CM-101 Met Primary Endpoint of Safety and Tolerability and Showed Positive Activity Across Multiple Liver Fibrosis Biomarkers and Physiologic Assessments ChemomAb Ltd a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet need, today reported top-line results from its Phase 2a trial assessing CM-101, its first-in-class CCL24-neutralizing monoclonal antibody, in non-alcoholic steatohepatitis (NASH) patients. The trial met its primary endpoint of safety and tolerability, and CM-101 achieved reductions in secondary endpoints that include a range of liver fibrosis biomarkers and physiologic assessments measured at baseline and at week 20. The randomized, placebo-controlled trial enrolled 23 NASH patients with stage F1c, F2 and F3 disease who were randomized to receive either CM-101 or placebo. Patients received eight doses of 5 mg/kg of CM-101 or placebo, administered by subcutaneous (SC) injection once every two weeks, for a treatment period of 16 weeks. This trial was primarily designed to assess the subcutaneous formulation of CM-101 and to evaluate the drug's impact on liver fibrosis biomarkers relevant to both NASH and the rare fibro-inflammatory conditions that represent the focus for the company, such as primary sclerosing cholangitis (PSC) and systemic sclerosis (SSc). Dale Pfost, PhD, Chief Executive Officer of Chemomab, said, "It is noteworthy that this trial confirmed the safety and tolerability of CM-101 and the pharmacokinetics of our subcutaneous formulation, while providing biomarker data further demonstrating the anti-inflammatory and anti-fibrotic activity of CM-101. We are especially pleased with these encouraging findings given the small size of the study, the short duration of treatment and the relatively low dose of CM-101 that was administered." Dr. Pfost continued, "This is the third clinical trial in patients demonstrating the activity of CM-101 as measured by fibro-inflammatory biomarkers and physiological assessments. It confirms similar data we reported in our Phase 1b study in patients with non-alcoholic fatty liver disease (NAFLD) and in our recently reported investigator study of acute lung injury in COVID patients. Collectively, these data encompassing diverse organs and conditions reinforce our optimism about our ongoing Phase 2 trial in primary sclerosing cholangitis and our Phase 2 trial in systemic sclerosis that is scheduled to begin early this year.
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