Chemomab Announces Oral Presentation of Positive Nebokitug Phase 2 Clinical Data in Primary Sclerosing Cholangitis at BSG Live’25
Chemomab Therapeutics (Nasdaq: CMMB) presented positive Phase 2 SPRING trial data for nebokitug (CM-101) in primary sclerosing cholangitis (PSC) at BSG Live'25. The data was presented by Principal Investigator Dr. Douglas Thorburn at the British Society for Gastroenterology annual meeting in Glasgow.
The trial demonstrated that nebokitug was well-tolerated over 48 weeks of treatment, with a safety profile comparable to placebo during the initial 15-week double-blind portion. In patients with moderate to advanced disease, the drug showed dose-dependent anti-inflammatory, anti-fibrotic, and anti-cholestatic effects.
The open-label extension portion, lasting up to an additional 33 weeks, revealed sustained improvement in fibrosis markers and other PSC-related parameters. These positive results support advancement to Phase 3 trials, potentially positioning nebokitug as the first approved therapy for PSC.
Chemomab Therapeutics (Nasdaq: CMMB) ha presentato dati positivi della fase 2 dello studio SPRING sul nebokitug (CM-101) nella colangite sclerosante primitiva (PSC) durante il congresso BSG Live'25. I dati sono stati illustrati dal ricercatore principale, il Dr. Douglas Thorburn, all'incontro annuale della British Society for Gastroenterology a Glasgow.
Lo studio ha dimostrato che il nebokitug è stato ben tollerato per 48 settimane di trattamento, con un profilo di sicurezza comparabile al placebo nella fase iniziale in doppio cieco di 15 settimane. Nei pazienti con malattia da moderata a avanzata, il farmaco ha mostrato effetti anti-infiammatori, anti-fibrotici e anti-colestatici dipendenti dalla dose.
La fase di estensione in aperto, durata fino a ulteriori 33 settimane, ha evidenziato un miglioramento sostenuto nei marker di fibrosi e in altri parametri correlati alla PSC. Questi risultati positivi supportano il passaggio alla fase 3, potenzialmente posizionando il nebokitug come la prima terapia approvata per la PSC.
Chemomab Therapeutics (Nasdaq: CMMB) presentó datos positivos del ensayo de fase 2 SPRING con nebokitug (CM-101) en colangitis esclerosante primaria (PSC) en BSG Live'25. Los datos fueron presentados por el investigador principal, el Dr. Douglas Thorburn, en la reunión anual de la British Society for Gastroenterology en Glasgow.
El ensayo demostró que nebokitug fue bien tolerado durante 48 semanas de tratamiento, con un perfil de seguridad comparable al placebo durante la fase inicial doble ciego de 15 semanas. En pacientes con enfermedad moderada a avanzada, el fármaco mostró efectos antiinflamatorios, antifibróticos y anticolestásicos dependientes de la dosis.
La fase de extensión abierta, que duró hasta 33 semanas adicionales, reveló una mejora sostenida en los marcadores de fibrosis y otros parámetros relacionados con la PSC. Estos resultados positivos respaldan el avance a ensayos de fase 3, posicionando potencialmente a nebokitug como la primera terapia aprobada para PSC.
Chemomab Therapeutics (나스닥: CMMB)는 BSG Live'25에서 원발성 경화성 담관염(PSC)에 대한 네보키투그(CM-101)의 2상 SPRING 임상시험 긍정적 데이터를 발표했습니다. 데이터는 글래스고에서 열린 영국 위장병학회 연례회의에서 책임 연구원인 더글라스 손번 박사가 발표했습니다.
임상시험 결과 네보키투그는 48주간의 치료 기간 동안 안전하게 잘 견뎌졌으며, 초기 15주간의 이중맹검 기간 동안 위약과 유사한 안전성 프로파일을 보였습니다. 중등도에서 진행성 질환 환자에서는 용량 의존적인 항염증, 항섬유화 및 항담즙 정체 효과를 나타냈습니다.
