Biomea Fusion, Inc. (BMEA), a clinical-stage diabetes and obesity company, announced positive 52-week results from its Phase 2 COVALENT-112 trial evaluating Icovamenib in patients with type 1 diabetes or T1D.
Icovamenib is an orally administered investigational small molecule currently in Phase 2 clinical development for the treatment of diabetes. Trial details
COVALENT-112 was an open-label Phase 2 trial evaluating Icovamenib in adult patients with T1D.
The study enrolled patients aged 18 to 60 years with Stage 3 T1 Diabetes, including those diagnosed within 0-3 years and with baseline residual beta-cell function.
The primary endpoint was the mean change from baseline in stimulated C-peptide area under the curve (AUC), measured during a mixed-meal tolerance test (MMTT), to evaluate endogenous insulin secretion.
Secondary endpoints included additional measures of beta-cell function, glycemic control, insulin use, and safety.
Key Findings
In patients diagnosed within 0-3 years, treatment with Icovamenib 200 mg once daily for 12 weeks resulted in a 52% increase in mean C-peptide area under the curve (AUC) at Week 12.
Notably, Mean C-peptide AUC was largely preserved through Week 52, representing approximately a 7% decline from baseline.
Also, the 200 mg dose demonstrated greater activity than the 100 mg dose.In patients with longer-standing disease (3-15 years since diagnosis), C-peptide levels were generally preserved through Week 52 (12-week treatment period + 40-week follow-up), with only a modest decline from baseline.
According to the firm, Icovamenib was generally well tolerated, with no new or unexpected safety signals identified throughout the 52-week observation period. What's Ahead?
A comprehensive data set will be presented at the upcoming American Diabetes Association's (ADA) Scientific Sessions in June.
Biomea, in collaboration, plans to initiate a Phase 2 trial in the second half of 2026 in patients with T1D diagnosed within the past 3 years.
The study will evaluate whether extended dosing of 200 mg for 6 or 12 months further improves C-peptide levels and whether the addition of an immunosuppressive agent enhances clinical outcomes.
BMEA has traded between $0.87 and $3.08 over the last year. The stock closed Monday's trade at $1.73, down 8.47%.
In the overnight market, BMEA is down $1.73% at $1.70.
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