Core Insights - Nebokitug shows potential to be the first approved drug with disease-modifying activity for primary sclerosing cholangitis (PSC), a severe condition with no effective treatments currently available [1][2] - The Open Label Extension (OLE) of the Phase 2 SPRING trial demonstrated that treatment with nebokitug for 48 weeks led to significant improvements in key biomarkers of liver injury, inflammation, and fibrosis [1][2] - The treatment was well-tolerated, reinforcing positive results from the initial 15-week double-blind Phase 2 trial [1][2] Clinical Trial Results - In the OLE study, over 90% of eligible SPRING trial patients chose to continue treatment, with those previously on placebo receiving nebokitug for an additional 33 weeks, totaling up to 48 weeks of treatment [1][8] - Patients treated with nebokitug showed a significantly lower number of clinical events (4.8%) compared to historical controls (25.8%) [2][8] - Improvements were observed in liver stiffness scores, with nebokitug-treated patients showing substantial reductions compared to historical controls [2][4] Biomarker Improvements - Key liver biomarkers, including ELF score and PRO-C3, showed continued improvement over the treatment period [2][7] - Cholestasis-related markers stabilized, and total serum bile acids were reduced during the 48 weeks of treatment [2][8] - The results were particularly strong in patients with moderate/advanced disease, which is the focus for the upcoming Phase 3 trial [2][7] Future Development - The positive results from the OLE study are expected to derisk the Phase 3 clinical trial design, which will focus on the number of clinical events as the primary endpoint [2][7] - Nebokitug has received FDA and EMA Orphan Drug designations and FDA Fast Track status for PSC treatment, indicating a streamlined pathway for regulatory approval [9][13] - The company is preparing for the potential initiation of a Phase 3 trial based on the promising data from the Phase 2 SPRING trial [12][13]
Chemomab Reports Positive Results in Nebokitug Phase 2 PSC Open Label Extension Trial Showing Continued Broad and Substantial Improvements in Key Liver Biomarkers