Chemomab Therapeutics Announces New Publications Reinforcing the Clinical Potential of Its CCL24-Neutralizing Antibody CM-101 in Primary Sclerosing Cholangitis
Chemomab Therapeutics announced new publications reinforcing the clinical potential of its CCL24-neutralizing antibody, CM-101, in treating primary sclerosing cholangitis (PSC). A study published in the International Journal of Molecular Science used machine learning to analyze proteomic profiles from PSC patient sera, confirming that high levels of CCL24 are linked to PSC severity and cirrhosis. This highlights the possibility of CM-101 as an effective therapy. A second study in Drug Safety reported that CM-101 showed good tolerability and reduced biomarkers of inflammation and fibrosis in Phase 1 trials. Topline data from the Phase 2 PSC trial is expected mid-2024.
- Study confirms CCL24's link to PSC severity, supporting CM-101's potential as a therapy.
- Machine learning analysis highlights the relevance of CM-101 in interrupting PSC progression.
- Phase 1 trials of CM-101 demonstrated good tolerability with rare and mild adverse events.
- Phase 1 trials showed a reduction in biomarkers of inflammation and fibrosis, suggesting therapeutic potential.
- Topline data from the Phase 2 PSC trial is expected mid-2024, providing a significant clinical proof-of-concept opportunity.
- Results are based on Phase 1 trials, which are preliminary and need further validation.
- Topline data from the Phase 2 trial is not available until mid-2024, causing a delay in conclusive evidence.
- The studies do not provide concrete clinical outcomes or definitive efficacy results.
Insights
The recent publication underscores the clinical potential of Chemomab's CCL24-neutralizing antibody, CM-101, in treating Primary Sclerosing Cholangitis (PSC), a severe liver disease. By leveraging machine learning to analyze proteomic profiles, the study provides robust evidence linking high levels of CCL24 to disease progression and severity.
,The findings are significant as they align CM-101 with essential pathways related to fibrosis and immune response, suggesting dual anti-fibrotic and anti-inflammatory effects. This dual action could be a game-changer in PSC treatment, offering a novel therapeutic avenue where no FDA-approved therapies currently exist.
,Moreover, the translational importance of the identified biomarkers can potentially enhance monitoring of disease progression in clinical settings, offering a more precise approach for patient management.
,In the short term, the anticipation of Phase 2 trial data by mid-2024 could create substantial market excitement and drive stock price volatility. Long-term implications include a potential breakthrough in PSC treatment, positioning Chemomab as a leader in fibro-inflammatory diseases.
Chemomab's recent scientific publications are likely to positively impact investor sentiment. The upcoming mid-2024 readout from the Phase 2 trial of CM-101 could serve as a critical inflection point for the company. Positive data could significantly de-risk their clinical pipeline, increasing investor confidence and potentially leading to a substantial increase in market capitalization.
,It is also noteworthy that Phase 1 studies demonstrated good tolerability for CM-101, which is often a prerequisite for successful later-stage trials. This reduces some of the clinical and regulatory risks associated with the drug development process.
,However, investors should remain cautious about the binary nature of biotech investments where the success or failure of clinical trials can drastically affect stock prices. The lack of current FDA-approved therapies for PSC indicates a high-risk, high-reward scenario.
—Proteomic Analysis of Patient Samples Further Confirms that CCL24 is Associated with Primary Sclerosing Cholangitis (PSC) Severity and Progression, Highlighting the Potential of Chemomab’s CCL24-Neutralizing Antibody CM-101 as a Promising Therapy for PSC—
—CM-101 Phase 2 PSC Trial Topline Data Readout Expected Midyear 2024—
TEL AVIV, Israel, June 18, 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 a new scientific publication that further confirms the important role of the soluble protein CCL24 in the pathologies underlying the rare fibrotic liver disease primary sclerosing cholangitis (PSC). The new study reinforces the extensive evidence showing the potential of Chemomab’s CCL24-neutralizing antibody, CM-101, to interrupt the biological processes driving PSC disease progression and severity. The study, “Machine Learning Identifies Key Proteins in Primary Sclerosing Cholangitis Progression and Links High CCL24 to Cirrhosis”1 has been published in the current online version of the peer-reviewed International Journal of Molecular Science.
The study applied machine learning to proteomic profiles of PSC patient sera to assess the involvement of CCL24 and to identify markers of disease presence, severity and cirrhosis. The pathway analysis underscored the importance of both fibrosis-related pathways and pathways associated with immune response and inflammation in PSC. Notably, the analysis showed that enrichment for PSC-related biological pathways was associated with high levels of CCL24 and that patients with cirrhosis had higher levels of CCL24, providing further evidence for the role of CCL24 in disease progression and severity. The authors also noted that the biomarkers identified in this study have significant translational importance, offering potential advancements in the monitoring of disease progression in clinical settings.
