Oral Presentation at AASLD The Liver Meeting® 2024 Highlights Broad Clinical Activity of Chemomab’s CM-101 Across Multiple Biomarkers and Its Disease-Modifying Potential in Primary Sclerosing Cholangitis
Chemomab Therapeutics presented Phase 2 SPRING trial data for CM-101 in primary sclerosing cholangitis (PSC) at AASLD The Liver Meeting® 2024. The trial, involving 76 patients, tested two doses (10 mg/kg and 20 mg/kg) administered every three weeks over 15 weeks. CM-101 met its primary safety endpoint and showed dose-dependent improvements across multiple biomarkers. The higher 20 mg/kg dose demonstrated greater improvements, particularly in patients with moderate/advanced disease, showing anti-fibrotic, anti-inflammatory, and anti-cholestatic effects. Key improvements were observed in liver stiffness, ELF scores, PRO-C3 levels, liver biochemistries, bilirubin levels, and pruritus scores.
Chemomab Therapeutics ha presentato i dati del trial di Fase 2 SPRING per CM-101 nella colangite sclerosante primaria (PSC) durante l'AASLD The Liver Meeting® 2024. Lo studio, che ha coinvolto 76 pazienti, ha testato due dosi (10 mg/kg e 20 mg/kg) somministrate ogni tre settimane per un totale di 15 settimane. CM-101 ha raggiunto il suo obiettivo primario di sicurezza e ha mostrato miglioramenti dose-dipendenti in vari biomarcatori. La dose maggiore di 20 mg/kg ha dimostrato miglioramenti maggiori, in particolare nei pazienti con malattia moderata/avanzata, mostrando effetti anti-fibrotici, anti-infiammatori e anti-colocatici. Sono stati osservati miglioramenti chiave nella rigidità epatica, nei punteggi ELF, nei livelli di PRO-C3, nelle biochimiche epatiche, nei livelli di bilirubina e nei punteggi di prurito.
Chemomab Therapeutics presentó los datos del ensayo de Fase 2 SPRING para CM-101 en colangitis esclerosante primaria (PSC) en AASLD The Liver Meeting® 2024. El ensayo, que involucró a 76 pacientes, probó dos dosis (10 mg/kg y 20 mg/kg) administradas cada tres semanas durante 15 semanas. CM-101 cumplió con su objetivo primario de seguridad y mostró mejoras dependientes de la dosis en múltiples biomarcadores. La dosis más alta de 20 mg/kg demostró mayores mejoras, particularmente en pacientes con enfermedad moderada/avanzada, mostrando efectos anti-fibróticos, anti-inflamatorios y anti-colestásicos. Se observaron mejoras clave en la rigidez hepática, en las puntuaciones ELF, en los niveles de PRO-C3, en las bioquímicas hepáticas, en los niveles de bilirrubina y en las puntuaciones de prurito.
Chemomab Therapeutics는 AASLD The Liver Meeting® 2024에서 CM-101의 원발성 경화성 담관염 (PSC)에 대한 2상 SPRING 시험 데이터를 발표했습니다. 이 시험은 76명의 환자를 대상으로 하여 3주마다 10 mg/kg 및 20 mg/kg의 두 가지 용량을 15주 동안 투여했습니다. CM-101은 주요 안전성 목표를 충족했으며 여러 바이오마커에서 용량 의존적인 개선을 보였습니다. 더 높은 20 mg/kg 용량은 특히 중등도/진행성 질환 환자에서 더 큰 개선을 보여주며 항 섬유화, 항 염증 및 항 담즙 정체 효과를 나타냈습니다. 간 경직도, ELF 점수, PRO-C3 수치, 간 생화학, 빌리루빈 수치 및 가려움증 점수에서 주요 개선 사항이 관찰되었습니다.
Chemomab Therapeutics a présenté les données de l'essai de phase 2 SPRING pour CM-101 dans la cholangite sclérosante primitive (PSC) lors de l'AASLD The Liver Meeting® 2024. L'essai, impliquant 76 patients, a testé deux doses (10 mg/kg et 20 mg/kg) administrées toutes les trois semaines pendant 15 semaines. CM-101 a atteint son objectif de sécurité principal et a montré des améliorations dépendantes de la dose dans plusieurs biomarqueurs. La dose plus élevée de 20 mg/kg a montré de plus grandes améliorations, en particulier chez les patients atteints de maladies modérées/avancées, montrant des effets anti-fibrotiques, anti-inflammatoires et anti-cholestatiques. Des améliorations clés ont été observées dans la rigidité hépatique, les scores ELF, les niveaux de PRO-C3, les biochimiques hépatiques, les niveaux de bilirubine et les scores de prurit.
