Chemomab Reports New Positive Clinical Data at EASL 2025 Supporting Nebokitug’s Impact in Primary Sclerosing Cholangitis and Related Diseases
Chemomab Therapeutics (Nasdaq: CMMB) has presented new positive clinical data at EASL 2025 supporting nebokitug's potential as a first-in-class treatment for Primary Sclerosing Cholangitis (PSC) and related fibro-inflammatory diseases.
The Phase 2 SPRING trial analysis revealed that nebokitug treatment resulted in dose-dependent improvements in multiple inflammatory and fibrotic biomarkers. A comprehensive proteomic analysis of 3,000 circulating proteins showed significant changes in proteins related to fibrosis, immune cell recruitment, and inflammation. The treatment led to downregulation of biological processes including cell-cell adhesion, extracellular matrix organization, and pathways involved in leukocyte migration.
Pharmacokinetic analyses demonstrated dose-proportional increases in nebokitug concentration, with steady-state levels achieved after the fourth dose. Linear regression analyses indicated trends between increasing patient exposure to nebokitug and decreasing levels of PSC disease biomarkers, including liver enzyme and transient elastography scores.
Chemomab Therapeutics (Nasdaq: CMMB) ha presentato nuovi dati clinici positivi all'EASL 2025, che supportano il potenziale di nebokitug come trattamento innovativo per la Colangite Sclerosante Primaria (PSC) e le malattie fibro-infiammatorie correlate.
L'analisi dello studio di Fase 2 SPRING ha mostrato che il trattamento con nebokitug ha determinato miglioramenti dipendenti dalla dose in diversi biomarcatori infiammatori e fibrotici. Un’analisi proteomica completa di 3.000 proteine circolanti ha evidenziato cambiamenti significativi nelle proteine coinvolte nella fibrosi, nel reclutamento delle cellule immunitarie e nell’infiammazione. Il trattamento ha portato a una regolazione al ribasso di processi biologici quali l’adesione cellula-cellula, l’organizzazione della matrice extracellulare e le vie di migrazione dei leucociti.
Le analisi farmacocinetiche hanno dimostrato un aumento proporzionale alla dose della concentrazione di nebokitug, con livelli stazionari raggiunti dopo la quarta somministrazione. Le analisi di regressione lineare hanno indicato una correlazione tra l’aumento dell’esposizione al farmaco e la diminuzione dei biomarcatori della PSC, inclusi gli enzimi epatici e i punteggi dell’elastografia transitoria.
Chemomab Therapeutics (Nasdaq: CMMB) ha presentado nuevos datos clínicos positivos en EASL 2025 que respaldan el potencial de nebokitug como un tratamiento pionero para la Colangitis Esclerosante Primaria (PSC) y enfermedades fibroinflamatorias relacionadas.
El análisis del ensayo de Fase 2 SPRING reveló que el tratamiento con nebokitug resultó en mejoras dependientes de la dosis en múltiples biomarcadores inflamatorios y fibróticos. Un análisis proteómico exhaustivo de 3,000 proteínas circulantes mostró cambios significativos en proteínas relacionadas con la fibrosis, el reclutamiento de células inmunitarias y la inflamación. El tratamiento condujo a una regulación a la baja de procesos biológicos como la adhesión célula-célula, la organización de la matriz extracelular y las vías implicadas en la migración de leucocitos.
Los análisis farmacocinéticos demostraron incrementos proporcionales a la dosis en la concentración de nebokitug, alcanzando niveles en estado estacionario después de la cuarta dosis. Los análisis de regresión lineal indicaron tendencias entre el aumento de la exposición al medicamento y la disminución de los niveles de biomarcadores de la PSC, incluidos enzimas hepáticos y puntuaciones de elastografía transitoria.
Chemomab Therapeutics (나스닥: CMMB)는 EASL 2025에서 원발성 경화성 담관염(PSC) 및 관련 섬유염증성 질환에 대한 최초의 혁신적 치료제로서 네보키투그의 잠재력을 뒷받침하는 새로운 긍정적 임상 데이터를 발표했습니다.
2상 SPRING 임상시험 분석 결과, 네보키투그 치료는 여러 염증 및 섬유화 바이오마커에서 용량 의존적 개선을 나타냈습니다. 3,000개의 순환 단백질에 대한 포괄적 단백질체 분석은 섬유화, 면역세포 모집 및 염증과 관련된 단백질에서 유의미한 변화를 보여주었습니다. 치료는 세포 간 부착, 세포외 기질 조직화, 백혈구 이동 경로 등 생물학적 과정의 하향 조절을 초래했습니다.
약동학 분석에서는 네보키투그 농도가 용량에 비례하여 증가하며, 네 번째 투여 후 안정 상태에 도달함을 확인했습니다. 선형 회귀 분석에서는 환자의 네보키투그 노출 증가와 PSC 질환 바이오마커(간 효소 및 일시적 탄성측정 점수)의 감소 간에 추세가 관찰되었습니다.
Chemomab Therapeutics (Nasdaq : CMMB) a présenté de nouvelles données cliniques positives lors de l’EASL 2025, soutenant le potentiel de nebokitug en tant que traitement innovant de première classe pour la Cholangite Sclérosante Primitive (PSC) et les maladies fibro-inflammatoires associées.
L’analyse de l’essai de phase 2 SPRING a révélé que le traitement par nebokitug entraînait des améliorations dépendantes de la dose de plusieurs biomarqueurs inflammatoires et fibrosants. Une analyse protéomique complète de 3 000 protéines circulantes a montré des changements significatifs dans les protéines liées à la fibrose, au recrutement des cellules immunitaires et à l’inflammation. Le traitement a conduit à une régulation à la baisse des processus biologiques tels que l’adhésion cellulaire, l’organisation de la matrice extracellulaire et les voies impliquées dans la migration des leucocytes.
