Core Insights - Chemomab Therapeutics has announced positive results from its Phase 2 SPRING trial for nebokitug, a treatment for primary sclerosing cholangitis (PSC), which supports advancing to a Phase 3 registration trial [1][3] Group 1: Trial Results - The Phase 2 SPRING trial demonstrated that nebokitug was generally safe and well tolerated for up to 48 weeks, with significant improvements in biomarkers for inflammation and fibrosis, particularly at the 20 mg/kg dose [2][7] - In patients with moderate/advanced fibrosis, nebokitug showed a dose-dependent biological activity, with about half of the study population falling into this category [7][10] - The trial included 76 patients across 33 sites in the US, UK, Germany, Spain, and Israel, with over 90% of eligible patients opting for an open-label extension study [6] Group 2: Mechanism of Action - Nebokitug is a humanized IgG1 anti-CCL24 monoclonal antibody that targets CCL24, which is associated with inflammatory and fibrotic processes in PSC [5][12] - Elevated CCL24 levels have been linked to disease severity in PSC, and inhibiting CCL24 with nebokitug has shown therapeutic benefits in experimental models [5][12] Group 3: Future Prospects - Based on the positive data from the SPRING trial, Chemomab is preparing to initiate a Phase 3 trial, which will focus on a clinical event primary endpoint to streamline the regulatory approval process [12] - Nebokitug has received Orphan Drug and Fast Track designations from the FDA, indicating its potential significance in treating PSC [12]
Chemomab Therapeutics Announces Nebokitug Phase 2 SPRING Trial Results in Primary Sclerosing Cholangitis Published in the American Journal of Gastroenterology