Chemomab receives approval to commence Ph II clinical trial for CM-101

Israel based Chemomab Ltd., a clinical-stage biotech company focusing on discovery and development of innovative therapeutics for fibrosis-related diseases, announced that it has received all necessary regulatory approvals in the UK and Israel to commence a Phase II clinical trial for CM-101 as a treatment for Primary Sclerosing Cholangitis (PSC).

The clinical trial which is a multicentre, double-blind, placebo-controlled study is designed to evaluate the safety and efficacy profile of CM-101 in adult subjects with PSC. The primary endpoints of the trial include a change in Alkaline phosphatase (ALP) and Enhanced Liver Fibrosis (ELF) over 15 weeks of treatment coverage. Secondary endpoints include safety and tolerability of CM-101 as well as the elucidation of CM-101 pharmacokinetic profile and additional efficacy evaluation, as assessed by various liver health, fibrotic, and fibrogenesis markers.

The clinical trial will be conducted in the UK and Israel and will enroll up to 45 patients randomized in a 2:1 ratio between drug and placebo.