Chemomab Therapeutics hat auf der AASLD The Liver Meeting® 2024 Daten zur Phase-2-Studie SPRING für CM-101 bei primärer sklerosierender Cholangitis (PSC) vorgestellt. Die Studie umfasste 76 Patienten und testete zwei Dosen (10 mg/kg und 20 mg/kg), die alle drei Wochen über einen Zeitraum von 15 Wochen verabreicht wurden. CM-101 erreichte sein primäres Sicherheitsziel und zeigte dosierungsabhängige Verbesserungen in mehreren Biomarkern. Die höhere Dosis von 20 mg/kg zeigte größere Verbesserungen, insbesondere bei Patienten mit moderater/fortgeschrittener Erkrankung, und zeigte anti-fibrotische, anti-inflammatorische und anti-cholestatische Effekte. Wichtige Verbesserungen wurden bei der Lebersteifigkeit, den ELF-Werten, den PRO-C3-Spiegeln, den Leberbiochemien, den Bilirubinwerten und den Juckreiz-Scores beobachtet.
- Met primary safety endpoint with favorable safety profile
- Demonstrated dose-dependent improvements across multiple disease biomarkers
- Showed significant liver stiffness improvement in moderate/advanced disease patients
- Achieved statistically significant reductions in fibrosis-related markers
- Demonstrated anti-inflammatory, anti-fibrotic, and anti-cholestatic effects
- None.
Insights
The Phase 2 SPRING trial results for CM-101 in Primary Sclerosing Cholangitis (PSC) demonstrate significant therapeutic potential. The drug showed dose-dependent improvements across multiple critical biomarkers, particularly at the higher 20 mg/kg dose. Key findings include improved liver stiffness, reduced fibrosis markers (ELF scores, PRO-C3), better liver biochemistries and decreased bilirubin levels.
The most compelling data comes from patients with moderate/advanced disease, suggesting CM-101's potential effectiveness in more severe cases. The drug's unique triple action - anti-fibrotic, anti-inflammatory and anti-cholestatic effects - sets it apart in the PSC treatment landscape. With a favorable safety profile and plans for a registrational trial, CM-101 could become a first-in-class therapy for PSC, addressing a significant unmet medical need.
This clinical milestone significantly strengthens CMMB's market position in the PSC therapeutic space. With no FDA-approved treatments currently available for PSC, successful development of CM-101 could capture a valuable market opportunity. The comprehensive biomarker improvements and safety profile enhance the probability of successful FDA discussions and subsequent registrational trial approval.
The planned regulatory interactions in Q4 2024 and potential registrational trial initiation in late 2025 provide clear catalysts for investor consideration. The company's market cap of
—Clinical Data from Phase 2 SPRING Trial Shows that CM-101 Demonstrated Anti-Fibrotic, Anti-Inflammatory and Anti-Cholestatic Activity across Multiple Components of Primary Sclerosing Cholangitis—
TEL AVIV, Israel, Nov. 19, 2024 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB) (Chemomab), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced that data from its Phase 2 SPRING trial in patients with primary sclerosing cholangitis (PSC) was presented at the American Association for the Study of Liver Disease (AASLD) The Liver Meeting® 2024.
In the oral, late-breaking presentation, “CM-101 improved fibrosis biomarkers in patients with primary sclerosing cholangitis: The Phase 2 SPRING Study,” Professor Christopher Bowlus, MD, FAASLD, a SPRING trial investigator and the Lena Valente Professor and Chief of the Division of Gastroenterology and Hepatology at the University of California Davis School of Medicine, discussed data from the double-blinded, placebo-controlled portion of the Phase 2 SPRING trial assessing CM-101 in patients with PSC.
The Phase 2 SPRING study tested two doses of CM-101 (10 mg/kg and 20 mg/kg) administered to PSC patients every three weeks over 15 weeks. A total of 76 patients were treated in the trial. The study analysis included assessments of all patients who completed all doses and the week 15 visit, as well as a prespecified subgroup analysis of moderate/advanced patients with a higher risk of more rapidly progressing disease.
CM-101 met the SPRING trial primary endpoint, demonstrating a favorable safety profile over the 15-week treatment period. Adverse events were generally mild/moderate and distributed similarly between the placebo and CM-101-treated dosing arms. Overall, dose-dependent responses were observed for multiple disease-related biomarker secondary endpoints. A consistent pattern of greater improvement on the secondary endpoints was observed in the study arm receiving the higher 20 mg/kg dose of CM-101 and in the subgroup of PSC patients with moderate/advanced disease. Secondary endpoint data included the following:
- Liver stiffness: Liver stiffness measured by FibroScan® improved in all CM-101 treated patients compared to placebo and significantly improved in CM-101-treated patients with moderate/advanced disease.
- ELF scores: This composite score consistently improved over the treatment period in patients with moderate/advanced fibrosis treated with 20 mg/kg of CM-101 compared to patients receiving placebo. Patients receiving the higher dose of CM-101 with moderate/advanced disease also showed statistically significant reductions at week 15 in the fibrosis-related ELF components procollagen III N-terminal peptide (PIIINP) and tissue inhibitor of metalloproteinase 1 (TIMP-1).
