Chemomab Therapeutics announced positive Phase 2 SPRING trial data for nebokitug (CM-101) in patients with primary sclerosing cholangitis (PSC) at BSG Live’25. The trial showed nebokitug was well-tolerated and demonstrated dose-dependent anti-inflammatory, anti-fibrotic, and anti-cholestatic effects, particularly in patients with moderate to advanced disease. The open-label extension of the trial confirmed the safety and tolerability of nebokitug for up to 48 weeks and showed sustained improvement in fibrosis markers.
This news is crucial because PSC is a severe, progressive liver disease with no currently approved therapies. The positive results from the SPRING trial offer hope for patients facing this devastating diagnosis, indicating a potential disease-modifying treatment may be on the horizon. The observed improvement in multiple biomarkers, especially in those with more advanced disease, suggests nebokitug could significantly alter the PSC disease course and improve patient outcomes.
The Phase 2 trial evaluated the safety and efficacy of nebokitug over 15 weeks in a double-blind, placebo-controlled setting, followed by an open-label extension of up to 33 weeks. Key findings include the drug’s favorable safety profile and consistent, dose-dependent improvements in biomarkers linked to better clinical outcomes in PSC. The open-label extension reinforced the long-term safety and tolerability of nebokitug while demonstrating sustained improvement in relevant disease markers.
The positive Phase 2 data supports Chemomab’s plans to advance nebokitug to a Phase 3 registration trial. This next step aims to confirm the clinical benefits observed in Phase 2 and could pave the way for nebokitug to become the first approved treatment for PSC, addressing a significant unmet medical need. The progress of nebokitug holds significant promise for transforming the treatment landscape for PSC patients.
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.
