Chemomab Announces Presentation of Positive Nebokitug Phase 2 Clinical Data in Primary Sclerosing Cholangitis in Distinguished Plenary Session at DDW 2025
SPRING Trial Data Presented at Digestive Disease Week® 2025 Shows that Nebokitug at 15 and 48 Weeks of Treatment Is Well-Tolerated and Associated with Significant Improvements in Multiple Fibrotic and Inflammatory Biomarkers that Represent Slowing of Disease Progression
Confirms the Clinical Potential of Nebokitug As a First-in-Class Novel Treatment for PSC and Supports Advancement to Phase 3
TEL AVIV, Israel and SAN DIEGO, May 05, 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 announced that data from the company's Phase 2 SPRING trial of nebokitug (CM-101) in primary sclerosing cholangitis (PSC)1 was presented in an oral Distinguished Abstract Plenary session at Digestive Disease Week® (DDW 2025) in San Diego, California.
Paul J. Pockros, MD, Director, Liver Disease Center Scripps Clinic and Director of SC Liver Research Consortium, who was a SPRING trial investigator, presented the nebokitug data. He noted, "PSC is a potentially devastating progressive disease that lacks any FDA-approved therapies. The data from the SPRING trial are very encouraging, showing that nebokitug appears safe and well-tolerated over 48 weeks of treatment. Notably, patients with more active moderate to severe disease showed sustained improvements in multiple biomarkers associated with disease progression. We believe these findings suggest that nebokitug may have disease-modifying potential and support developing nebokitug 20 mg/kg in a Phase 3 clinical study in patients with PSC."
The DDW 2025 session presented data from the double-blind, placebo-controlled 15-week treatment period showing that nebokitug was well-tolerated and had a safety profile comparable to placebo. Nebokitug demonstrated dose dependent anti-inflammatory, anti-fibrotic and anti-cholestatic effects in patients with PSC. In a prespecified subgroup of patients with moderate to advanced disease, patients treated with nebokitug showed broad and consistent improvement in biomarkers that have been associated with better clinical outcomes.
The presentation also included data from the open label extension portion of the study, in which all eligible study patients received nebokitug for up to an additional 33 weeks. This data 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 sustained and continual reduction in ELF scores, especially in patients with moderate to advanced disease receiving the 20 mg/kg dose. Patients also experienced stabilization of liver stiffness as measured by transient elastography, especially in those with moderate to advanced disease receiving the 20 mg/kg dose.
Adi Mor, PhD, co-founder and Chief Executive Officer of Chemomab, commented, "We believe the nebokitug SPRING trial data are the strongest to date in this debilitating and potentially lethal disease that lacks effective treatment. We are pleased that these positive data were featured at a major multi-disciplinary medical meeting like DDW 2025, as we continue to assess the best options for advancing nebokitug to a Phase 3 trial."
A copy of the DDW 2025 presentation is now available at the R&D pages of the Chemomab website.
1 CM-101, a novel monoclonal antibody targeting CCL24, was safe, well-tolerated and showed improvements of biomarkers associated with inflammation, fibrosis and cholestasis in patients wit primary sclerosing cholangitis: the SPRING study, CL Bowlus, ST Barclay, D Joshi, MC Londoño, P Mantry, PJ Pockros, R Safadi, R Aricha, C Cirillo, M Frankel, J Lawler, I Vaknin, A Mor, D Thorburn on behalf of the SPRING Study Investigators, DDW 2025, Liver & Biliary Section Distinguished Abstract Plenary, May 4, 2025
Forward-Looking Statements
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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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