Chemomab Therapeutics, Ltd., (Nasdaq: CMMB), a clinical stage
biotechnology company developing innovative therapeutics for
fibro-inflammatory diseases with high unmet need, today reported
data from two study abstracts that will be presented as posters at
EASL 2025, the Annual Congress of the European Association for the
Study of the Liver, that will be held May 7–10, 2025, in Amsterdam,
the Netherlands.
Adi Mor, PhD, co-founder and Chief Executive Officer of
Chemomab, commented, “This new clinical data further confirms the
potential of nebokitug (CM-101) as a first-in-class treatment for
primary sclerosing cholangitis (PSC) and other fibro-inflammatory
diseases. The comprehensive proteomic analyses we are presenting at
EASL 2025 indicate that treatment with nebokitug resulted in
additional improvements in a wide variety of biomarkers that are
broadly related to fibro-inflammatory disease pathways including in
PSC, inflammatory bowel disease, and inflammation and fibrosis in
general.”
Comprehensive proteomic analyses of 3,000 circulating proteins
in patient samples from the Phase 2 SPRING trial in patients with
PSC showed that nebokitug-treated patients exhibited significant
and dose-dependent changes in multiple proteins, including those
playing a key role in fibrosis, immune cell recruitment and
inflammation.1 The analysis provided new insights into PSC
disease-related pathways and additional biological evidence of the
clinical activity of nebokitug. Nebokitug-treated patients showed
downregulation of biological processes related to fibrosis and
inflammation, such as cell-cell adhesion and extracellular matrix
organization, as well as to molecular functions including binding
of growth factors and integrins.
Treatment with nebokitug was also linked to the downregulation
of disease-related proteins and pathways involved with leukocyte
migration, cytokine activity, chemokine activity and collagen
binding. The authors highlight how nebokitug’s ability to
neutralize its CCL24 target exerts a wide impact, as demonstrated
by the reductions in a broad array of inflammatory and fibrotic
biomarkers in treated patients.
The second abstract presents an analysis of the pharmacodynamics
and pharmacokinetics (PK) of nebokitug and CCL24 using patient data
from the Phase 2 SPRING trial in patients with PSC.2 PK analyses
indicated dose-proportional increases in the concentration of
nebokitug with steady-state levels achieved after the fourth dose.
These increased levels of nebokitug corresponded with increased
levels of nebokitug’s CCL24 target, reflecting effective
antibody-target engagement that was dose-dependent between the two
treatment groups. Importantly, linear regression analyses found
trends between increasing patient exposure to nebokitug and
decreasing levels of relevant PSC disease biomarkers, including
liver enzyme and transient elastography scores.
Copies of the EASL 2025 posters will be available at the R&D
pages of the Chemomab website starting on the date they are
presented.
1 CCL24 blockade alters the proteomic profile of patients with
primary sclerosing cholangitis and down-regulates central disease
processes, T Snir, R Greenman, R Aricha, I Vaknin, M Frankel, J
Lawler, A Mor, EASL 2025 Abstract #1243, May 9, 2025
2 CM-101 impacts disease biomarkers in primary sclerosing
cholangitis: assessment of the SPRING study pharmacokinetics and
pharmacodynamics, M Frankel, J Lawler, I Vaknin, A Mor, EASL 2025
Abstract #1255, May 8, 2025
Forward-Looking StatementsThis 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. 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 risk that certain acknowledgements from the
End-of-Phase 2 (EOP2) meeting with the FDA in connection with PSC
regulatory approval will not materialize into a pathway for
regulatory approval; that certain conclusions and assumptions drawn
from the EOP2 meeting with the FDA discussed in the press release
will prove incorrect and adversely affect the ability for nebokitug
to become an FDA fully approved therapy; the risk that the full
data set from the nebokitug study or data generated in further
clinical trials of nebokitug will not be consistent with the
topline results of the nebokitug Phase 2 PSC trial; failure to
obtain, or delays in obtaining, regulatory approvals for nebokitug
in the U.S., Europe or other territories; failure to successfully
commercialize nebokitug, 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
nebokitug if approved; uncertainties in the degree of market
acceptance of nebokitug by physicians, patients, third-party payors
and others in the healthcare community; nebokitug development of
unexpected safety or efficacy concerns related to nebokitug;
failure to successfully conduct future clinical trials for
nebokitug, 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 nebokitug for
commercial or clinical needs, to conduct the Company's clinical
trials; 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
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, 2024. 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
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of an offer to buy these securities, nor shall there be any sale of
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jurisdiction.
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 nebokitug (CM-101), a
first-in-class dual activity monoclonal antibody that neutralizes
CCL24 and has demonstrated disease-modifying potential. In clinical
and preclinical studies, nebokitug 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 nebokitug in patients. Based on
positive data from its Phase 2 SPRING trial in primary sclerosing
cholangitis (PSC), the company is preparing for potential
initiation of a nebokitug PSC Phase 3 trial. The design of Phase 3
calls for a single pivotal trial based on a clinical event primary
endpoint that provides a clear and streamlined pathway to potential
full regulatory approval. Nebokitug has received FDA and EMA Orphan
Drug and FDA Fast Track designations for the treatment of PSC.
Chemomab’s nebokitug program for the treatment of systemic
sclerosis has an open U.S. IND. For more information, visit:
chemomab.com. Contact:
Media and Investors:Barbara LindheimConsulting
Vice President, Investor & Public Relations, Strategic
CommunicationsPhone: +1
917-355-9234barbara.lindheim@chemomab.comIR@chemomab.com
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