Chemomab Therapeutics to Present Its CM-101 Clinical Program in Primary Sclerosing Cholangitis at 2023 Roth MKM Healthcare Opportunities Conference
- CM-101 shows dual anti-fibrotic and anti-inflammatory activity
- Positive results from Phase 2a trial in NASH patients
- Potential as a disease-modifying therapy for PSC
- None.
--CM-101's Unique Dual Anti-Fibrotic and Anti-Inflammatory Activity Supports Its Disease Modifying Potential in Primary Sclerosing Cholangitis (PSC)---
--CM-101 Phase 2 SPRING Trial in PSC is Advancing Towards Completion of Enrollment with Topline Readout Currently Targeted in Second Half of 2024--
Chemomab's first-in-class monoclonal antibody CM-101 neutralizes CCL24, a novel target that has been shown to play a central role in the processes that drive fibrosis and inflammation. CM-101 is currently being assessed in the Phase 2 SPRING trial for the treatment of PSC, with topline data expected in the second half of 2024.
PSC is a potentially lethal condition that lacks any FDA-approved therapies and frequently requires liver transplant. Unlike the other drugs in clinical development for PSC, CM-101 has a unique dual mechanism of action that simultaneously blocks fibrosis and inflammation. In extensive preclinical and early clinical studies, this distinctive, multifaceted approach has been shown to inhibit fibrogenesis and interfere with the core pathways that result in the liver damage associated with PSC.
Earlier this year, Chemomab reported positive results from a Phase 2a liver fibrosis trial in patients with nonalcoholic steatohepatitis (NASH). A majority of patients treated with CM-101 demonstrated improvements in multiple biomarkers associated with fibrosis and inflammation. A higher percentage of patients responding to treatment with CM-101 had improvements in Enhanced Liver Fibrosis (ELF) scores, liver stiffness as measured by transient elastography, and PRO-C3 levels compared to placebo.
The ELF score, liver stiffness as measured by transient elastography and PRO-C3, a marker of collagen III formation, have all been identified as prognostic markers and independent predictors of transplant-free survival and improved patient outcomes in PSC. These results suggest that CM-101 possesses anti-fibrotic properties in the liver that may also be relevant in PSC, and Chemomab views these data as promising for a potentially successful translation to the treatment of PSC.
The company's ongoing PSC Phase 2 SPRING trial is evaluating two dose cohorts that are intended to provide high exposure to CM-101 (10 and 20mg/kg intravenously administered, compared to 5mg/kg via subcutaneous injection in the liver fibrosis/NASH trial), as well as an open-label extension providing for longer-term evaluation of the effects of CM-101 treatment for up to 48 weeks, thereby enhancing the opportunity for a more comprehensive assessment of CM-101's therapeutic potential in PSC.
"We have reported a number of positive CM-101 developments this year," said Dr. Mor. "First, we reported consistent, positive biomarker data from our Phase 2 liver fibrosis trial in NASH patients that we believe are directly relevant to PSC; second, we presented several supportive preclinical PSC studies at major scientific meetings and published a peer-reviewed scientific review of the role of CCL24 in PSC; and third, the strong commitment of PSC patients and clinicians to the Phase 2 SPRING trial is enabling us to advance enrollment at a robust pace."
Dr. Mor added, "We consider the recent announcement of promising results in Pliant's Phase 2 PSC study as a positive for the field, highlighting the unmet need in PSC and the possible utility of anti-fibrotic agents in this condition. Our continued clinical progress in validating CM-101's unique dual anti-inflammatory and anti-fibrotic activity reinforces our optimism that CM-101 may have potential as a disease-modifying therapy for PSC. We look forward to discussing the CM-101 PSC program at the upcoming Roth MKM conference as we advance towards completing our Phase 2 trial and reporting topline results in the coming year."
Attendance at the conference is by invitation only. To register for the 2023 Roth-MKM Healthcare Opportunities Conference, click here, or contact a Roth MKM sales representative.
About CM-101
CM-101 is a monoclonal antibody that neutralizes CCL24, a soluble protein that helps drive the inflammatory and fibrotic pathways central to many fibro-inflammatory diseases. CCL24's role as a therapeutic target has been validated in extensive preclinical studies and Chemomab researchers have demonstrated preclinical proof-of-concept for CM-101 in multiple animal and patient sample studies. CM-101 was safe and well tolerated in Phase 1 and Phase 2 clinical trials to date. In a Phase 1b study it improved liver biomarkers, decreased liver stiffness and demonstrated a favorable PK and target engagement profile in patients with nonalcoholic fatty liver disease (NAFLD). Data from a completed Phase 2a liver fibrosis trial in NASH patients (NCT05824156) reported earlier this year showed consistent, positive improvements in key inflammatory and fibrogenesis-related biomarkers, including several that may serve as a potential bridge to activity in PSC. CM-101 is currently being evaluated in PSC patients in the Phase 2 SPRING trial (NCT04595825), with a topline readout expected in the second half of 2024.
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 designed to neutralize CCL24 activity. In preclinical and clinical studies, CM-101 appears safe, with the potential to treat multiple severe and life-threatening fibro-inflammatory diseases. Chemomab has reported encouraging results from three clinical trials of CM-101 in patients, including a Phase 1b trial in NAFLD patients, a Phase 2 liver fibrosis trial in NASH patients and an investigator-initiated study in patients with severe lung injury. The CM-101 program for the treatment of systemic sclerosis is Phase 2-ready and a Phase 2 trial in primary sclerosing cholangitis patients is ongoing, with topline data expected in the second half of 2024. For more information about Chemomab, visit chemomab.com.
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, statements regarding the clinical development pathway for CM-101; the future operations of Chemomab and its ability to successfully initiate and complete clinical trials and achieve regulatory milestones; the Company's cash position and expectations regarding its ability to achieve the topline data readout from the Phase 2 primary sclerosing cholangitis (PSC) trial of CM-101 with its current cash; 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.
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
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SOURCE Chemomab Therapeutics, Ltd.
