Israel's Chemomab Therapeutics, Ltd., a clinical-stage biotech company focused on the discovery and development of innovative therapeutics for fibrosis-related diseases with high unmet need, announced on Monday the enrollment of the first patient in its Phase 2a study of CM-101 in Non-Alcoholic Steatohepatitis (NASH).
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CM-101 is a first-in-class humanized monoclonal antibody designed to bind to and block CCL24 activity, an important chemokine activity that stimulates inflammation and the development of fibrosis.
The Phase 2a study is a multi-center, randomized, double-blind, placebo-controlled, multiple dose study designed to assess the mechanism of action, safety, pharmacokinetics and pharmacodynamic effects, as well as the anti-fibrotic effects of subcutaneous CM-101 in NASH patients with fibrosis stage F2-F3. The trial will enroll 40 patients and is anticipated to complete enrollment by the end of 2021 with data expected in 1H 2022.
"We are excited to initiate this Phase 2a study of CM-101 in NASH, one of our three Phase 2 studies for CM-101," said Dr. Adi Mor, CEO of Chemomab. "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). Our Phase 2 PSC trial is already underway, and we are planning to initiate an additional Phase 2 trial in SSc in 2H 2021."
The study will enroll patients who have a histological confirmation of NASH without cirrhosis on a historical diagnostic liver biopsy. Patients will receive eight subcutaneous injections of CM-101 every two weeks for 14-weeks and will be assessed for serum fibrotic and fibrolysis markers, serum inflammatory markers, liver fat content, and liver stiffness.
