Chemomab Therapeutics Ltd. announced early completion of patient enrollment in its Phase 2 clinical trial assessing CM-101 as a treatment for primary sclerosing cholangitis (PSC). The company also announced that it expects to report topline data from the PSC clinical trial by midyear 2024, rather than in the second half of 2024 as previously projected. 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 has demonstrated disease modifying potential in PSC and other fibro-inflammatory disorders. CM-101 has Orphan Drug designation for PSC in the U.S. and the European Union (EU) and was recently awarded Fast Track designation by the U.S. Food & Drug Administration (FDA). Chemomab's Phase 2 SPRING trial (NCT04595825 [2]) is a double-blind, placebo-controlled, multiple dose study assessing the safety and tolerability of CM-101 administered to PSC patients with established large duct disease.

The trial has completed enrollment of the planned 68 patients in the U.S., EU and Israel. Enrolled patients receive either 10 mg/kg or 20 mg/kg of CM-101 or placebo via an intravenous infusion every three weeks over 15 weeks. The SPRING trial includes an open label extension available to all study participants, who receive infusions of either 10 mg/kg or 20 mg/kg of CM-101 every three weeks for an additional 33 weeks.

In addition to safety, the trial is measuring a wide range of secondary outcomes including serum biomarkers and physiological parameters. These include well-validated liver biomarkers such as alkaline phosphatase (ALP), ELF and PRO-C3, as well as FibroScan assessments of liver stiffness.