TEL AVIV, Israel, July 21, 2020 /PRNewswire/ -- Chemomab Ltd., a clinical-stage biotech company focusing on discovery and development of innovative therapeutics for fibrosis-related diseases, today announces that it has received all necessary regulatory approvals in the UK and Israel, to commence a Phase IIa clinical trial for CM-101 as treatment for Primary Sclerosing Cholangitis (PSC).
The clinical trial is a multicenter, double-blind, placebo-controlled study designed to evaluate the safety and efficacy profile of CM-101 in adult subjects with PSC. The primary endpoints of the clinical trial include change in Alkaline phosphatase (ALP) and Enhanced Liver Fibrosis (ELF) over 15 weeks of treatment coverage. Secondary endpoints will include safety and tolerability of CM-101 as well as 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.
"Our CM-101 program in PSC is generating a lot of enthusiasm from our clinical research partners, and we are very pleased that renowned and respected investigators will participate in our study," said Dr. Adi Mor, CEO and CSO of Chemomab. "PSC patients currently have significant unmet need for effective treatment options and we have sincere hopes that CM-101 will be a significant and efficient addition in the battle with this disease. We look forward to start this study that will provide us with safety and first evidence of efficacy in PSC patients and particularly demonstrate the anti-fibrotic activity of CM-101."
"We are excited to start the efficacy testing phase of CM-101 in PSC," said Dr. Arnon Aharon, CMO of Chemomab. "CM-101 has a unique mechanism of action and has shown very promising pre-clinical results in liver fibrosis in general and in PSC in particular. We are assessing the COVID-19 pandemic situation in the UK and Israel and plan to start the clinical trial in the near future."
Chemomab is a clinical-stage biotech company focusing on the discovery and development of innovative therapeutics for fibrosis-related diseases with great unmet need. Based on the unique and pivotal role of the soluble protein CCL24 in promoting fibrosis and inflammation, Chemomab generated a novel CCL24 blocking monoclonal antibody that is currently in development for the treatment of patients with primary sclerosing cholangitis (PSC), systemic sclerosis and nonalcoholic steatohepatitis (NASH). During Q3 2020 Chemomab will initiate the first phase 2a clinical trial evaluating the safety and efficacy of CM-101 in subjects with Primary Sclerosing cholangitis (SPRING Study).
ChemomAb is a privately held company and is supported by strong lead investors that include OrbiMed and Thiel Capital.
Chemomab's CM-101 Platform, is a first-in-class humanized monoclonal antibody designed to bind to and block CCL24 activity. CM-101 interferes with the main pathologies that promote fibrosis and inflammation. It is highly effective in ameliorating fibrosis, as shown across multiple in vivo, in vitro and ex vivo studies, including experimental models of liver, skin and lung fibrosis. CM-101 was shown to be safe and well-tolerated in phase I clinical trials in healthy volunteers and NAFLD patients and is currently under clinical development for Primary Sclerosing Cholangitis (PSC), Systemic Sclerosis (SSc) and Non-Alcoholic Steatohepatitis (NASH).
Mr. Sharon Elkobi
VP of Business Development
SOURCE ChemomAb Ltd.