CM-101 Phase 2 PSC Trial Completes Enrollment; Topline Results Expected Mid-2024

Chemomab Therapeutics, a company dedicated to developing treatments for fibro-inflammatory diseases, has successfully completed patient recruitment for its Phase 2 clinical trial of CM-101. The trial is aimed at evaluating the drug's efficacy in treating primary sclerosing cholangitis (PSC), a severe liver condition that currently lacks FDA-approved treatments. The company has managed to expedite the expected release of the trial's primary data to midyear 2024, moving it up from the initial projection of the latter half of the year.

Adi Mor, the co-founder and CEO of Chemomab, expressed enthusiasm about the accelerated timeline for the PSC clinical data, attributing it to the swift completion of patient enrollment. He emphasized CM-101's potential to alter the course of PSC, a disease that often leads to liver transplants or can be fatal. The drug has been granted Orphan Drug status in the U.S. and EU, and has also received Fast Track designation from the FDA, indicating its potential to address unmet medical needs.

CM-101 is a pioneering monoclonal antibody designed to neutralize CCL24, a protein linked to the fundamental mechanisms of PSC. It has shown promise in both reducing inflammation and fibrosis, key features of PSC and other related disorders. The Phase 2 SPRING trial, which has enrolled 68 patients across the U.S., EU, and Israel, is a rigorous, double-blind, placebo-controlled study. It assesses the safety and tolerability of CM-101 administered to patients with PSC, with dosages of either 10 mg/kg or 20 mg/kg given via intravenous infusion every three weeks for 15 weeks. The study also includes an open label extension phase, offering continued treatment to all participants for an additional 33 weeks.

The trial's primary focus is on safety, but it also monitors a broad spectrum of secondary outcomes, encompassing serum biomarkers and physiological measures. These include established liver health indicators such as alkaline phosphatase, ELF, PRO-C3, and liver stiffness assessments using FibroScan technology.

PSC is a rare and progressive affliction that leads to inflammation and scarring of the bile ducts, potentially resulting in liver cirrhosis and failure. It also heightens the risk of certain cancers, which are responsible for approximately half of the disease's mortality rate. The condition affects roughly 30,000 individuals in the U.S. and an estimated 80,000 globally. It is more prevalent among men and is typically diagnosed in the 40s. While the exact cause of PSC remains unknown, a significant number of patients also suffer from inflammatory bowel disease. Liver transplantation is a common course of action in advanced stages, although the disease can recur in transplant recipients. The demand for new therapeutic options to manage symptoms and slow disease progression is significant.

Chemomab Therapeutics is at the forefront of addressing this demand with CM-101, which has shown promising results in previous trials involving patients with nonalcoholic fatty liver disease and nonalcoholic steatohepatitis. The company's commitment to advancing treatments for fibro-inflammatory diseases is evident through its clinical trials and the development of CM-101, which holds the potential to become a groundbreaking therapy for PSC and other related conditions.