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]

Core Insights - The SPRING trial data indicates that nebokitug is a promising first-in-class treatment for primary sclerosing cholangitis (PSC), showing substantial improvements in multiple biomarkers associated with disease progression [1][2][3] - Nebokitug has demonstrated a favorable safety profile, being well-tolerated over 48 weeks of treatment, and is advancing towards a Phase 3 registration trial [2][3][4] Company Overview - Chemomab Therapeutics is a clinical stage biotechnology company focused on developing innovative therapeutics for fibro-inflammatory diseases, with nebokitug (CM-101) being a dual activity monoclonal antibody targeting CCL24 [7] - The company has received FDA and EMA Orphan Drug designations and FDA Fast Track designation for nebokitug in the treatment of PSC, indicating its potential significance in addressing unmet medical needs [7] Clinical Trial Details - The Phase 2 SPRING trial was a double-blind, placebo-controlled study that showed nebokitug's dose-dependent anti-inflammatory, anti-fibrotic, and anti-cholestatic effects in patients with PSC [2][3] - In a prespecified subgroup of patients with moderate to advanced disease, those treated with nebokitug exhibited broad and consistent improvements in biomarkers linked to better clinical outcomes [2] Future Prospects - The company is preparing to initiate a Phase 3 trial for nebokitug, which is designed to provide a clear pathway to potential full regulatory approval [4][7] - The positive results from the SPRING trial support the advancement of nebokitug as a potential first approved therapy for PSC, a condition currently lacking effective treatments [2][4]