– CM-101 is a first in class CCL24 blocking antibody, that showed a positive safety and tolerability profile in phase I studies and first line evidence of anti-fibrotic activity in a phase Ib study in NAFLD patients

– The SPRING phase IIa study is a multicenter, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of CM-101 in adult subjects with PSC over 15 weeks of treatment

TEL AVIV, Israel I February 2, 2021 IChemomab Ltd., a clinical-stage biotech company focusing on discovery and development of innovative therapeutics for fibrosis-related diseases, today announces enrollment of the first patient in a phase IIa clinical trial of CM-101 for the treatment of patients with primary sclerosing cholangitis (PSC).

The SPRING phase IIa study is a multicenter, double-blind, placebo-controlled study designed to evaluate the safety and efficacy profile of CM-101 in adult subjects with PSC over 15 weeks of treatment. The study is being conducted at multiple leading sites in the United Kingdom and Israel, and will enroll up to 45 patients randomized in a 2:1 ratio between CM-101 and placebo.

CM-101 is a CCL24 blocking monoclonal antibody platform that demonstrates amelioration of fibrosis and inflammation in animal models of PSC and additional fibrosis related indications. CM-101 is being developed as a potential treatment for liver, skin and lung fibrosis-related diseases, such as PSC and systemic sclerosis.

We are excited to see an on-time beginning of enrollment for this study, especially in light of the COVID-19 pandemic and we hope that CM-101 will be proven to help people affected by PSC,” said Adi Mor, PhD, CEO and CSO of Chemomab. “Pre-clinical animal data, as well as liver and serum samples from PSC patients, showed that inhibition of CCL24 by CM-101 interferes with the underlying biology of PSC using a novel and differentiated mechanism of action. We are proud to collaborate with prominent clinical sites such as the Royal Free Hospital in London to establish proof-of-concept for CM-101’s activity for the treatment of PSC, which will then support the design of our future clinical studies for registration,” Dr. Mor concluded.

Principal Investigator of the study, Dr. Douglas Thorburn, Professor of Hepatology, Institute for Liver & Digestive Health, University College London, Royal Free Hospital, London UK stated: “Treatment options for PSC are limited. Pre-clinical studies indicate that the chemokine CCL24 plays a central role in the pathogenesis of PSC. We look forward to explore the therapeutic effect of CM-101 as treatment for PSC in this phase IIa study and we hope to provide effective novel treatment to benefit PSC patients and their families.”

For more information on this clinical study, please visit: www.clinicaltrials.gov, NCT04595825.

About Primary Sclerosing Cholangitis (PSC)

PSC is a rare cholestatic liver disease characterized by inflammation and structuring of the intra- and/or extrahepatic bile ducts that eventually leads to fibrosis, or scarring, of the liver and its bile ducts. The exact cause and disease mechanism of PSC are still unknown, but an autoimmune-fibrotic mechanism may play a role. Patients with PSC are also at significantly increased risk of hepatobiliary cancer and colorectal cancer (CRC), particularly in the 70% of patients who also have IBD. The only therapy with curative potential for PSC is liver transplant. The estimated time from PSC diagnosis to the need for liver transplant has been shown to be less than 15 years.

About CCL24 and CM-101

CCL24 is a soluble protein found to be overexpressed in fibrotic tissues and plays a unique and pivotal role in promoting fibrosis and inflammation. CCL24 induces a dual effect that includes a direct activation of fibroblasts and recruitment of inflammatory cells to damaged tissues.

Chemomab’s lead clinical candidate, CM-101, is a first in class monoclonal antibody targeting CCL24, a novel and differentiated fibrotic target. CM-101 has been shown to substantially attenuate fibrosis and inflammation across a wide range of in-vitro and in-vivo models, including experimental models of primary sclerosing cholangitis (PSC), systemic sclerosis (SSc), idiopathic pulmonary fibrosis (IPF) and nonalcoholic steatohepatitis (NASH).

CM-101 has been shown to be safe and well-tolerated in phase Ia and Ib clinical studies in healthy volunteers and non-alcoholic fatty liver disease (NAFLD) patients and is currently being tested in a phase IIa study in PSC patients. A second phase II study in SSc is planned during 2021.

About Chemomab

Chemomab is a clinical-stage biotech company focusing on the discovery and development of innovative therapeutics for fibrosis-related diseases with a high unmet need. Chemomab is a privately held company supported by leading healthcare-focused investors, including OrbiMed and Peter Thiel. For more information on Chemomab, please visit www.chemomab.com.

Chemomab recently entered into a merger agreement with the Nasdaq-listed company, Anchiano Therapeutics Ltd. (“ANCN”), in which the shareholders of Chemomab would become the majority holders of the combined company. The proposed merger will create a public company focused on advancing Chemomab’s lead product, CM-101, for the treatment of fibrosis-related diseases with high unmet medical need.

SOURCE: ChemomAb