About Chemomab
Company Overview
Pioneering Innovative Treatments for Fibro-inflammatory Diseases
Chemomab is a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need. Based on the unique role of the soluble protein CCL24 in promoting fibrosis and inflammation, Chemomab developed nebokitug (CM-101), a first-in-class dual activity monoclonal antibody that neutralizes CCL24 activity and addresses the high unmet need for effective treatments for fibrotic diseases. In preclinical studies, treatment with nebokitug demonstrated strong anti-fibrotic effects, reduced inflammatory injury and significantly improved organ damage. Numerous in-vivo, in-vitro and ex-vivo studies showed that nebokitug demonstrated potent anti-CCL24 effects in disease models of primary sclerosing cholangitis (PSC), systemic sclerosis (SSc), idiopathic pulmonary fibrosis (IPF) and metabolic dysfunction-associated steatohepatitis (MASH).
In five clinical studies to date, CM-101 appears safe and well tolerated in both healthy subjects and in patients who received either intravenous or subcutaneous administrations.
Based on nebokitug’s broad, robust biological effects, favorable tolerability profile and unique mechanism of action, Chemomab believes nebokitug may have the potential to interrupt the deleterious pathological processes that drive fibro-inflammatory diseases, with the potential to become an effective anti-fibrotic therapeutic agent with disease-modifying potential.
In a Phase 2a liver fibrosis trial of nebokitug in MASH patients, nebokitug was safe and well-tolerated and treated patients showed consistent and positive improvements across a number of fibro-inflammatory biomarkers. Results from the double-blind, placebo-controlled portion of the nebokitug Phase 2 SPRING trial in patients with PSC show that nebokitug met the primary study endpoint, demonstrating a favorable safety profile over the 15-week treatment period. Nebokitug -treated patients with moderate/advanced disease showed improvements on a wide range of disease-related secondary endpoints, including assessments of changes from baseline relative to placebo at Week 15 in liver stiffness; in liver fibrosis biomarkers, including the Enhanced Liver Fibrosis (ELF) score and PRO-C3 levels; in total bilirubin and liver function tests; in pruritus (itch) and in markers of inflammation. Dose-dependent responses were observed for multiple disease-related biomarkers. A consistent pattern of greater improvement on the secondary endpoints was observed in the study arm receiving the higher 20 mg/kg dose of nebokitug and in the prespecified subgroup of PSC patients with moderate/advanced disease. Data from the open label extension (OLE) portion of the trial, in which all eligible participants received nebokitug for up to an additional 33 weeks, showed that nebokitug was safe and well-tolerated for up to 48 weeks of treatment. Patients treated with nebokitug showed sustained or continual improvement in markers of fibrosis and stabilization of liver stiffness as measured by transient elastography.
The nebokitug SSc program has an open U.S. IND.
Nebokitug has Orphan Drug designation in the U.S. and European Union and received Fast Track designation for the treatment of PSC in adults from the U.S. Food and Drug Administration (FDA).