“These proteomic analyses add to the large body of data showing that CCL24 is a major driver of PSC disease progression and severity. They also confirm the importance of both fibrotic and inflammation/immune-related pathways in PSC, highlighting the relevance of the dual anti-fibrotic and anti-inflammatory activity of CM-101,” said Adi Mor, PhD, co-founder, Chief Executive Officer and Chief Scientific Officer of Chemomab. “We look forward to our CM-101 PSC Phase 2 topline data readout in the coming weeks, which has the potential to provide the first significant clinical proof-of-concept of CM-101’s therapeutic activity in this lethal disease with no FDA approved therapies.”
A second study published in the online edition of the journal Drug Safety, Targeting CCL24 in Inflammatory and Fibrotic Diseases: Rationale and Results from Three CM-101 Phase 1 Studies,2 summarized the findings of three Phase 1 studies3 of CM-101. It concluded that CM-101 successfully neutralizes CCL24, a key factor linked to inflammatory and fibrotic diseases. Phase 1a studies of intravenous (IV) and subcutaneous (SC) administration of CM-101 in healthy participants demonstrated rare and mild adverse events. In Phase 1b studies in patients with metabolic dysfunction-associated steatotic liver disease (MASLD), both IV and SC administered CM-101 exhibited good tolerability, with a notable reduction in serum levels of inflammatory, fibrotic and collagen turnover biomarkers, suggesting its therapeutic potential in addressing inflammatory and fibrotic conditions.
About Primary Sclerosing Cholangitis
PSC is a rare, progressive liver disease characterized by inflammation and fibrosis (scarring) of the bile ducts that can lead to cirrhosis of the liver, liver failure and death. PSC also increases the risk of various cancers, which account for about half of PSC-related mortality. PSC affects an estimated 30,000 patients in the U.S. and about 80,000 worldwide. The underlying cause of PSC is unknown, but about
1 Snir, T.; Greenman, R.; Aricha, R.; Frankel, M.; Lawler, J.; Saffioti, F.; Pinzani, M.; Thorburn, D.; Mor, A.; Vaknin, I. Machine Learning Identifies Key Proteins in Primary Sclerosing Cholangitis Progression and Links High CCL24 to Cirrhosis. Int. J. Mol. Sci. 2024, 25, 6042. https://doi.org/10.3390/ijms25116042
2 Mor, A., Friedman, S., Hashmueli, S. et al. Targeting CCL24 in Inflammatory and Fibrotic Diseases: Rationale and Results from Three CM-101 Phase 1 Studies. Drug Saf (2024). https://doi.org/10.1007/s40264-024-01436-2
3 Clinical trial retrospective registration NCT06025851, NCT06037577, and NCT06044467. Date of registration: September 2023
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. These forward-looking statements include, among other things, the clinical development pathway for CM-101; the expectation that Chemomab will report topline data from the PSC clinical trial by mid-year 2024; the length, duration and impact of the war in Israel on Chemomab’s business and operations; the future operations of Chemomab and its ability to successfully initiate and complete clinical trials and achieve regulatory milestones; the nature, strategy and focus of Chemomab; the development and commercial potential and potential benefits of any product candidates of Chemomab; and that the product candidates have the potential to address high unmet needs of patients with serious fibrosis-related diseases and conditions. Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements are based upon Chemomab's current expectations. Forward-looking statements involve risks and uncertainties. Because such statements deal with future events and are based on Chemomab's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Chemomab could differ materially from those described in or implied by the statements in this presentation, including those found under the caption "Risk Factors" and elsewhere in Chemomab's filings and reports with the SEC. Chemomab expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Chemomab's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based, except as required by law.
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 and pivotal role of CCL24 in promoting fibrosis and inflammation, Chemomab developed CM-101, a monoclonal antibody that neutralizes CCL24 activity. In clinical and preclinical studies, CM-101 appears safe, with the potential to treat multiple severe and life-threatening fibro-inflammatory diseases. Chemomab has reported positive results from three clinical trials of CM-101 in patients, including a Phase 2a liver fibrosis trial in NASH patients and an investigator-initiated study in patients with severe lung injury. A Phase 2 trial in primary sclerosing cholangitis has completed patient enrollment, with topline data expected midyear 2024. Chemomab’s CM-101 program for the treatment of systemic sclerosis is Phase 2-ready with an open U.S. IND. For more information about Chemomab, visit chemomab.com.
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Barbara Lindheim
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Phone: +1 917-355-9234
barbara.lindheim@chemomab.com
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