Chemomab highlights clincial activity of CM-101 at The Liver Meeting 2024

Chemomab Therapeutics (CMMB) announced that data from its Phase 2 SPRING trial in patients with primary sclerosing cholangitis was presented at the American Association for the Study of Liver DiseaseThe Liver Meeting 2024. In the oral, late-breaking presentation, “CM-101 improved fibrosis biomarkers in patients with primary sclerosing cholangitis: The Phase 2 SPRING Study,” Professor Christopher Bowlus, MD, FAASLD, a SPRING trial investigator and the Lena Valente Professor and Chief of the Division of Gastroenterology and Hepatology at the University of California Davis School of Medicine, discussed data from the double-blinded, placebo-controlled portion of the Phase 2 SPRING trial assessing CM-101 in patients with PSC. The Phase 2 SPRING study tested two doses of CM-101 administered to PSC patients every three weeks over 15 weeks. A total of 76 patients were treated in the trial. The study analysis included assessments of all patients who completed all doses and the week 15 visit, as well as a prespecified subgroup analysis of moderate/advanced patients with a higher risk of more rapidly progressing disease. CM-101 met the SPRING trial primary endpoint, demonstrating a favorable safety profile over the 15-week treatment period. Adverse events were generally mild/moderate and distributed similarly between the placebo and CM-101-treated dosing arms. Overall, dose-dependent responses were observed for multiple disease-related biomarker secondary endpoints. A consistent pattern of greater improvement on the secondary endpoints was observed in the study arm receiving the higher 20 mg/kg dose of CM-101 and in the subgroup of PSC patients with moderate/advanced disease. Secondary endpoint data included the following: Liver stiffness: Liver stiffness measured by FibroScan improved in all CM-101 treated patients compared to placebo and significantly improved in CM-101-treated patients with moderate/advanced disease. ELF scores: This composite score consistently improved over the treatment period in patients with moderate/advanced fibrosis treated with 20 mg/kg of CM-101 compared to patients receiving placebo. Patients receiving the higher dose of CM-101 with moderate/advanced disease also showed statistically significant reductions at week 15 in the fibrosis-related ELF components procollagen III N-terminal peptide and tissue inhibitor of metalloproteinase 1. PRO-C3: This serum biomarker of type III collagen synthesis was reduced in all CM-101-treated patients and showed greater reductions in patients with moderate- advanced disease. Liver biochemistries: A consistent pattern of decline was seen in CM-101 20 mg/kg treated-patients compared to placebo and a greater decline was seen in patients with moderate/advanced disease. Bilirubin: The dose-dependent improvement in total bilirubin levels seen in CM-101-treated patients provides evidence for the anti-cholestatic activity of CM-101. Pruritis: CM-101-treated patients experienced decreased pruritus scores across all timepoints compared to placebo. In conclusion, Dr. Bowlus noted that CM-101 was well tolerated and had a safety profile comparable to placebo, and it demonstrated dose-dependent anti-inflammatory, anti-fibrotic and anti-cholestatic effects in patients with PSC. PSC patients with moderate to advanced disease treated with CM-101 showed broad and consistent improvement in biomarkers associated with clinical outcomes. He concluded that these findings support further clinical development of CM-101 in patients with PSC. An open label extension portion of the Phase 2 SPRING trial, in which all eligible patients can receive CM-101 for an additional 33 weeks, is continuing, with results expected to be reported in the first quarter of 2025.