최대 33주간 추가로 진행된 공개확장 연구에서는 섬유화 지표 및 기타 PSC 관련 지표의 지속적인 개선이 관찰되었습니다. 이러한 긍정적 결과는 3상 임상시험으로의 진전을 뒷받침하며, 네보키투그가 PSC 최초 승인 치료제로 자리매김할 가능성을 보여줍니다.
Chemomab Therapeutics (Nasdaq : CMMB) a présenté des données positives de l'essai de phase 2 SPRING concernant le nebokitug (CM-101) dans la cholangite sclérosante primitive (PSC) lors du BSG Live'25. Les données ont été présentées par l'investigateur principal, le Dr Douglas Thorburn, lors de la réunion annuelle de la British Society for Gastroenterology à Glasgow.
L'essai a démontré que le nebokitug était bien toléré pendant 48 semaines de traitement, avec un profil de sécurité comparable au placebo durant la phase en double aveugle de 15 semaines. Chez les patients atteints d'une maladie modérée à avancée, le médicament a montré des effets anti-inflammatoires, anti-fibrotiques et anti-cholestatiques dépendants de la dose.
La phase d'extension en ouvert, durant jusqu'à 33 semaines supplémentaires, a révélé une amélioration soutenue des marqueurs de fibrose et d'autres paramètres liés à la PSC. Ces résultats positifs soutiennent la progression vers les essais de phase 3, positionnant potentiellement le nebokitug comme la première thérapie approuvée pour la PSC.
Chemomab Therapeutics (Nasdaq: CMMB) stellte positive Daten der Phase-2-Studie SPRING zu Nebokitug (CM-101) bei primärer sklerosierender Cholangitis (PSC) auf der BSG Live'25 vor. Die Daten wurden vom leitenden Prüfarzt Dr. Douglas Thorburn auf der Jahrestagung der British Society for Gastroenterology in Glasgow präsentiert.
Die Studie zeigte, dass Nebokitug über 48 Wochen gut vertragen wurde und ein Sicherheitsprofil ähnlich wie Placebo während der ersten 15-wöchigen doppelblinden Phase aufwies. Bei Patienten mit mittelschwerer bis fortgeschrittener Erkrankung zeigte das Medikament dosisabhängige antiinflammatorische, antifibrotische und anticholestatische Effekte.
Der offene Verlängerungsabschnitt, der bis zu weitere 33 Wochen dauerte, zeigte eine anhaltende Verbesserung der Fibrosemarker und anderer PSC-bezogener Parameter. Diese positiven Ergebnisse unterstützen den Übergang zu Phase-3-Studien und könnten Nebokitug als die erste zugelassene Therapie für PSC positionieren.
- Nebokitug demonstrated safety and tolerability over 48 weeks of treatment
- Drug showed dose-dependent anti-inflammatory, anti-fibrotic, and anti-cholestatic effects
- Sustained improvement in fibrosis markers observed in open-label extension
- Results support advancement to Phase 3 registration trial
- Potential to become first approved therapy for PSC
- Phase 3 trial success and regulatory approval not guaranteed per risk factors
- Potential challenges in patient enrollment for future trials noted in forward-looking statements
- Possible manufacturing dependencies on third parties highlighted in risk factors
Insights
Chemomab's positive Phase 2 data for nebokitug in PSC shows strong efficacy signals and supports advancement to pivotal Phase 3 trials.
The Phase 2 SPRING trial results for nebokitug (CM-101) mark a significant milestone in Primary Sclerosing Cholangitis (PSC) treatment development. The data demonstrated both safety and efficacy with treatment well-tolerated over 48 weeks and displaying dose-dependent anti-inflammatory, anti-fibrotic, and anti-cholestatic effects.
