Chemomab Therapeutics has enrolled the first subject in its Phase IIa study of humanised monoclonal antibody CM-101 in Non-Alcoholic Steatohepatitis (NASH) patients.
A first-in-class antibody CM-101 can potentially attach to and hinder CCL24 activity, a vital chemokine activity that causes inflammation and fibrosis development.
The multi-centre, randomised, double-blind, placebo-controlled, multiple-dose study will analyse the mechanism of action, safety, pharmacokinetics and pharmacodynamic effects, and the anti-fibrotic effects of subcutaneous CM-101 in NASH patients with fibrosis stage F2-F3.
It will enrol 40 subjects and is expected to conclude enrolment by the end of this year with results anticipated in the first half of next year.
In the study, subjects will be given eight subcutaneous doses of CM-101 every two weeks for 14 weeks. They will be evaluated for serum fibrotic and fibrolysis markers, serum inflammatory markers, liver fat content, and liver stiffness.
Chemomab CEO Dr Adi Mor said: “We are excited to initiate this Phase IIa study of CM-101 in NASH, one of our three Phase II studies for CM-101.
“Data from this study will help validate our subcutaneous delivery of CM-101 and, if successful, the subcutaneous formulation has the potential to be used in our registrational trials for primary sclerosing cholangitis (PSC) and systemic sclerosis (SSc).”
In February this year, Chemomab had enrolled the first subject in a Phase IIa SPRING trial of CM-101 for treating PSC patients.
This multi-centre, double-blind, placebo-controlled study was designed to assess the safety and efficacy profile of CM-101 in adult participants with PSC for 15 weeks.
The company plans to commence an additional Phase II trial of the antibody for SSc treatment in the second half of this year.