Chemomab Receives FDA Clearance for Phase 2 Trial
Clinical-stage biotechnology company, Chemomab (Nasdaq: CMMB) has received clearance from the FDA for its Investigational New Drug (IND) Application to evaluate CM-101 in a Phase 2 trial in adults with systemic sclerosis (SSc).
CM-101 is a first-in-class monoclonal antibody designed to interfere with key biological pathways associated with SSc and other serious fibro-inflammatory diseases. In early clinical trials, CM-101 was well-tolerated and demonstrated anti-inflammatory effects and a reduction in fibrogenesis-related biomarkers.
- CM-101 has been granted Orphan Drug designation by the FDA for SSc and for primary sclerosing cholangitis (PSC), a rare liver disease.
- The company’s Phase 2 ABATE trial will enroll 45 patients with clinically active dermatologic, vascular or pulmonary SSc.
- The trial is a multicenter, randomized, double-blind, proof-of-biology study designed to further assess safety and establish biological and clinical proof-of-concept for CM-101 as a potential treatment for patients with SSc.
- A top-line data read-out is planned for the second half of 2024.
Chemomab is focused on the discovery and development of therapeutics for fibro-inflammatory diseases with high unmet need.