FDA Fast Track for Chemomab’s Liver Disease Treatment; Shares Surge 50%
Chemomab Therapeutics Ltd. (Nasdaq: CMMB) has received FDA Fast Track Designation for CM-101 for the treatment of primary sclerosing cholangitis (PSC). PSC is a progressive, fibrotic liver disease that can result in liver transplant, cancer and early death. It has no cure and no FDA-approved treatments. The company’s share price was up by more than 50% in trading on Wednesday.
Adi Mor, PhD, co-founder, Chief Executive Officer and Chief Scientific Officer of Chemomab, said, “This FDA Fast Track designation is an important validation of CM-101’s potential to have a major impact on this devastating disease that attacks people in their prime years and lacks any approved treatments. We welcome the enhanced opportunities for working closely with the FDA and for acceleration of the development and review process provided by Fast Track status.”
Highlights
Chemomab’s Phase 2 SPRING trial is a double-blind, placebo-controlled study assessing the safety and tolerability of CM-101 in PSC patients.
Patient enrollment in the trial is advancing towards completion and Chemomab anticipates reporting a top-line readout in the second half of 2024.
CM-101 is a monoclonal antibody that neutralizes CCL24, a soluble protein that helps drive the inflammatory and fibrotic pathways central to many fibro-inflammatory diseases.
PSC is a rare, progressive liver disease, characterized by inflammation and fibrosis (scarring) of the bile ducts. Eventually, it can lead to cirrhosis of the liver and liver failure.
Fast Track is a process developed by the FDA to facilitate and expedite the development of new treatments that demonstrate a potential to address unmet medical needs in serious or life-threatening conditions.
About Chemomab Therapeutics
Chemomab is a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need. Based on the unique and pivotal role of CCL24 in promoting fibrosis and inflammation, Chemomab developed CM-101, a monoclonal antibody designed to neutralize CCL24 activity. In preclinical and clinical studies, CM-101 appears safe, with the potential to treat multiple severe and life-threatening fibro-inflammatory diseases. Chemomab has reported encouraging results from three clinical trials of CM-101 in patients, including a Phase 1b trial in NAFLD patients, a Phase 2a liver fibrosis trial in NASH patients and an investigator-initiated study in patients with severe lung injury. The CM-101 program for the treatment of systemic sclerosis is Phase 2-ready and a Phase 2 trial in primary sclerosing cholangitis patients is ongoing, with top-line data expected in the second half of 2024. For more information about Chemomab, visit chemomab.com.
