Chemomab Therapeutics Announces Positive Phase 2 Trial Results: CM-101 Achieves Primary and Secondary Endpoints Demonstrating Anti-Fibrotic, Anti-Inflammatory and Anti-Cholestatic Effects in Patients with Primary Sclerosing Cholangitis

Core Insights - Chemomab Therapeutics reported positive topline results from the Phase 2 SPRING trial for its monoclonal antibody CM-101 in patients with primary sclerosing cholangitis (PSC), achieving its primary endpoint of safety and tolerability while demonstrating significant anti-fibrotic, anti-inflammatory, and anti-cholestatic effects [2][3][5] Company Overview - Chemomab is a clinical-stage biotechnology company focused on developing innovative therapeutics for fibro-inflammatory diseases with high unmet medical needs, particularly targeting CCL24 to address fibrosis and inflammation [26] Clinical Trial Results - The Phase 2 SPRING trial involved 76 patients treated with either 10 mg/kg or 20 mg/kg of CM-101 every three weeks over 15 weeks, with a focus on safety and a range of secondary efficacy endpoints [3][20] - CM-101 demonstrated statistically significant improvements in liver stiffness, total bilirubin, liver function tests, and pruritis, marking it as the first investigational drug to show such effects in PSC [3][5][8][13][14] - Improvements in liver stiffness were observed as early as 15 weeks, with a notable reduction in total bilirubin levels indicating its anti-cholestatic activity [3][13] Safety Profile - CM-101 exhibited a favorable safety profile, with adverse events primarily being mild to moderate, including fatigue, headache, and pruritis, distributed similarly between treatment and placebo groups [7][8] Future Plans - The company is preparing for an End-of-Phase 2 meeting with the FDA to discuss the trial results and the design of a proposed Phase 3 trial for accelerated approval, with plans to initiate the trial in 2025 [17] - An ongoing Open Label Extension (OLE) portion of the SPRING trial allows patients to receive CM-101 for an additional 33 weeks, with results expected in the first quarter of 2025 [18] Market Context - PSC is a rare, progressive liver disease with no approved therapies, affecting an estimated 30,000 patients in the U.S. and 80,000 worldwide, highlighting the significant unmet medical need for effective treatments [21]