Core Insights - Chemomab Therapeutics Ltd. announced positive results from its Phase 2 SPRING trial for CM-101 in patients with primary sclerosing cholangitis (PSC), demonstrating anti-fibrotic, anti-inflammatory, and anti-cholestatic activity [1][5][6] Study Details - The Phase 2 SPRING trial involved 76 PSC patients receiving two doses of CM-101 (10 mg/kg and 20 mg/kg) every three weeks for 15 weeks [3] - The trial included a double-blinded, placebo-controlled design, focusing on patients who completed all doses and the week 15 visit [2][3] Efficacy and Safety - CM-101 met its primary endpoint with a favorable safety profile, showing mild to moderate adverse events similar to the placebo group [4] - Significant improvements were observed in liver stiffness, ELF scores, PRO-C3 levels, liver biochemistries, total bilirubin levels, and pruritus scores in CM-101 treated patients compared to placebo [4][5] Future Development - Chemomab plans to advance CM-101 into a registrational trial and expects to meet with the FDA by the end of 2024 to discuss the trial design [6][7] - An open-label extension of the Phase 2 SPRING trial is ongoing, with results anticipated in the first quarter of 2025 [7] Company Background - Chemomab is a clinical-stage biotechnology company focused on developing therapeutics for fibroinflammatory diseases, with CM-101 being a first-in-class monoclonal antibody targeting CCL24 [9] - The company has received FDA and EMA Orphan Drug designations and FDA Fast Track status for CM-101 in PSC [9]
Oral Presentation at AASLD The Liver Meeting® 2024 Highlights Broad Clinical Activity of Chemomab's CM-101 Across Multiple Biomarkers and Its Disease-Modifying Potential in Primary Sclerosing Cholangitis