On the recent advancement in the treatment of primary sclerosing cholangitis (PSC).
Here’s a summary of the key points:
Fast Track Designation: The FDA has granted fast track status to Chemomab Therapeutics’ anti-CCL24 monoclonal antibody, CM-101, for the treatment of adults with primary sclerosing cholangitis.
About CM-101: CM-101 is a first-in-class CCL24-neutralizing monoclonal antibody. It has been linked to crucial pathways in the underlying pathophysiology of primary sclerosing cholangitis. The antibody’s dual anti-inflammatory and anti-fibrotic activity aims to disrupt the cycle driving these pathways. CM-101 has shown promise as a disease-modifying therapy for PSC in preclinical and early clinical studies.
Phase 2 SPRING Trial: The phase 2 SPRING trial is a double-blind, placebo-controlled study designed to assess the safety and tolerability of CM-101 in patients with PSC. It also aims to measure a range of relevant biomarkers and physiological parameters within the disease. With patient enrollment nearing completion, top-line safety and tolerability data are expected in the second half of 2024.
Therapeutic Potential: The therapeutic potential of CM-101 is supported by promising biomarker and elastography results from a phase 2a liver fibrosis study in nonalcoholic steatohepatitis (NASH) patients. There are common fibrosis pathways in NASH and PSC, and CM-101’s relevance to PSC is backed by extensive preclinical and patient sample studies.
FDA’s Fast Track Status: The FDA’s fast track status is intended to facilitate the development of new products for serious or life-threatening conditions that show potential to address unmet medical needs. This status will allow Chemomab to work closely with the FDA to expedite the review of aspects of CM-101, improving the efficiency of product development.
This development represents a significant step forward in the treatment of primary sclerosing cholangitis, a condition that currently lacks approved treatments and affects people in their prime years.