Chemomab Therapeutics announces Phase 2 trial results for CM-101

Chemomab Therapeutics reported positive topline results from the Phase 2 SPRING trial assessing its first-in-class monoclonal antibody, CM-101, in patients with primary sclerosing cholangitis, PSC. Treatment with CM-101 achieved its primary endpoint of safety and tolerability and demonstrated anti-fibrotic, anti-inflammatory and anti-cholestatic effects across a broad range of disease-related secondary efficacy endpoints, including statistically significant improvement in liver stiffness, a key PSC disease marker. CM-101 SPRING Trial – Overview of Key Results: CM-101 met the primary study endpoint, demonstrating a favorable safety profile over the 15-week treatment period. CM-101-treated patients with moderate/advanced disease showed improvements on a wide range of disease-related secondary endpoints, including assessments of changes from baseline relative to placebo at Week 15 in liver stiffness; in liver fibrosis biomarkers, including the Enhanced Liver Fibrosis score and PRO-C3 levels; in total bilirubin and liver function tests; in pruritis and in markers of inflammation. Dose-dependent responses were observed for multiple disease-related biomarkers. CM-101 in PSC Patients: Chemomab is preparing for an End-of-Phase 2 meeting with the FDA to discuss the SPRING trial results and the design of a proposed Phase 3 PSC trial for accelerated approval. The company anticipates completing these discussions by the end of the year and receiving official written feedback from the FDA in the first quarter of 2025. An Open Label Extension portion of the SPRING trial, which offers patients the opportunity to receive CM-101 for an additional 33-weeks, is ongoing. CM-101’s novel CCL24 target has been of interest to potential partners for several years. The company intends to further explore opportunities to collaborate with strategic partners in light of the positive topline data reported from the SPRING trial.