Chemomab Therapeutics(US:CMMB) Globenewswire·2025-11-06 13:00Core Insights - Chemomab Therapeutics announced new clinical data from the Phase 2 SPRING trial of nebokitug for primary sclerosing cholangitis (PSC), showing favorable safety and consistent improvements in key biomarkers over 48 weeks of treatment [1][2] Group 1: Clinical Trial Results - The open-label extension (OLE) of the SPRING trial demonstrated that nebokitug was well-tolerated and maintained its anti-inflammatory and anti-fibrotic effects for up to 48 weeks, with significant improvements in biomarkers such as ELF score and liver stiffness [2][3] - Out of 54 eligible patients who completed the initial 15-week double-blind portion, 50 chose to continue in the OLE, receiving up to 33 additional weeks of treatment [3] - The results support the evaluation of nebokitug at a dosage of 20 mg/kg in a Phase 3 trial for PSC patients [3] Group 2: Mechanism of Action - Nebokitug targets macrophage-mediated mechanisms in PSC, showing dose-dependent reductions in serum macrophage-related proteins, particularly in patients with moderate to advanced disease [4][5] - The treatment led to increased expression of macrophage stimulating protein 1 (MST1), which is functionally impaired in PSC patients due to a genetic variant [6] - Changes in MST1 levels were associated with improvements in liver stiffness measurements, indicating its potential as a biomarker for nebokitug's activity [6] Group 3: Future Directions - Chemomab is preparing for a Phase 3 trial based on positive data from the Phase 2 SPRING trial, with a focus on a clinical event primary endpoint to streamline regulatory approval [10] - Nebokitug has received FDA and EMA Orphan Drug designations and FDA Fast Track designation for PSC treatment, highlighting its potential in addressing unmet medical needs [10]