Biomea Fusion Reports 52% C-Peptide Gain, 1.8% HbA1c Drop and BMF-650 Expansion
BMEA•Biomea Fusion presented data showing icovamenib enhances GLP-1 expression, promotes muscle preservation and induces adipocyte browning. In COVALENT trials, it achieved a 52% C-peptide increase at Week 12 in T1D and a 1.8% placebo-adjusted HbA1c reduction through Week 52 while adding a rapid titration cohort to its BMF-650 study.
1. Translational Data Highlights
Translational data demonstrated that icovamenib increased GLP-1 expression in human colon L-cells and GLP-1 receptor levels in islets, promoted myotube size, myosin heavy chain expression and myoblast fusion in muscle cells, and induced adipocyte browning and lipolysis, supporting complementary metabolic effects beyond glycemic control.
2. Type 1 Diabetes COVALENT-112 Results
In the 52-week COVALENT-112 study in adults with type 1 diabetes, 200 mg daily icovamenib increased C-peptide AUC by 52% at Week 12 versus baseline and preserved C-peptide levels within 7% of baseline at Week 52, compared with historical annual declines of 47%; no systemic immune activation or new safety signals were observed.
3. Type 2 Diabetes COVALENT-111 Outcome
Subgroup analysis from the COVALENT-111 trial in type 2 diabetes patients on background GLP-1 RA therapy showed a 1.2% mean HbA1c reduction at Week 52 versus a 0.6% increase with placebo, yielding a 1.8% placebo-adjusted improvement and durable glycemic benefits through 40 weeks post-treatment.
4. BMF-650 Phase I Cohort Expansion
The Phase I BMF-650 study was expanded with an additional cohort evaluating a one-step titration of 200 mg once daily for one week followed by 400 mg once daily for three weeks to assess rapid dose escalation and enhanced weight loss potential of the oral GLP-1 receptor agonist.
