Chemomab Therapeutics Announces FDA Clearance of INDA for Phase 2 Trial of CM-101 By Investing.com

Chemomab Therapeutics, Ltd. (Nasdaq: CMMB) 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.

Matt Frankel, MD, Chief Medical Officer of Chemomab, said, “Achieving FDA clearance to initiate our Phase 2 systemic sclerosis trial is an important milestone for Chemomab. We are encouraged by the results of recent clinical studies of CM-101 in COVID patients with SSc-like acute lung injury and in NASH patients, which showed consistent trends in reducing multiple biomarkers associated with fibro-inflammatory disease. We believe that CM-101 has the potential to become the first disease-modifying treatment for this debilitating condition that is thought to be the most lethal of the systemic rheumatic disorders. We look forward to initiating patient enrollment in the first half of this year.“

Francesco Del Galdo, MD, PhD, Professor of Experimental Medicine at the University of Leeds in the U.K. and Head of the Scleroderma Programme at the Leeds Institute of Rheumatic and Musculoskeletal Medicine, is the Principal Investigator of the Chemomab systemic sclerosis trial.

Professor Del Galdo noted, “Preclinical studies conducted by me and my colleagues show that CCL24, the disease target of CM-101, appears to be a key driver of the immune-driven fibrosis affecting tissues including the lung, skin and blood vessels that are key aspects of SSc pathology. Our patients and we, as their physicians, urgently need an effective therapy able to treat the multiple manifestations of scleroderma. I welcome the opportunity to help launch and coordinate this innovative clinical trial for patients with SSc in the U.S., Europe and Israel, scheduled to open later this year.”