Chemomab Therapeutics Ltd CMMB shares are trading higher on Tuesday after the company announced FDA clearance of its Investigational New Drug Application to evaluate CM-101 in a Phase 2 trial in adults with systemic sclerosis.
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. It has been granted Orphan Drug designation by the FDA (U.S. Food and Drug Administration) 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 believe that CM-101 has the potential to become the first disease-modifying treatment for the 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."
Chemomab is a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for fibro-inflammatory diseases with high unmet need.
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CMMB Price Action: Chemomab has a 52-week high of $5.56 and a 52-week low of $1.75.
Chemomab shares are up 20.4% at $2.35 at the time of publication, according to Benzinga Pro.
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