Les analyses pharmacocinétiques ont démontré des augmentations proportionnelles à la dose de la concentration de nebokitug, avec des niveaux à l’état stable atteints après la quatrième dose. Les analyses de régression linéaire ont indiqué des tendances entre l’augmentation de l’exposition au médicament et la diminution des niveaux des biomarqueurs de la PSC, y compris les enzymes hépatiques et les scores d’élastographie transitoire.
Chemomab Therapeutics (Nasdaq: CMMB) hat auf der EASL 2025 neue positive klinische Daten vorgestellt, die das Potenzial von Nebokitug als neuartige Erstbehandlung für Primär Sklerosierende Cholangitis (PSC) und verwandte fibroinflammatorische Erkrankungen unterstützen.
Die Analyse der Phase-2-Studie SPRING zeigte, dass die Behandlung mit Nebokitug dosisabhängige Verbesserungen bei mehreren entzündlichen und fibrotischen Biomarkern bewirkte. Eine umfassende proteomische Analyse von 3.000 zirkulierenden Proteinen zeigte signifikante Veränderungen bei Proteinen, die mit Fibrose, Immunzellrekrutierung und Entzündung in Zusammenhang stehen. Die Behandlung führte zu einer Herunterregulierung biologischer Prozesse wie Zell-Zell-Adhäsion, Organisation der extrazellulären Matrix und Signalwege, die an der Leukozytenmigration beteiligt sind.
Pharmakokinetische Analysen zeigten dosisproportionale Anstiege der Nebokitug-Konzentration, wobei nach der vierten Dosis ein stabiler Zustand erreicht wurde. Lineare Regressionsanalysen deuteten auf einen Zusammenhang zwischen zunehmender Patientenaussetzung gegenüber Nebokitug und sinkenden PSC-Biomarkerwerten hin, einschließlich Leberenzymen und transienten Elastographie-Werten.
- Phase 2 SPRING trial showed dose-dependent improvements in multiple inflammatory and fibrotic biomarkers
- Demonstrated effective antibody-target engagement with dose-proportional increases
- Treatment led to decreased levels of PSC disease biomarkers including liver enzyme scores
- Comprehensive analysis of 3,000 proteins showed significant therapeutic impact
- Full regulatory approval pathway not yet established
- Potential risks of inconsistent results in future clinical trials
- Uncertainties regarding market acceptance by physicians and patients
- Possible challenges in patient enrollment for future trials
Insights
Chemomab's Phase 2 data shows nebokitug significantly affects multiple inflammation and fibrosis biomarkers, demonstrating promising mechanism for treating PSC.
The new proteomic analyses from Chemomab's Phase 2 SPRING trial provide compelling biological evidence supporting nebokitug's mechanism of action in PSC patients. By examining 3,000 circulating proteins, researchers demonstrated that nebokitug treatment produces dose-dependent changes in multiple proteins central to disease pathology. Particularly noteworthy is the downregulation of biological processes related to fibrosis (extracellular matrix organization), inflammation, and critical molecular functions including growth factor and integrin binding.
The pharmacokinetic data further strengthens the scientific case by showing dose-proportional increases in nebokitug concentration with steady-state achieved after the fourth dose. This corresponds with increased levels of CCL24 (the drug's target), confirming effective antibody-target engagement. The observed correlation between nebokitug exposure and decreases in liver enzymes and transient elastography scores provides a mechanistic link between the drug's activity and potential clinical benefit.
This comprehensive dataset reveals how nebokitug's specific CCL24 blockade mechanism produces broad downstream effects across multiple inflammatory and fibrotic pathways. This is particularly significant for PSC, a disease with no approved therapies where targeting underlying mechanisms rather than symptoms represents a novel approach. The multiple affected biomarkers also explain why the company is pursuing applications beyond PSC in other fibro-inflammatory conditions with similar pathological pathways.
New Phase 2 biomarker data strengthens nebokitug's development case for PSC, showing meaningful biological activity through multiple pathways.
The biomarker data presented from Chemomab's Phase 2 SPRING trial significantly strengthens the clinical development case for nebokitug in PSC. The results demonstrate that the drug is not just hitting its CCL24 target but producing meaningful biological activity across multiple disease-relevant pathways. The downregulation of proteins involved in leukocyte migration, cytokine activity, chemokine activity, and collagen binding addresses core mechanisms underlying PSC pathophysiology.
From a clinical development perspective, the pharmacodynamic data showing correlation between drug exposure and improvement in liver enzymes and elastography scores is particularly valuable. These are established markers of liver disease that regulators consider relevant. The dose-dependent responses observed across multiple biomarkers also suggest proper dose selection for future studies.
For PSC - a rare liver disease with no FDA-approved therapies - these findings represent meaningful progress. The comprehensive proteomic analysis provides a strong scientific foundation that supports advancing nebokitug's development. While these are Phase 2 results focused on biomarkers rather than definitive clinical outcomes, they provide multiple lines of evidence supporting the drug's therapeutic potential. The breadth of affected pathways also supports the company's strategy to explore nebokitug in multiple fibro-inflammatory conditions, potentially expanding its clinical utility beyond PSC.
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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Barbara Lindheim
Consulting Vice President, Investor & Public Relations, Strategic Communications
Phone: +1 917-355-9234
barbara.lindheim@chemomab.com
IR@chemomab.com
FAQ
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