─Treatment with CM-101 Improves Additional
Biomarkers of Fibrosis and
Inflammation,
`Reinforcing and Extending Initial Study
Results─
─Provides New Insights into CM-101 Activity in
NASH Patients at Greater Risk of Progressive Disease, Providing
Further Support for CM-101's Direct Anti-inflammatory and
Anti-fibrotic Dual Mode of Action─
─Demonstrates Improvements in Key Biomarkers
Associated with Other Fibrotic Liver
Diseases
Including Primary Sclerosing Cholangitis─
TEL
AVIV, Israel, June 21,
2023 /PRNewswire/ -- Chemomab Therapeutics Ltd.
(Nasdaq: CMMB), (Chemomab), a clinical stage biotechnology company
developing innovative therapeutics for fibro-inflammatory diseases
with high unmet need, today reported topline results from secondary
analyses of its Phase 2a liver fibrosis trial assessing CM-101, its
first-in-class CCL24-neutralizing antibody, in patients with
non-alcoholic steatohepatitis (NASH). The results were included in
a late-breaking poster presentation at the 2023 EASL Congress in
Vienna,
Austria.1
Overall, the data showed improvements across an additional set
of inflammatory and fibrotic biomarkers that are consistent with
the positive clinical results Chemomab released in January.
Additionally, in NASH patients at greater risk of disease
progression, CM-101 treatment resulted in a greater biomarker
response than in NASH patients with lower risk disease or in
placebo-treated patients.
Adi Mor, PhD, Chemomab
co-founder, CEO and CSO, commented, "These additional analyses of
our liver fibrosis data in NASH patients are very encouraging. They
supplement and extend our initial data results, showing a
consistent pattern of improvement in CM-101-treated patients in
biomarkers associated with fibrogenesis and inflammation. We are
especially pleased to see that CM-101 treated-patients with higher
FAST scores—those at greater risk of progressive disease—tended to
demonstrate greater biomarker improvements than those with lower
FAST scores. Additionally, we consider these data to be highly
relevant to our ongoing CM-101 Phase 2 trial in primary sclerosing
cholangitis (PSC), demonstrating improvements in biomarkers that
are also associated with the inflammation and fibrogenesis found in
PSC patients. Notably, our PSC trial involves the evaluation of
significantly higher doses of CM-101, with patient dose cohorts of
10mg/kg and 20mg/kg administered intravenously, compared to the
liver fibrosis study in NASH patients, which used a subcutaneous
dose of 5mg/kg."
The new analyses assessed additional biomarkers and also
used the FibroScan-AST (FAST) score to categorize study patients
based on progressive disease risk, thereby enabling the evaluation
of CM-101 activity in the main target population of patients with
more active disease.2 FAST is a validated score composed
of non-invasive FibroScan® and AST measurements that is
used to identify patients with a high risk of NASH
progression.3 The results showed that:
- FAST scores were improved in a higher proportion of
CM-101-treated patients than in placebo patients.
- CM-101-treated patients with higher FAST scores demonstrated
greater improvements in key fibro-inflammatory biomarkers,
such as Pro-C3, than patients with lower FAST scores or placebo
patients.
- CM-101-treated patients with higher FAST scores showed
improvements in several fibro-inflammatory biomarkers
generally comparable to those achieved in several recent
successful NASH clinical trials.
In these secondary analyses, CM-101-treated patients showed
improvements in an additional set of biomarkers associated with
active fibrosis and inflammation:
- FIB-4, an index for determining NASH status that includes age,
platelet count, AST and ALT levels, was improved in
CM-101-treated patients vs. placebo patients.
- AST/ALT ratio, a liver enzyme ratio, was improved in
CM-101-treated patients vs. placebo patients.
- Neutrophil-to-Lymphocyte Ratio (NLR), an indicator of
inflammation, was improved in CM-101-treated patients vs. placebo
patients, and NLR was further improved in groups with higher FAST
scores.
- PRO-C3, which captures active fibrogenesis and correlates
with fibrotic disease severity, was improved in CM-101-treated
patients vs. placebo patients and was further improved in groups
with higher FAST scores. As an overall indicator of fibrogenesis
and fibrotic disease, PRO-C3 is also considered a "bridge" to PSC
and other anti-fibrotic indications.
