Biomea Fusion Reports 52% C-Peptide Increase at Week 12, Adds Rapid Titration to GLP-1 Study
BMEA•Biomea’s Phase II data show 200 mg icovamenib boosted C-peptide AUC by 52% at Week 12 in T1D and preserved Week 52 secretion without immune activation. Translational data showed muscle myotube growth and adipocyte browning; Biomea added a rapid titration cohort to its Phase I BMF-650 oral GLP-1 agonist study.
1. Phase II COVALENT-112 Results
Biomea’s COVALENT-112 study evaluated icovamenib at 100 mg and 200 mg daily in adults with T1D. At Week 12, the 200 mg group achieved a mean 52% increase in C-peptide AUC versus baseline and sustained secretion through Week 52 without systemic immune activation or elevated inflammatory markers, and no new safety signals emerged.
2. Translational Mechanism of Action Findings
In cell models, icovamenib upregulated GLP-1 expression in human colon L-cells and increased GLP-1 receptor levels in islets, promoted myotube size and myosin heavy chain expression in skeletal muscle cells, and induced adipocyte browning with reduced lipid droplet size and elevated glycerol release, indicating potential benefits for metabolic health.
3. Phase I BMF-650 Study Expansion
The company added an extra cohort to its Phase I trial of BMF-650, its oral GLP-1 receptor agonist, to test a rapid one-step titration regimen (200 mg QD for one week followed by 400 mg QD for three weeks) aimed at optimizing dose selection and enhancing weight-loss efficacy.
