Chemomab Therapeutics announced positive 48-week data from the open-label extension (OLE) of its Phase 2 SPRING trial for nebokitug in primary sclerosing cholangitis (PSC). The results showed continued improvement in key liver injury, inflammation, and fibrosis biomarkers and a lower rate of clinical events compared to historical controls. Over 90% of eligible SPRING trial participants opted to continue into the OLE, highlighting patient interest in a potential new treatment.
This data strengthens the case for nebokitug as a potential disease-modifying therapy for PSC, a severe liver disease with no currently approved treatments. The sustained positive effects observed over 48 weeks, particularly in patients with moderate to advanced disease, provide valuable insights for the design and execution of the upcoming Phase 3 trial. Confirmation of the drug’s safety and tolerability over a longer treatment period further de-risks the Phase 3 program.
The OLE results corroborated earlier findings from the 15-week double-blind portion of the SPRING trial. Key fibrotic biomarkers, including ELF score components and PRO-C3, showed continued improvement. Liver stiffness progression was significantly reduced compared to historical controls. Importantly, the 20 mg/kg dose, intended for the Phase 3 trial, demonstrated robust efficacy. The lower number of clinical events observed in the nebokitug group compared to historical controls provides further support for the chosen primary endpoint in the Phase 3 trial.
These positive results pave the way for a streamlined Phase 3 trial focusing on clinical events, potentially expediting the path toward regulatory approval. Nebokitug holds promise as a first-in-class treatment for PSC, offering hope to patients currently facing limited therapeutic options and the risk of serious complications like liver transplantation and death. The upcoming Phase 3 trial will be critical in confirming these findings and establishing nebokitug’s clinical benefit.
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.
