Biomea Fusion Announces 52-Week Phase II Data For Icovamenib In Type 2 Diabetes; Study Shows Sustained HbA1c Reduction And Favorable Safety Profile

Author: Benzinga Newsdesk | October 06, 2025 03:04pm

• Icovamenib showed a sustained treatment benefit at Week 52 (9 months past the end of treatment) in the severe insulin-deficient diabetes patient population taking one or more antihyperglycemic medications at baseline, with a 1.8% placebo adjusted mean reduction in HbA1c (Arm B)
• Type 2 diabetes patients on a GLP-1-based therapy failing to achieve their target HbA1c also showed a clinically meaningful response from only 12 weeks of icovamenib treatment with a mean placebo adjusted HbA1c reduction of 1.8% (Arms A, B, and C combined) at Week 52
• Icovamenib was generally well tolerated across all dosing arms and demonstrated a favorable safety and tolerability profile through Week 52
• Phase II trials in severe insulin-deficient diabetes patients and diabetes patients not achieving glycemic target with a GLP-1-based therapy are expected to begin in the fourth quarter of 2025
• Company to host a conference call to discuss results on Tuesday, October 7 at 8:30 am ET
  
   

SAN CARLOS, Calif., Oct. 06, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea" or "Biomea Fusion" or "the Company") (NASDAQ:BMEA), a clinical-stage diabetes and obesity company, today announced positive 52-week results from its Phase II COVALENT-111 study evaluating the efficacy, safety, and tolerability of icovamenib in patients with type 2 diabetes (T2D).

Posted In: BMEA