Chemomab Reports Independent Drug Monitoring Committee Safety Review of CM-101 Phase 2 Trial in Primary Sclerosing Cholangitis
Dec 21, 2022
TEL AVIV, Israel, Dec. 21, 2022 /PRNewswire/ — Chemomab Therapeutics, Ltd. (Nasdaq: CMMB) (Chemomab), a clinical-stage biotech company focused on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet need, today announced that an independent Data Monitoring Committee (DMC) has completed a safety review of the company’s ongoing Phase 2 trial of lead product CM-101 in primary sclerosing cholangitis (PSC) patients. The DMC had no safety concerns with proceeding with adding a planned 20 milligram per kilogram (mg/kg) dosing cohort to the PSC trial, as defined in a recent protocol amendment. The PSC trial currently has a single 10mg/kg dose, administered every three weeks by intravenous (IV) infusion.
The DMC review was based on both blinded safety data from the PSC trial and from Chemomab’s Phase 2a liver fibrosis biomarker trial in patients with non-alcoholic steatohepatitis (NASH). Chemomab plans to report top-line results from this latter trial in the coming weeks.
“Our first-in-class CCL24-neutralizing antibody, CM-101, had demonstrated a clean safety profile in Phase 1 trials, and we are pleased the DMC review of current Phase 2 patient data has confirmed these findings,” said Matthew Frankel, MD, Chief Medical Officer of Chemomab. “We view PSC as a promising clinical indication for CM-101 based on the extensive preclinical and translational data generated by our researchers, which highlights both the potential role of the soluble target CCL-24 in PSC-related disease pathophysiology and evidence of CM-101’s potential to attenuate these fibro-inflammatory processes.”
The CM-101 Phase 2 SPRING trial is a randomized, placebo-controlled, multiple dose study enrolling PSC patients with large duct disease. In the trial’s double blind treatment period, all enrolled patients receive five IV administrations of either CM-101 or placebo every three weeks over a 15-week treatment period. The trial also includes an open label extension, with administration of up to 11 additional doses of CM-101 given every three weeks. The addition of the open label extension brings the maximal duration of treatment to 48 weeks. The primary outcome of the trial is safety and tolerability, with secondary outcomes including a wide range of relevant biomarkers and physiological assessments. Top-line data from the Phase 2 PSC trial is expected in the second half of 2024.