Chemomab Therapeutics, Ltd., (Nasdaq: CMMB), a clinical stage
biotechnology company developing innovative therapeutics for
fibro-inflammatory diseases with high unmet need, today announced
that data from the company’s Phase 2 SPRING trial of nebokitug
(CM-101) in primary sclerosing cholangitis (PSC)1 was presented in
an oral Distinguished Abstract Plenary session at Digestive Disease
Week® (DDW 2025) in San Diego, California.
Paul J. Pockros, MD, Director, Liver Disease Center Scripps
Clinic and Director of SC Liver Research Consortium, who was a
SPRING trial investigator, presented the nebokitug data. He noted,
“PSC is a potentially devastating progressive disease that lacks
any FDA-approved therapies. The data from the SPRING trial are very
encouraging, showing that nebokitug appears safe and well-tolerated
over 48 weeks of treatment. Notably, patients with more active
moderate to severe disease showed sustained improvements in
multiple biomarkers associated with disease progression. We believe
these findings suggest that nebokitug may have disease-modifying
potential and support developing nebokitug 20 mg/kg in a Phase 3
clinical study in patients with PSC.”
The DDW 2025 session presented data from the double-blind,
placebo-controlled 15-week treatment period showing that nebokitug
was well-tolerated and had a safety profile comparable to placebo.
Nebokitug demonstrated dose dependent anti-inflammatory,
anti-fibrotic and anti-cholestatic effects in patients with PSC. In
a prespecified subgroup of patients with moderate to advanced
disease, patients treated with nebokitug showed broad and
consistent improvement in biomarkers that have been associated with
better clinical outcomes.
The presentation also included data from the open label
extension portion of the study, in which all eligible study
patients received nebokitug for up to an additional 33 weeks. This
data showed that nebokitug was safe and well-tolerated for up to 48
weeks of treatment. Patients treated with nebokitug showed
sustained or continual improvement in markers of fibrosis and
sustained and continual reduction in ELF scores, especially in
patients with moderate to advanced disease receiving the 20 mg/kg
dose. Patients also experienced stabilization of liver stiffness as
measured by transient elastography, especially in those with
moderate to advanced disease receiving the 20 mg/kg dose.
Adi Mor, PhD, co-founder and Chief Executive Officer of
Chemomab, commented, “We believe the nebokitug SPRING trial data
are the strongest to date in this debilitating and potentially
lethal disease that lacks effective treatment. We are pleased that
these positive data were featured at a major multi-disciplinary
medical meeting like DDW 2025, as we continue to assess the best
options for advancing nebokitug to a Phase 3 trial.”
A copy of the DDW 2025 presentation is now available at the
R&D pages of the Chemomab website.
1 CM-101, a novel monoclonal antibody targeting CCL24, was safe,
well-tolerated and showed improvements of biomarkers associated
with inflammation, fibrosis and cholestasis in patients wit primary
sclerosing cholangitis: the SPRING study, CL Bowlus, ST Barclay, D
Joshi, MC Londoño, P Mantry, PJ Pockros, R Safadi, R Aricha, C
Cirillo, M Frankel, J Lawler, I Vaknin, A Mor, D Thorburn on behalf
of the SPRING Study Investigators, DDW 2025, Liver & Biliary
Section Distinguished Abstract Plenary, May 4, 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
forward-looking statements. You should not rely upon
forward-looking statements as predictions of future events. Except
as required by law, we undertake no obligation to update publicly
any forward-looking statements for any reason after the date of
this press release. Before you invest, you should read the
documents we have filed and will file with the SEC for more
complete information about us. You may get these documents for free
by visiting EDGAR on the SEC website at www.sec.gov. This press
release shall not constitute an offer to sell or the solicitation
of an offer to buy these securities, nor shall there be any sale of
these securities in any state or jurisdiction in which such offer,
solicitation, or sale would be unlawful prior to registration or
qualification under the securities law of any such state or
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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