Chemomab Reports Positive Feedback From Two Recent FDA Meetings Supporting Phase 3 Advancement of Nebokitug in Primary Sclerosing Cholangitis

Core Insights - Chemomab Therapeutics has achieved significant milestones with the FDA regarding the development of nebokitug for primary sclerosing cholangitis (PSC) [1][4] - The FDA has agreed on the Chemistry, Manufacturing, and Controls (CMC) strategy and the non-clinical toxicology testing pathway for nebokitug, allowing for parallel testing during the Phase 3 clinical trial [2][3] Company Overview - Chemomab Therapeutics is a clinical-stage biotechnology company focused on developing therapeutics for fibro-inflammatory diseases, particularly targeting the soluble protein CCL24 [8] - Nebokitug (CM-101) is a first-in-class dual activity monoclonal antibody that neutralizes CCL24, showing potential in treating severe fibro-inflammatory diseases [5][8] Clinical Development - The company is preparing for a Phase 3 clinical trial of nebokitug, building on positive results from the Phase 2 SPRING trial, which met its primary safety endpoint and showed improvements in secondary endpoints [5][8] - Nebokitug has received FDA and EMA Orphan Drug designations and FDA Fast Track status for PSC treatment, indicating its potential significance in addressing unmet medical needs [5][8]