On Tuesday, Biomea Fusion Inc. BMEA revealed topline outcomes from the continued COVALENT-111 research of icovamenib in sufferers with sort 2 diabetes (T2D).
Icovamenib was investigated in three completely different dosing arms with a main follow-up after 26 weeks: Arm A at 100mg QD (as soon as each day) 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 each day) for 4 weeks.
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The research confirmed constructive topline outcomes at Week 26, demonstrating statistically vital and clinically significant reductions in HbA1c, the gold customary for assessing glycemic management in T2D.
Sufferers who accomplished dosing per the protocol and had been suboptimally managed at baseline on a number of prior brokers, icovamenib, confirmed significant reductions in HbA1c with statistical significance in all main classes.
Right here, icovamenib confirmed a imply discount 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 imply HbA1c discount of 0.5% (p=0.012).
Within the evaluation of the T2D phenotypes, icovamenib confirmed additional improved discount in insulin-deficient sufferers.
Inside the gentle age-related diabetes (MARD) and extreme insulin-deficient diabetes (SIDD) sufferers, the imply HbA1c discount was 0.73%, and in Arm B, these affected person subtypes lowered the imply HbA1c by 1.05%.
The sufferers who had been thought of most severely insulin poor, the SIDDs, demonstrated the very best response with a imply HbA1c discount in Arm B of 1.47%.
Of observe, within the sufferers who failed on a GLP-1-based remedy, an HbA1c discount of 0.84% was demonstrated.
No severe adversarial occasions or discontinuations on account of adversarial occasions had been noticed.
No drug-to-drug interactions had been noticed throughout the research. General, icovamenib was nicely tolerated and demonstrated a good security profile within the COVALENT-111 research.
Value Motion: BMEA inventory is down 14.50% at $5.01 on the final examine on Tuesday.
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