On Tuesday, Biomea Fusion Inc. (NASDAQ:BMEA) revealed topline results from the ongoing COVALENT-111 study of icovamenib in patients with type 2 diabetes (T2D).
Icovamenib was investigated in three different 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.
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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.
Patients who completed dosing per the protocol and were suboptimally controlled at baseline on one or more prior agents, icovamenib, showed meaningful reductions in HbA1c with statistical significance in all major categories.
Here, icovamenib showed a mean reduction in HbA1c of 0.36% (p=0.022). Arm B (icovamenib dosed at 100mg QD for 12 weeks) was the strongest performing arm with a mean HbA1c reduction of 0.5% (p=0.012).
In the analysis of the T2D phenotypes, icovamenib showed further 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 patients who were considered most severely insulin deficient, the SIDDs, demonstrated the best response with a mean HbA1c reduction in Arm B of 1.47%.
Of note, in the patients who failed on a GLP-1-based therapy, an HbA1c reduction of 0.84% was demonstrated.
No serious adverse events or discontinuations due to adverse events were observed.
No drug-to-drug interactions were observed during the study. Overall, icovamenib was well tolerated and demonstrated a favorable safety profile in the COVALENT-111 study.
Price Action: BMEA stock is down 14.50% at $5.01 at the last check on Tuesday.
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