Chemomab OKd for Phase 2 Trial of CM-101 in Systemic Sclerosis

  Chemomab Therapeutics, Ltd. (Nasdaq: CMMB) (Chemomab), a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced U.S. Food and Drug Administration (FDA) clearance of the company's Investigational New Drug (IND) Application to evaluate CM-101 in a Phase 2 trial in adults with systemic sclerosis (SSc).

CM-101 is a first-in-class monoclonal antibody designed to interfere with key biological pathways associated with SSc and other serious fibro-inflammatory diseases. In preclinical studies, CM-101 reduced inflammatory and fibrotic injury to the lung, skin and vasculature—organ systems often affected in SSc patients. In early clinical trials, CM-101 was well-tolerated, reducing fibrogenesis-related biomarkers and demonstrating anti-inflammatory effects in patients with severe lung inflammation, non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). CM-101 has been granted Orphan Drug designation by the FDA for SSc and for primary sclerosing cholangitis (PSC), a rare liver disease. The CM-101 Phase 2 SPRING trial in PSC patients is currently ongoing.

https://finance.yahoo.com/news/chemomab-announces-fda-clearance-investigational-120000601.html