FDA Gives Green Signal To Chemomab Therapeutics' Rare Disease Study

  • The FDA has signed off Chemomab Therapeutics Ltd's CMMB 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 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). 
  • The FDA has granted CM-101 Orphan Drug designation 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.
  • Price Action: CMMB shares are up 17.95% at $2.31 on the last check Tuesday.
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