New analyses from the Phase 2 SPRING trial indicate nebokitug significantly improves biomarkers in PSC, supporting its clinical potential.
Quiver AI Summary
Chemomab Therapeutics announced new findings from the Phase 2 SPRING trial that highlight the potential of their treatment, nebokitug, for primary sclerosing cholangitis (PSC) and other fibro-inflammatory diseases. The analysis showed dose-dependent improvements in various inflammatory and fibrotic biomarkers among patients treated with nebokitug, indicating its effectiveness in targeting disease-related processes. The data, set to be presented as posters at the upcoming EASL 2025 Congress, also demonstrated successful antibody-target engagement and a decrease in PSC-related biomarkers in correlation with increased levels of nebokitug. Chemomab's CEO emphasized the significance of these results in reinforcing nebokitug's role as a first-in-class therapy. The company is preparing for a potential Phase 3 trial based on these encouraging outcomes.
Potential Positives
- New data from the Phase 2 SPRING trial confirm the clinical potential of nebokitug as a first-in-class treatment for primary sclerosing cholangitis (PSC) and other fibro-inflammatory diseases.
- Significant and dose-dependent improvements in multiple inflammatory and fibrotic biomarkers were observed in patients treated with nebokitug, indicating its effectiveness.
- Nebokitug's mechanism of action, demonstrated through comprehensive proteomic analyses, showcases its ability to neutralize CCL24 and positively affect disease-related pathways.
- The company is preparing for a potential Phase 3 trial based on positive Phase 2 results, which aligns with regulatory pathways for full approval following FDA and EMA Orphan Drug and FDA Fast Track designations.
Potential Negatives
- The press release contains multiple forward-looking statements, indicating significant risks and uncertainties related to the company's ability to secure regulatory approvals for nebokitug and the potential for future clinical trials to yield consistent results, which could adversely affect investor confidence.
- The acknowledgment of potential delays in clinical trials and the ability to enroll patients raises concerns about the company's operational efficiency and its capacity to advance drug development timelines.
- The impact of the ongoing war in Israel is cited as a risk factor that could affect operations, which may lead to instability and uncertainty surrounding the company's future activities and growth prospects.
FAQ
What are the key findings from the Phase 2 SPRING trial?
The trial showed dose-dependent improvements in inflammatory and fibrotic biomarkers in PSC patients treated with nebokitug.
How does nebokitug work for PSC treatment?
Nebokitug neutralizes the CCL24 protein, impacting inflammatory and fibrotic pathways associated with PSC and other fibro-inflammatory diseases.
What is the significance of the EASL 2025 presentation?
The EASL 2025 presentation will share new insights from comprehensive proteomic analyses supporting nebokitug’s clinical potential as a treatment.
What regulatory designations has nebokitug received?
Nebokitug has received FDA and EMA Orphan Drug and FDA Fast Track designations for treating primary sclerosing cholangitis (PSC).
Where can I find the EASL 2025 posters?
Copies of the EASL 2025 posters will be available on the R&D pages of the Chemomab website after their presentation dates.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
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
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding our future financial condition, results of operations, business strategy and plans, and objectives of management for future operations, as well as statements regarding industry trends, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “estimate,” “intend,” “may,” “plan,” “potentially,” “will” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: the risk that certain acknowledgements from the End-of-Phase 2 (EOP2) meeting with the FDA in connection with PSC regulatory approval will not materialize into a pathway for regulatory approval; that certain conclusions and assumptions drawn from the EOP2 meeting with the FDA discussed in the press release will prove incorrect and adversely affect the ability for nebokitug to become an FDA fully approved therapy; the risk that the full data set from the nebokitug study or data generated in further clinical trials of nebokitug will not be consistent with the topline results of the nebokitug Phase 2 PSC trial; failure to obtain, or delays in obtaining, regulatory approvals for nebokitug in the U.S., Europe or other territories; failure to successfully commercialize nebokitug, if approved by applicable regulatory authorities, in the U.S., Europe or other territories, or to maintain U.S., European or other territory regulatory approval for nebokitug if approved; uncertainties in the degree of market acceptance of nebokitug by physicians, patients, third-party payors and others in the healthcare community; nebokitug development of unexpected safety or efficacy concerns related to nebokitug; failure to successfully conduct future clinical trials for nebokitug, including due to the Company's potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval, among other things; risks that the Company's clinical studies will be delayed or that serious side effects will be identified during drug development; failure of third parties on which the Company is dependent to manufacture sufficient quantities of nebokitug for commercial or clinical needs, to conduct the Company's clinical trials; changes in laws and regulations applicable to the Company's business and failure to comply with such laws and regulations; business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises; and uncertainties with respect to the Company's need and ability to access future capital; and the intensity and duration of the current war in Israel, and its impact on our operations in Israel. These risks are not exhaustive. You should carefully consider the risks and uncertainties described in the “Risk Factors” sections of our 20-F for the year ended December 31, 2024. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this press release. Before you invest, you should read the documents we have filed and will file with the SEC for more complete information about us. You may get these documents for free by visiting EDGAR on the SEC website at
www.sec.gov
. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities law of any such state or jurisdiction.
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
.
Contact:
Media and Investors:
Barbara Lindheim
Consulting Vice President, Investor & Public Relations, Strategic Communications
Phone: +1 917-355-9234
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