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.