New Analyses of PSC Data from Phase 2 SPRING Trial Show that Treatment with Nebokitug Is Associated with Dose-Dependent and Significant Improvements in Multiple Inflammatory and Fibrotic Biomarkers
Further Confirms the Clinical Potential of Nebokitug As a First-in-Class Novel Treatment for PSC and Other Fibro-Inflammatory Conditions
Second EASL 2025 Poster Reports that Pharmacokinetic and Pharmacodynamic Data from the Phase 2 Spring Trial Demonstrates Effective and Dose-Dependent Antibody-Target Engagement
TEL AVIV, Israel, April 28, 2025 (GLOBE NEWSWIRE) -- Chemomab Therapeutics, Ltd., (Nasdaq: CMMB), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, today reported data from two study abstracts that will be presented as posters at EASL 2025, the Annual Congress of the European Association for the Study of the Liver, that will be held May 7–10, 2025, in Amsterdam, the Netherlands.
Adi Mor, PhD, co-founder and Chief Executive Officer of Chemomab, commented, “This new clinical data further confirms the potential of nebokitug (CM-101) as a first-in-class treatment for primary sclerosing cholangitis (PSC) and other fibro-inflammatory diseases. The comprehensive proteomic analyses we are presenting at EASL 2025 indicate that treatment with nebokitug resulted in additional improvements in a wide variety of biomarkers that are broadly related to fibro-inflammatory disease pathways including in PSC, inflammatory bowel disease, and inflammation and fibrosis in general.”
Comprehensive proteomic analyses of 3,000 circulating proteins in patient samples from the Phase 2 SPRING trial in patients with PSC showed that nebokitug-treated patients exhibited significant and dose-dependent changes in multiple proteins, including those playing a key role in fibrosis, immune cell recruitment and inflammation.1 The analysis provided new insights into PSC disease-related pathways and additional biological evidence of the clinical activity of nebokitug. Nebokitug-treated patients showed downregulation of biological processes related to fibrosis and inflammation, such as cell-cell adhesion and extracellular matrix organization, as well as to molecular functions including binding of growth factors and integrins.
Treatment with nebokitug was also linked to the downregulation of disease-related proteins and pathways involved with leukocyte migration, cytokine activity, chemokine activity and collagen binding. The authors highlight how nebokitug’s ability to neutralize its CCL24 target exerts a wide impact, as demonstrated by the reductions in a broad array of inflammatory and fibrotic biomarkers in treated patients.
The second abstract presents an analysis of the pharmacodynamics and pharmacokinetics (PK) of nebokitug and CCL24 using patient data from the Phase 2 SPRING trial in patients with PSC.2 PK analyses indicated dose-proportional increases in the concentration of nebokitug with steady-state levels achieved after the fourth dose. These increased levels of nebokitug corresponded with increased levels of nebokitug’s CCL24 target, reflecting effective antibody-target engagement that was dose-dependent between the two treatment groups. Importantly, linear regression analyses found trends between increasing patient exposure to nebokitug and decreasing levels of relevant PSC disease biomarkers, including liver enzyme and transient elastography scores.
Copies of the EASL 2025 posters will be available at the R&D pages of the Chemomab website starting on the date they are presented.
1 CCL24 blockade alters the proteomic profile of patients with primary sclerosing cholangitis and down-regulates central disease processes, T Snir, R Greenman, R Aricha, I Vaknin, M Frankel, J Lawler, A Mor, EASL 2025 Abstract #1243, May 9, 2025
2 CM-101 impacts disease biomarkers in primary sclerosing cholangitis: assessment of the SPRING study pharmacokinetics and pharmacodynamics, M Frankel, J Lawler, I Vaknin, A Mor, EASL 2025 Abstract #1255, May 8, 2025
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About Chemomab Therapeutics Ltd.
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 and has demonstrated disease-modifying potential. In clinical and preclinical studies, nebokitug has been shown to have a favorable safety profile and has been generally well-tolerated, with the potential to treat multiple severe and life-threatening fibro-inflammatory diseases. Chemomab has reported positive results from four clinical trials of nebokitug in patients. Based on positive data from its Phase 2 SPRING trial in primary sclerosing cholangitis (PSC), the company is preparing for potential initiation of a nebokitug PSC Phase 3 trial. The design of Phase 3 calls for a single pivotal trial based on a clinical event primary endpoint that provides a clear and streamlined pathway to potential full regulatory approval. Nebokitug has received FDA and EMA Orphan Drug and FDA Fast Track designations for the treatment of PSC. Chemomab’s nebokitug program for the treatment of systemic sclerosis has an open U.S. IND. For more information, visit: chemomab.com.
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