FDA grants fast track status to monoclonal antibody for primary sclerosing cholangitis
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The FDA has granted fast track designation to Chemomab Therapeutics’ anti-CCL24 monoclonal antibody, CM-101, for the treatment of adults with primary sclerosing cholangitis, according to a manufacturer release.
In preclinical and clinical studies, CM-101, a first-in-class CCL24-neutralizing monoclonal antibody, has been linked to crucial pathways in underlying primary sclerosing cholangitis pathophysiology. Chemomab noted that the antibody’s dual anti-inflammatory/anti-fibrotic activity is intended to “break the vicious cycle driving these pathways,” and has shown promise as a disease-modifying therapy for PSC-related processes in preclinical/early clinical studies.
“This FDA fast track designation is an important validation of CM-101’s potential to have a major impact on this devastating disease that attacks people in their prime years and lacks any approved treatments,” Adi Mor, PhD, co-founder, CEO and chief scientific officer of Chemomab, said in a press release. “We designed the CM-101 phase 2 SPRING trial to be supportive of a registrational trial in patients with PSC, and we welcome the enhanced opportunities for working closely with the FDA and for acceleration of the development and review process provided by fast track status.”
A double-blind, placebo-controlled study intended to assess safety and tolerability of Chemomab’s monoclonal antibody in patients with PSC, the phase 2 SPRING trial is also meant to measure a wide range of relevant biomarkers and physiological parameters within the disease. With patient enrollment nearing completion, the company expects to release top-line safety and tolerability data in the second half of 2024.
“Promising biomarker and elastography results from our phase 2a liver fibrosis study in nonalcoholic steatohepatitis (NASH) patients reported earlier this year reinforced our optimism about the therapeutic potential of CM-101,” Matt Frankel, MD, chief medical officer at Chemomab, said in the release. “There are common fibrosis pathways in NASH and PSC, and CM-101’s relevance to PSC is supported by extensive preclinical and patient sample studies.”
He added: “We also are encouraged by robust patient enrollment in the SPRING trial, which speaks to the high unmet need experienced by these patients. We look forward to continuing our work with PSC patients, their clinicians and the FDA to expedite advancement of CM-101 as a potential treatment for this terrible disease.”
The FDA provides fast track status to facilitate the development of new products for serious or life-threatening conditions that demonstrate the potential to address unmet medical needs, with the goal of getting important new products to patients earlier. Fast track status will also allow Chemomab to work closely with the FDA to expedite the review of aspects of CM-101 to improve the efficiency of product development.
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