—Expected Topline Data Readout Accelerated to
Midyear 2024 Following Early Completion of Patient Enrollment in
Phase 2 Primary Sclerosing Cholangitis (PSC) SPRING Trial—
—CM-101's Unique Dual Anti-Fibrotic and
Anti-Inflammatory Activity Has Disease Modifying Potential
in PSC, Which Often Results in Liver Transplant or Death and
Lacks Any FDA-Approved Treatments—
TEL
AVIV, Israel, Jan. 3, 2024
/PRNewswire/ -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB)
(Chemomab), a clinical stage biotechnology company focused on the
discovery and development of innovative therapeutics for
fibro-inflammatory diseases with high unmet need, today
announced early completion of patient enrollment in its Phase
2 clinical trial assessing CM-101 as a treatment for primary
sclerosing cholangitis (PSC). The company also announced that it
expects to report topline data from the PSC clinical trial by
midyear 2024, rather than in the second half of 2024 as previously
projected.
"We are delighted we were able to accelerate our expected
topline PSC clinical data milestone to midyear 2024 as a result of
early completion of patient enrollment in this critical Phase 2
trial," said Adi Mor, PhD,
co-founder, Chief Executive Officer and Chief Scientific Officer of
Chemomab. "We believe that CM-101 has the potential for
disease-modifying activity in PSC, a severe fibro-inflammatory
liver disease that has no FDA-approved therapies. We anticipate
that positive data from this 68-patient clinical trial would be a
major catalyst for Chemomab and allow us to move towards a
registrational trial in PSC. Positive data would also set the stage
for advancing CM-101 in other fibro-inflammatory diseases such as
systemic sclerosis, where we have an open U.S. IND to conduct a
Phase 2 clinical trial."
CM-101 is a first-in-class monoclonal antibody that neutralizes
the soluble protein CCL24, which in preclinical and clinical
studies has been associated with key pathways underlying PSC
pathophysiology. CM-101's dual anti-inflammatory and anti-fibrotic
activity has demonstrated disease modifying potential in PSC and
other fibro-inflammatory disorders. CM-101 has Orphan Drug
designation for PSC in the U.S. and the European Union (EU) and was
recently awarded Fast Track designation by the U.S. Food & Drug
Administration (FDA).
Chemomab Chief Medical Officer Matt
Frankel, MD, added, "We appreciate the diligent work of our
clinical and medical teams and our collaborators at medical centers
around the world who completed enrollment in the PSC trial ahead of
projections, as well as the commitment of the many patients and
advocacy organizations who contributed to the success of the study
to date. We are gratified at the high level of interest the SPRING
trial has generated among patients and physicians, highlighting the
urgent need for effective PSC therapies."
Chemomab's Phase 2 SPRING trial (NCT04595825) is a
double-blind, placebo-controlled, multiple dose study assessing the
safety and tolerability of CM-101 administered to PSC patients with
established large duct disease. The trial has completed enrollment
of the planned 68 patients in the U.S., EU and Israel. Enrolled patients receive either 10
mg/kg or 20 mg/kg of CM-101 or placebo via an intravenous infusion
every three weeks over 15 weeks. The SPRING trial includes an open
label extension available to all study participants, who receive
infusions of either 10 mg/kg or 20 mg/kg of CM-101 every three
weeks for an additional 33 weeks. In addition to safety, the
trial is measuring a wide range of secondary outcomes including
serum biomarkers and physiological parameters. These include
well-validated liver biomarkers such as alkaline phosphatase (ALP),
ELF and PRO-C3, as well as FibroScan assessments of liver
stiffness.
About CM-101
CM-101 is a monoclonal antibody that
neutralizes CCL24, a soluble protein that helps drive the
inflammatory and fibrotic pathways central to many
fibro-inflammatory diseases. CCL24's role as a therapeutic target
has been validated in extensive preclinical studies and Chemomab
researchers have demonstrated preclinical proof-of-concept for
CM-101 in multiple animal and patient sample studies. CM-101 was
safe and well tolerated in Phase 1 and Phase 2 clinical trials to
date. In a Phase 1b study it improved liver biomarkers,
decreased liver stiffness and demonstrated a favorable PK and
target engagement profile in patients with nonalcoholic fatty liver
disease (NAFLD). Data from a completed Phase 2a liver fibrosis
trial in nonalcoholic steatohepatitis (NASH) patients (NCT05824156)
reported in 2023 showed consistent, positive improvements in key
inflammatory and fibrogenesis-related biomarkers, including several
that may serve as a potential bridge to activity in PSC. CM-101 has
received Orphan Drug designation from the FDA and the EU's EMA,
along with FDA Fast Track status.
About Primary Sclerosing Cholangitis
PSC is a rare,
progressive liver disease, characterized by inflammation and
fibrosis (scarring) of the bile ducts. Eventually, it can lead to
cirrhosis of the liver and liver failure. PSC also increases the
risk of various cancers, which account for about half of PSC
deaths. PSC affects an estimated 30,000 patients in the U.S. and
about 80,000 worldwide. The disease can occur in all ages, genders
and races, but is more common in men and is typically diagnosed in
patients in their 40s. The underlying cause of PSC is unknown, but
about 75% of individuals with PSC also have inflammatory bowel
disease. Currently there are no FDA or EMA-approved therapies for
patients with PSC. Liver transplantation is common in advanced
cases, but even then, PSC re-occurs in about 20% of transplanted
patients. There is a high unmet need for therapeutic options to
address the symptoms and modify the progression of this devastating
illness.
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 expectation that Chemomab will
report topline data from the PSC clinical trial by mid-year 2024;
the length, duration and impact of the war in Israel on Chemomab's business and operations;
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.
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 and pivotal role of CCL24 in promoting fibrosis
and inflammation, Chemomab developed CM-101, a monoclonal antibody
that neutralizes CCL24 activity. In preclinical and clinical
studies, CM-101 appears safe, with the potential to treat multiple
severe and life-threatening fibro-inflammatory diseases. Chemomab
has reported encouraging results from three clinical trials of
CM-101 in patients, including a Phase 1b trial in NAFLD patients, a Phase 2a liver
fibrosis trial in NASH patients and an investigator-initiated study
in patients with severe lung injury. The CM-101 program for the
treatment of systemic sclerosis is Phase 2-ready with an open U.S.
IND. A Phase 2 trial in primary sclerosing cholangitis patients has
completed patient enrollment, with topline data expected in midyear
2024. For more information about Chemomab, visit chemomab.com.
Contacts:
Media and Investors:
Barbara Lindheim
Consulting Vice President, Investor & Public Relations,
Strategic Communications
Phone: +1 917-355-9234
barbara.lindheim@chemomab.com
IR@chemomab.com
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SOURCE Chemomab Therapeutics, Ltd.