Chemomab Therapeutics announced positive Phase 2 SPRING trial data for nebokitug (CM-101) in primary sclerosing cholangitis (PSC) at Digestive Disease Week 2025. The trial demonstrated that nebokitug is well-tolerated and associated with significant improvements in fibrotic and inflammatory biomarkers, suggesting potential disease modification. This progress supports advancement to a Phase 3 trial.
This news holds considerable promise for PSC patients, who currently lack FDA-approved therapies for this debilitating, progressive liver disease. The positive data from the SPRING trial, particularly the sustained improvements observed in biomarkers associated with disease progression, offers a new potential treatment avenue for a disease with a high unmet need. This advancement represents a significant step towards a potential therapy offering a better quality of life for individuals affected by PSC.
Data from the 15-week double-blind, placebo-controlled period showed nebokitug was well-tolerated with a safety profile comparable to placebo. The drug displayed dose-dependent anti-inflammatory, anti-fibrotic, and anti-cholestatic effects. In patients with moderate to advanced PSC, nebokitug improved several biomarkers linked to better clinical outcomes. Open-label extension data (up to 48 weeks of treatment) reinforced the safety and tolerability profile, showing sustained or continued improvement in markers of fibrosis and a reduction in ELF scores, especially in patients with moderate to advanced disease receiving the 20 mg/kg dose. These patients also saw stabilization of liver stiffness.
The positive Phase 2 results pave the way for a Phase 3 trial. Chemomab is currently evaluating the optimal design for this pivotal study, aiming for a streamlined pathway to potential full regulatory approval. This positive momentum could position nebokitug as a first-in-class treatment for PSC, significantly altering the treatment landscape for this challenging disease.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