- PRO-C3: This serum biomarker of type III collagen synthesis was reduced in all CM-101-treated patients and showed greater reductions in patients with moderate- advanced disease.
- Liver biochemistries: A consistent pattern of decline was seen in CM-101 20 mg/kg treated-patients compared to placebo and a greater decline was seen in patients with moderate/advanced disease.
- Bilirubin: The dose-dependent improvement in total bilirubin levels seen in CM-101-treated patients provides evidence for the anti-cholestatic activity of CM-101.
- Pruritis (itch): CM-101-treated patients experienced decreased pruritus scores across all timepoints compared to placebo.
In conclusion, Dr. Bowlus noted that CM-101 was well tolerated and had a safety profile comparable to placebo, and it demonstrated dose-dependent anti-inflammatory, anti-fibrotic and anti-cholestatic effects in patients with PSC. PSC patients with moderate to advanced disease treated with CM-101 showed broad and consistent improvement in biomarkers associated with clinical outcomes. He concluded that these findings support further clinical development of CM-101 in patients with PSC.
Dr. Bowlus commented, “In the Phase 2 SPRING trial, CM-101 demonstrated that it has the potential to change the lives of patients with PSC by reducing fibrosis and cholestasis, which should lead to improved outcomes. CM-101 may also provide patients with relief of symptoms. This promising clinical data and Chemomab’s intention to advance CM-101 into a registrational trial is good news for patients with PSC, who are in desperate need of an effective, FDA approved therapy.”
Matt Frankel, MD, Chief Medical Officer of Chemomab, noted, “CM-101 is the first investigative therapy for PSC to demonstrate such broad activity across a range of biomarkers representing all major components of the disease. We welcomed the opportunity to present the promising data from the CM-101 Phase 2 SPRING study at this major scientific conference and look forward to meeting with the FDA before the end of the year to agree on a path forward to a PSC registrational trial. We expect to report on the outcome of our discussions with the FDA in the first quarter of 2025 and potentially to launch a CM-101 PSC registrational trial before the end of next year.”
An open label extension portion of the Phase 2 SPRING trial, in which all eligible patients can receive CM-101 for an additional 33 weeks, is continuing, with results expected to be reported in the first quarter of 2025.
A copy of Chemomab’s presentation at AASLD’s The Liver Meeting® 2024 is available at chemomab.com/r-d/.
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, in particular, the statements regarding our resulting cash runway. 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 Company’s ability to achieve during the first quarter of 2025 the two milestones mentioned in the press release and ensure its cash runway extends through early 2026; the likelihood that the Company can launch its PSC registrational trial in 2025, and the likelihood that the company can partner with other biopharma companies to accelerate timelines for CM-101 development in PSC and other indications; the risk that the full data set from the CM-101 study or data generated in further clinical trials of CM-101 will not be consistent with the topline results of the CM-101 Phase 2 PSC trial; failure to obtain, or delays in obtaining, regulatory approvals for CM-101 in the U.S., Europe or other territories; failure to successfully commercialize CM-101, 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 CM-101 if approved; uncertainties in the degree of market acceptance of CM-101 by physicians, patients, third-party payors and others in the healthcare community; inaccuracies in the Company's estimates of the size of the potential markets for CM-101 or in data the Company has used to identify physicians; expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates; development of unexpected safety or efficacy concerns related to CM-101; failure to successfully conduct future clinical trials for CM-101, 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 CM-101 for commercial or clinical needs, to conduct the Company's clinical trials, or to comply with the Company's agreements or laws and regulations that impact the Company's business or agreements with the Company; the strength and enforceability of the Company’s intellectual property rights or the rights of third parties; the cost and potential reputational damage resulting from litigation to which the Company may become a party, including product liability claims; 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 inability to repay the Company's existing indebtedness 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, 2023. 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. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. 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.
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 CM-101, a first-in-class dual activity monoclonal antibody that neutralizes CCL24 and has demonstrated disease-modifying potential. In clinical and preclinical studies, CM-101 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 CM-101 in patients. Based on recent promising data from its Phase 2 SPRING trial in the rare liver disease primary sclerosing cholangitis (PSC), the company expects two milestones in early 2025, including FDA feedback on the design of its planned CM-101 PSC Phase 3 registrational trial and data from the SPRING trial open label extension. CM-101 has received FDA and EMA Orphan Drug and FDA Fast Track designations for PSC. Chemomab’s CM-101 program for the treatment of systemic sclerosis is Phase 2-ready with an open U.S. IND. For more information, visit: chemomab.com.
Contacts:
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
FAQ
What were the key results of Chemomab's (CMMB) Phase 2 SPRING trial for CM-101?
How many patients participated in Chemomab's (CMMB) Phase 2 SPRING trial?
When will Chemomab (CMMB) report the results of the SPRING trial's open-label extension?
