Chemomab Announces Enrollment of First Patient in Phase 2a Study of CM-101 in Non-Alcoholic Steatohepatitis (NASH)
Chemomab Therapeutics (Nasdaq: CMMB) has started enrollment for its Phase 2a study of CM-101 aimed at treating Non-Alcoholic Steatohepatitis (NASH). CM-101, a humanized monoclonal antibody, targets CCL24 to mitigate inflammation and fibrosis. The randomized, double-blind trial will involve 40 patients and aims to evaluate CM-101's safety and anti-fibrotic effects, with results expected in the first half of 2022. This study is part of Chemomab’s broader clinical strategy, which includes ongoing trials for other fibrosis-related conditions.
- Initiation of Phase 2a study for CM-101 in NASH, addressing a critical health need.
- Potential for successful outcomes to bolster future trials for Primary Sclerosing Cholangitis and Systemic Sclerosis.
- The study's outcomes are uncertain and heavily dependent on the trial's results.
- Potential delays in data availability if enrollment or study execution faces challenges.
TEL-AVIV, Israel, April 26, 2021 /PRNewswire/ -- Chemomab Therapeutics, Ltd. (Nasdaq: CMMB), a clinical-stage biotech company focused on the discovery and development of innovative therapeutics for fibrosis-related diseases with high unmet need, today announced enrollment of the first patient in its Phase 2a study of CM-101 in Non-Alcoholic Steatohepatitis (NASH). CM-101 is a first-in-class humanized monoclonal antibody designed to bind to and block CCL24 activity, an important chemokine activity that stimulates inflammation and the development of fibrosis.
The Phase 2a study is a multi-center, randomized, double-blind, placebo-controlled, multiple dose study designed to assess the mechanism of action, safety, pharmacokinetics and pharmacodynamic effects, as well as the anti-fibrotic effects of subcutaneous CM-101 in NASH patients with fibrosis stage F2-F3. The trial will enroll 40 patients and is anticipated to complete enrollment by the end of 2021 with data expected in 1H 2022.
"We are excited to initiate this Phase 2a study of CM-101 in NASH, one of our three Phase 2 studies for CM-101," said Dr. Adi Mor, CEO of Chemomab. "Data from this study will help validate our subcutaneous delivery of CM-101 and, if successful, the subcutaneous formulation has the potential to be used in our registrational trials for Primary Sclerosing Cholangitis (PSC) and Systemic Sclerosis (SSc). Our Phase 2 PSC trial is already underway, and we are planning to initiate an additional Phase 2 trial in SSc in 2H 2021."
The study will enroll patients who have a histological confirmation of NASH without cirrhosis on a historical diagnostic liver biopsy. Patients will receive eight subcutaneous injections of CM-101 every two weeks for 14-weeks and will be assessed for serum fibrotic and fibrolysis markers, serum inflammatory markers, liver fat content, and liver stiffness.
About Chemomab Therapeutics Ltd.
Chemomab is a clinical-stage biotech company focusing on the discovery and development of innovative therapeutics for fibrosis-related diseases with high unmet need. Based on the unique and pivotal role of the soluble protein CCL24 in promoting fibrosis and inflammation, Chemomab developed CM-101, a monoclonal antibody designed to bind and block CCL24 activity. CM-101 has potential to treat multiple severe and life-threatening inflammatory and fibrotic diseases and is currently undergoing clinical development with primary focus for the orphan diseases, Primary Sclerosing Cholangitis (PSC) and Systemic Sclerosis (SSc). Chemomab is advancing in parallel three Phase 2 clinical trials with CM-101 in fibrotic indications and expecting to report data during 2022. For more information on Chemomab, please visit www.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 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: the uncertain and time-consuming regulatory approval process; risks related to Chemomab's ability to correctly manage its operating expenses and its expenses; Chemomab's plans to develop and commercialize its product candidates, focusing on CM-101; the timing of initiation of Chemomab's planned clinical trials; the timing of the availability of data from Chemomab's clinical trials; the timing of any planned investigational new drug application or new drug application; Chemomab's plans to research, develop and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of Chemomab's product candidates; Chemomab's commercialization, marketing and manufacturing capabilities and strategy; Chemomab's ability to protect its intellectual property position; and the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all. Additional risks and uncertainties relating to Chemomab's and its business can be 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.
Contact:
Investor Relations:
Irina Koffler
LifeSci Advisors, LLC
Phone: +1-917-734-7387
ir@chemomab.com
Chemomab Therapeutics:
Sharon Elkobi
VP, Business Development
Phone: +972773310156
bd@chemomab.com
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SOURCE ChemomAb Ltd.
FAQ
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