—CM-101 Met Primary Endpoint of Safety and
Tolerability and Showed Positive Activity Across Multiple Liver
Fibrosis Biomarkers and Physiologic Assessments—
TEL AVIV,
Israel, Jan. 3, 2023 /PRNewswire/ -- Chemomab
Therapeutics, Ltd. (Nasdaq: CMMB) (Chemomab), a clinical-stage
biotechnology company focused on the discovery and development of
innovative therapeutics for fibrotic and inflammatory diseases with
high unmet need, today reported top-line results from its Phase 2a
trial assessing CM-101, its first-in-class CCL24-neutralizing
monoclonal antibody, in non-alcoholic steatohepatitis (NASH)
patients. The trial met its primary endpoint of safety and
tolerability, and CM-101 achieved reductions in secondary endpoints
that include a range of liver fibrosis biomarkers and physiologic
assessments measured at baseline and at week 20.

The randomized, placebo-controlled trial enrolled
23 NASH patients with stage F1c, F2 and F3 disease who were
randomized to receive either CM-101 or placebo. Patients received
eight doses of 5 mg/kg of CM-101 or placebo, administered by
subcutaneous (SC) injection once every two weeks, for a treatment
period of 16 weeks. This trial was primarily designed to
assess the subcutaneous formulation of CM-101 and to evaluate the
drug's impact on liver fibrosis biomarkers relevant to both NASH
and the rare fibro-inflammatory conditions that represent the focus
for the company, such as primary sclerosing cholangitis (PSC) and
systemic sclerosis (SSc).
Dale Pfost, PhD,
Chief Executive Officer of Chemomab, said, "It is noteworthy that
this trial confirmed the safety and tolerability of CM-101 and the
pharmacokinetics of our subcutaneous formulation, while providing
biomarker data further demonstrating the anti-inflammatory and
anti-fibrotic activity of CM-101. We are especially pleased with
these encouraging findings given the small size of the study, the
short duration of treatment and the relatively low dose of CM-101
that was administered."
Dr. Pfost continued, "This is the third clinical
trial in patients demonstrating the activity of CM-101 as measured
by fibro-inflammatory biomarkers and physiological assessments. It
confirms similar data we reported in our Phase 1b study in patients with non-alcoholic fatty
liver disease (NAFLD) and in our recently reported investigator
study of acute lung injury in COVID patients. Collectively, these
data encompassing diverse organs and conditions reinforce our
optimism about our ongoing Phase 2 trial in primary sclerosing
cholangitis and our Phase 2 trial in systemic sclerosis that is
scheduled to begin early this year."
Key findings of the CM-101 Phase 2a trial
included the following.
- CM-101 continues to appear safe and was well tolerated when
administered subcutaneously. Most reported adverse events
observed were mild, with one unrelated serious adverse event
reported. No significant injection site reactions were observed and
no anti-drug antibodies were detected.
- CM-101 administered subcutaneously demonstrated favorable
pharmacokinetics and target engagement profiles as expected;
they were similar to what the company has previously reported.
- CM-101-treated patients showed greater improvements than the
placebo group in a number of liver fibrosis-related biomarkers,
including ProC-3, ProC-4, ProC-18, TIMP-1 and ELF.
- A majority of CM-101-treated patients showed improvements in
more than one liver fibrosis-related biomarker—almost 60% of
CM-101-treated patients responded in at least three
biomarkers at week 20, compared to no patients in the
placebo group.
- CM-101-treated patients with higher CCL24 levels at baseline
showed greater reductions in fibrosis-related biomarkers than
patients with lower CCL24 levels. Patients with higher CCL24 at
baseline were also more likely to be responders in multiple
fibrosis-related biomarkers than patients with lower CCL24 levels,
adding to the growing body of evidence validating the role of CCL24
in the pathophysiology of fibrotic liver disease.
- A higher proportion of patients in the CM-101-treated group
showed improvement in a physiologic measure of liver
stiffness as compared to placebo (reduction of at least
one grade of fibrosis score as assessed by the non-invasive
elastography method known as FibroScan®).
- After completion of the study, the unblinded data showed that
patients in the CM-101-treated group had higher baseline levels of
fibrosis compared to placebo-treated patients. The impact of this
difference on the results, if any, is unknown.
Massimo Pinzani,
MD, PhD, Professor of Medicine, Director of the University
College London (UCL) Institute for Liver and Digestive Health and
the Sheila Sherlock Chair of Hepatology at UCL, commented, "These
encouraging Phase 2a results for CM-101 are a good example of what
one is seeking in a successful biomarker study–sets of multiple
biomarkers moving together in a positive direction. Based on these
early findings, CM-101 may have the potential to interrupt the
inflammatory and fibrotic vicious cycle characterizing conditions
such as PSC, systemic sclerosis and other fibro-inflammatory
diseases, providing the potential for much-needed disease-modifying
therapy."
Rifaat Safadi, MD,
Professor in Medicine, Gastroenterology and Hepatology, Faculty of
Medicine, Hadassah University Hospital, Jerusalem; a Visiting Scholar at the Division
of Liver Diseases, Mount Sinai School of Medicine in New York City, and Principal Investigator of
the Phase 2a study noted, "The results from this early trial
confirm previous clinical and preclinical research suggesting that
neutralizing the pro-fibrotic and pro-inflammatory effects of CCL24
may have a therapeutic benefit for patients battling intractable
fibro-inflammatory diseases such as PSC and systemic sclerosis, and
support the conduct of additional clinical trials to address this
unmet medical need. I want to thank the patients who participated
in this trial and the team members at the clinical sites who helped
make these encouraging results possible."
For more information on Chemomab's Phase 2 SPRING
trial In patients with primary sclerosing cholangitis, visit
www.chemomab.com/trials/psc/, or click here for information for
potential participants.
About Chemomab
Therapeutics
Chemomab is a clinical stage biotechnology company focusing on
the discovery and development of innovative therapeutics for
fibrotic and inflammatory 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 demonstrated the potential to treat multiple severe and
life-threatening fibrotic and inflammatory diseases. A Phase 2
liver fibrosis biomarker study in NASH patients was recently
completed and a Phase 2 trial in primary sclerosing cholangitis
patients is ongoing. Chemomab expects to begin enrolling patients
in a Phase 2 trial in systemic sclerosis early in 2023. For more
information on 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 and the results of the Phase 2a Liver Fibrosis Biomarker
trial in NASH patients on future development plans; 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: risks related to Chemomab's ability to effectively
implement the revised clinical strategy and its ability to achieve
the anticipated results; risks related to the projections and
associated benefits in pursuing the contemplated changes to the
clinical strategy; risks associated with the ongoing transitions of
certain of our executive officers, including Chemomab's new Chief
Executive Officer; 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 including any potential delays associated with
Chemomab's contemplated revised clinical strategy; 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,
except to the extent required by applicable law.
Contacts:
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Media:
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Investor
Relations:
|
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Barbara
Lindheim
|
Irina
Koffler
|
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Chemomab
Therapeutics
|
LifeSci Advisors,
LLC
|
|
Consulting Vice
President
|
Phone:
+1-917-734-7387
|
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Investor & Public
Relations,
|
ir@chemomab.com
|
|
Strategic
Communications
|
|
|
Phone:
+1-917-355-9234
|
|
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barbara@chemomab.com
|
|
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