Chemomab Therapeutics Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted CM-101 Fast Track designation for the treatment in adult patients of primary sclerosing cholangitis (PSC), a fibrotic liver disease that can result in liver transplant, cancer and early death. Fast Track is a process developed by the FDA to facilitate and expedite the development of new treatments that demonstrate a potential to address unmet medical needs in serious or life-threatening conditions. Programs with Fast Track designation can benefit from early and more frequent interactions with the FDA during the clinical development process.

Therapeutic candidates with Fast Track designation may also be eligible for priority review and accelerated approval if supported by clinical data. There are no FDA-approved treatments for PSC. CM-101 is a first-in-class monoclonal antibody that neutralizes the soluble protein CCL24, which in preclinical and clinical studies has been associated with key pathways underlying PSC pathophysiology.

CM-101's dual anti-inflammatory and anti-fibrotic activity, which is designed to break the vicious cycle driving these pathways, has demonstrated the potential for disease modifying activity in preclinical and early clinical studies of PSC-related processes. Chemomab's Phase 2 SPRING trial (NCT04595825) is a double-blind, placebo-controlled study assessing the safety and tolerability of CM-101 in PSC patients. The trial is also measuring a wide range of relevant biomarkers and physiological parameters.

Patient enrollment in the trial is advancing towards completion and Chemomab anticipates reporting a top-line readout in the second half of 2024.