100 mg QD for 8 weeks and 100mg BID (twice daily) for 4 weeks.
The results at Week 26 were positive, showing statistically significant and clinically meaningful reductions in HbA1c, which is the gold standard for assessing glycemic control in T2D. Patients who were suboptimally controlled at baseline on one or more prior agents demonstrated meaningful reductions in HbA1c across all major categories. Specifically, icovamenib showed a mean reduction in HbA1c of 0.36% (p=0.022), with Arm B (100mg QD for 12 weeks) performing the strongest with a mean HbA1c reduction of 0.5% (p=0.012).
Further analysis revealed that icovamenib provided improved reduction in insulin-deficient patients. Within the mild age-related diabetes (MARD) and severe insulin-deficient diabetes (SIDD) patients, the mean HbA1c reduction was 0.73%, and in Arm B, these patient subtypes reduced the mean HbA1c by 1.05%. The SIDDs, considered the most severely insulin deficient, showed the best response with a mean HbA1c reduction in Arm B of 1.47%. Additionally, patients who failed on a GLP-1-based therapy demonstrated an HbA1c reduction of 0.84%.
The study also noted that icovamenib was well tolerated, with no serious adverse events or discontinuations due to adverse events observed. No drug-to-drug interactions were reported, indicating a favorable safety profile for icovamenib in the COVALENT-111 study.
Despite these promising results, Biomea Fusion's stock (BMEA) was down 14.50% at $5.01 at the last check on Tuesday.
