—Clean Safety Review Supports Addition of Higher Dose
Cohort into the Trial—
TEL
AVIV, Israel, Dec. 21,
2022 /PRNewswire/ -- Chemomab Therapeutics, Ltd.
(Nasdaq: CMMB) (Chemomab), a clinical-stage biotech company focused
on the discovery and development of innovative therapeutics for
fibrotic and inflammatory diseases with high unmet need, today
announced that an independent Data Monitoring Committee (DMC) has
completed a safety review of the company's ongoing Phase 2 trial of
lead product CM-101 in primary sclerosing cholangitis (PSC)
patients. The DMC had no safety concerns with proceeding with
adding a planned 20 milligram per kilogram (mg/kg) dosing cohort to
the PSC trial, as defined in a recent protocol amendment. The PSC
trial currently has a single 10mg/kg dose, administered every three
weeks by intravenous (IV) infusion.

The DMC review was based on both blinded safety data from the
PSC trial and from Chemomab's Phase 2a liver fibrosis biomarker
trial in patients with non-alcoholic steatohepatitis (NASH).
Chemomab plans to report top-line results from this latter trial in
the coming weeks.
"Our first-in-class CCL24-neutralizing antibody, CM-101, had
demonstrated a clean safety profile in Phase 1 trials, and we are
pleased the DMC review of current Phase 2 patient data has
confirmed these findings," said Matthew
Frankel, MD, Chief Medical Officer of Chemomab. "We view PSC
as a promising clinical indication for CM-101 based on the
extensive preclinical and translational data generated by our
researchers, which highlights both the potential role of the
soluble target CCL-24 in PSC-related disease pathophysiology and
evidence of CM-101's potential to attenuate these
fibro-inflammatory processes."
The CM-101 Phase 2 SPRING trial is a randomized,
placebo-controlled, multiple dose study enrolling PSC patients with
large duct disease. In the trial's double blind treatment period,
all enrolled patients receive five IV administrations of either
CM-101 or placebo every three weeks over a 15-week treatment
period. The trial also includes an open label extension, with
administration of up to 11 additional doses of CM-101 given every
three weeks. The addition of the open label extension brings the
maximal duration of treatment to 48 weeks. The primary outcome of
the trial is safety and tolerability, with secondary outcomes
including a wide range of relevant biomarkers and physiological
assessments. Top-line data from the Phase 2 PSC trial is expected
in the second half of 2024.
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. It is
currently in Phase 2 trials for primary sclerosing cholangitis and
liver fibrosis, with a Phase 2 trial in systemic sclerosis expected
to begin enrolling patients in early 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; 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:
|
|
Media:
|
Investor
Relations:
|
Barbara
Lindheim
|
Irina
Koffler
|
Chemomab
Therapeutics
|
LifeSci Advisors,
LLC
|
Consulting Vice
President
|
Phone:
+1-917-734-7387
|
Investor & Public
Relations,
|
ir@chemomab.com
|
Strategic
Communications
|
|
Phone:
+1-917-355-9234
|
|
barbara@chemomab.com
|
|
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SOURCE Chemomab Therapeutics, Ltd.