Most compelling is the consistent biomarker improvement in patients with moderate to advanced disease, suggesting potential disease-modifying capabilities. PSC currently has no FDA-approved treatments, making this development particularly noteworthy in a high-unmet-need indication with potentially fatal outcomes.
The company's advancement to Phase 3 represents a critical value inflection point. As a first-in-class monoclonal antibody targeting CCL24, nebokitug's mechanism differs from other investigational PSC therapies. The presentation by Professor Thorburn, a respected hepatologist, adds credibility to these findings.
From a development perspective, the sustained improvement in fibrosis markers across the 48-week treatment period is particularly encouraging, as PSC progression is characterized by fibrotic biliary strictures. The trial design, including both double-blind placebo-controlled and open-label extension portions, provides robust preliminary evidence of efficacy.
While promising, investors should note that Phase 3 trials require substantial resources and have inherent regulatory risks. However, the positive End-of-Phase 2 meeting mentioned suggests constructive FDA interactions regarding the path forward.
SPRING Trial Data Presented at BSG Live’25 Confirms the Clinical Potential of Nebokitug as a First-in-Class Novel Treatment for PSC and Supports Advancement to Phase 3
Treatment with Nebokitug Is Well-Tolerated and Associated with Substantial Improvements in Multiple Fibrotic and Inflammatory Biomarkers that Represent Slowing of PSC Disease Progression
TEL AVIV, Israel and GLASGOW, United Kingdom, June 30, 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 patients with primary sclerosing cholangitis (PSC) was presented in an oral session1 at BSG Live’25, the annual scientific meeting of the British Society for Gastroenterology, in Glasgow, UK.
The SPRING trial data was presented by Douglas Thorburn, MD, Divisional Clinical Director for Liver and Digestive Health at the Royal Free London NHS Trust and Professor of Hepatology within the Institute for Liver and Digestive Health at UCL, and Principal Investigator of the SPRING trial. Professor Thorburn commented, “PSC is a progressive, potentially fatal disease that lacks effective therapies. The SPRING trial data is very encouraging, showing that nebokitug appears safe and well-tolerated over 48 weeks of treatment. Notably, patients with more active moderate to advanced disease showed sustained improvements in multiple biomarkers associated with PSC disease progression. These findings suggest that nebokitug may have disease-modifying potential in PSC and support advancement to a Phase 3 registration trial.”
The BSG Live’25 session presented data from the double-blind, placebo-controlled portion of the SPRING trial showing that nebokitug was well-tolerated and had a safety profile comparable to placebo over 15 weeks of treatment in patients with PSC, and it demonstrated dose dependent anti-inflammatory, anti-fibrotic and anti-cholestatic effects. In a prespecified subgroup of patients with moderate to advanced disease, patients treated with nebokitug showed broad and consistent improvement in biomarkers that are associated with better clinical outcomes in PSC.
The presentation also noted that data from the open label extension 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 improvement in markers of fibrosis and other parameters associated with PSC.
Adi Mor, PhD, co-founder and Chief Executive Officer of Chemomab, commented, “We are delighted that Professor Thorburn is presenting the results of this important study at this prestigious meeting of British liver and gastroenterology disease experts, who appreciate the enormous unmet need for new therapies for PSC. We continue to advance preparations for initiating the Phase 3 trial that could position nebokitug to become the first approved therapy for this devastating condition.”
1 CM-101, a novel monoclonal antibody targeting CCL24, in patients with primary sclerosing cholangitis: results from SPRING Study, Thorburn D, Barclay S, Joshi D, Trivedi P, Cramp M, Chimakurthi C, Mells G, Culver E, Frankel M, Lawler J, Mor A, BSG Live’25, June 24, Liver session, June 24, 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.
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Media and Investors:
Barbara Lindheim
Consulting Vice President, Investor & Public Relations, Strategic Communications
Phone: +1 917-355-9234
barbara.lindheim@chemomab.com
IR@chemomab.com
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