Benzinga | Dec 2, 2021 07:08AM EST

Chemomab Announced FDA Clearance of Its IND Application for CM-101, a First-In-Class CCL24 Neutralizing Antibody for the Treatment of Primary Sclerosing Cholangitis

Chemomab Therapeutics, Ltd. (NASDAQ:CMMB) (Chemomab), a clinical-stage biotech company focused on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet need, today announced that the U.S. Food and Drug Administration ("FDA") has cleared the company's Investigational New Drug ("IND") application for CM-101, a first-in-class CCL24-neutralizing antibody for the treatment of the rare disease primary sclerosing cholangitis (PSC). The Phase 2 SPRING trial assessing CM-101 as a potential treatment for PSC is already underway in Europe and Israel and is now being expanded to include U.S. sites.

Chemomab Logo"FDA clearance of the IND for our first U.S. clinical trial is an important milestone for Chemomab," said Adi Mor, PhD, co-founder and Chief Scientific Officer of Chemomab. "This clearance allows us to significantly increase the number of clinical sites in our Phase 2 SPRING study, as we augment our development capabilities and expand our clinical and business presence in the U.S."

Chemomab's SPRING trial is a Phase 2 multicenter, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of CM-101 over 15 weeks of treatment in patients with PSC. The trial will include clinical sites in the U.S., U.K., E.U. and Israel. The initial clinical readout is expected in 2022.

For more information on the SPRING trial in primary sclerosing cholangitis, see ClinicalTrials.gov using the identifier: NCT04595825.