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Chemomab Therapeutics Secures FDA Fast Track Designation for CM-101 in the Treatment of Primary Sclerosing Cholangitis

Thursday, November 16, 2023

Chemomab Therapeutics Ltd. (Nasdaq: CMMB) has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for its experimental therapy, CM-101, developed to treat primary sclerosing cholangitis (PSC). This severe fibrotic liver disease currently lacks approved treatments, and Fast Track designation aims to expedite the development of potential therapies for serious conditions with unmet medical needs.

CM-101, a novel monoclonal antibody, targets the soluble protein CCL24 associated with crucial pathways in PSC pathophysiology. In preclinical and early clinical studies, CM-101 has shown dual anti-inflammatory and anti-fibrotic activity, indicating potential disease-modifying effects. The Phase 2 SPRING trial (NCT04595825), a double-blind, placebo-controlled study evaluating CM-101's safety and tolerability in PSC patients, is expected to report top-line results in the second half of 2024.

FDA's Fast Track designation as a significant validation of CM-101's potential to address the unmet needs in PSC treatment. Dr. Matt Frankel, Chief Medical Officer, expressed optimism based on positive results from a Phase 2a liver fibrosis study in nonalcoholic steatohepatitis (NASH) patients, reinforcing the therapeutic potential of CM-101.

PSC is a rare, progressive liver disease leading to inflammation and fibrosis of bile ducts, potentially resulting in cirrhosis, liver failure, and an increased risk of cancer. Despite affecting an estimated 30,000 patients in the U.S. and about 80,000 worldwide, there are currently no FDA or EMA-approved therapies for PSC, highlighting the high unmet need for effective treatment options. CM-101, with its Orphan Drug designation, represents a promising candidate for addressing the symptoms and modifying the progression of this devastating illness.



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