Scott L. Friedman, MD, Dean for
Therapeutic Discovery and Chief of the Division of Liver Diseases
at the Icahn School of Medicine at Mount
Sinai in New York City, is
an expert on the fibrosis associated with chronic liver disease and
a co-author of the EASL poster. Dr. Friedman noted, "It is
encouraging that consistent positive improvements are seen across a
range of fibro-inflammatory biomarkers in both CM-101 Phase 2a
study analyses. The greater improvement in biomarkers in the higher
FAST score-enriched subgroup provides further evidence of CM-101's
potential to have a positive impact on fibrotic diseases such as
NASH and PSC, whose pathophysiology may be associated with the dual
fibro-inflammatory mechanism that CM-101 is intended to
address."
In January, the company reported that the Phase 2a liver
fibrosis trial met its primary endpoint of safety and tolerability
and that CM-101 achieved reductions in secondary endpoints that
included a range of liver fibrosis biomarkers and physiologic
assessments. The EASL poster also summarized these results,
including:
- CM-101 treatment demonstrated a favorable PK-target
engagement profile.
- CM-101 treatment was associated with improvements in multiple
fibrosis biomarkers and with a reduction in FibroScan liver
stiffness stage.
- CM-101 treatment was associated with improvements in more than
one liver fibrosis-related biomarker—almost 60% of CM-101 patients
responded in at least three biomarkers, compared to no placebo
patients.
- Higher levels at baseline of CM-101's target—the
soluble chemokine CCL24—in CM-101-treated patients were
associated with greater reductions in fibrosis-related biomarkers
and a greater likelihood of being a multiple biomarker
responder.
About the Phase 2 Liver Fibrosis Trial in NASH
Patients
The randomized, placebo-controlled trial
enrolled 23 NASH patients with stage F1c, F2 and F3 disease who
were randomized to receive either CM-101 (14 patients) or placebo
(9 patients). 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 safety
and tolerability of the SC formulation of CM-101 and to evaluate
the drug's impact on liver fibrosis biomarkers relevant to both
NASH and other rare fibro-inflammatory conditions that
are the focus for the company, such as primary sclerosing
cholangitis. For more information on the initial trial
results, click here.
- Poster presentation: Phase 2a study of CM-101, a CCL24
neutralizing antibody, in patients with nonalcoholic
steatohepatitis: A proof- of-concept study
June 21-24, 2023, 9-17:00 CEST every day: Poster-Late-Breaker,
LBP-28
- NASH patients at risk for disease progression defined as FAST
scores NAS≥4; F≥2.
- Woreta TA, Van Natta ML, Lazo M, Krishnan A, Neuschwander-Tetri
BA, Loomba R, et al. (2022) Validation of the accuracy of the FAST™
score for detecting patients with at-risk nonalcoholic
steatohepatitis (NASH) in a North American cohort and comparison to
other non-invasive algorithms. PLoS ONE 17(4): e0266859.
About Chemomab Therapeutics
Chemomab is a clinical
stage biotechnology company discovering and developing innovative
therapeutics for fibro-inflammatory diseases with high unmet need.
Based on the unique and pivotal role of the chemokine CCL24 in
promoting fibrosis and inflammation, Chemomab developed CM-101, a
monoclonal antibody designed to neutralize CCL24 activity. In
preclinical and clinical studies to date, CM-101 appears safe, with
the potential to treat multiple severe and life-threatening
fibro-inflammatory diseases. To date, Chemomab has reported
encouraging results from three clinical trials, including a Phase 2
liver fibrosis trial in NASH patients and an investigator-initiated
study in patients with severe lung injury. A Phase 2 trial in
primary sclerosing cholangitis patients is ongoing, with topline
data expected in the latter part of 2024. 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; 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 those 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 as required by law.
Contacts:
|
|
Investors:
|
Investors &
Media:
|
Irina Koffler
|
Barbara
Lindheim
|
LifeSci Advisors,
LLC
|
Chemomab
Therapeutics
|
Phone: +1 (917)
734-7387
|
Consulting Vice
President, Investor & Public Relations
|
ir@chemomab.com
|
Strategic
Communications
|
|
barbara.lindheim@chemomab.com
|
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SOURCE Chemomab Therapeutics, Ltd.