Chemomab Therapeutics Ltd. 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 is the first investigational drug being developed for PSC to exhibit broad, clinically relevant effects on all three components of the disease, providing further evidence of its multifactorial mechanism of action and disease-modifying potential.

The double-blind placebo-controlled SPRING study assessed two doses of CM-101 (10 mg/kg and 20 mg/kg) administered to PSC patients every three weeks over 15 weeks. A total of 76 patients from the U.S., Europe and Israel were treated in the trial. The study analysis included assessments of all patients who completed all doses and the Week 15 visit, as well as a prespecified subgroup analysis of moderate/advanced patients with a higher risk of more rapidly progressing disease.

This population was defined as patients with a vibration-controlled transient elastography (VCTE) measure at baseline of greater than 8.7 kPa. Approximately half of the SPRING study patients were classified as having moderate/advanced disease, which is similar to the overall PSC patient population.