—CM-101's Unique Dual Anti-Fibrotic and
Anti-Inflammatory Activity Has Disease Modifying Potential in this
Poorly Treated Condition—
—CM-101's Phase 2 SPRING Trial in PSC is
Advancing Towards Completion of Enrollment with Top-line Readout
Expected in 2H 2024—
TEL
AVIV, Israel, Nov. 15,
2023 /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 that the U.S. Food and Drug Administration (FDA) has
granted CM-101 Fast Track designation for the treatment in adult
patients of primary sclerosing cholangitis (PSC), a fibrotic liver
disease that can result in liver transplant, cancer and early
death.
Fast Track is a process developed by the FDA to facilitate and
expedite the development of new treatments that demonstrate a
potential to address unmet medical needs in serious or
life-threatening conditions. Programs with Fast Track designation
can benefit from early and more frequent interactions with the FDA
during the clinical development process. Therapeutic candidates
with Fast Track designation may also be eligible for priority
review and accelerated approval if supported by clinical data.
"This FDA Fast Track designation is an important validation of
CM-101's potential to have a major impact on this devastating
disease that attacks people in their prime years and lacks any
approved treatments," said Adi Mor,
PhD, co-founder, Chief Executive Officer and Chief Scientific
Officer of Chemomab. "We designed the CM-101 Phase 2 SPRING trial
to be supportive of a registrational trial in patients with PSC,
and we welcome the enhanced opportunities for working closely with
the FDA and for acceleration of the development and review process
provided by Fast Track status."
There are no FDA-approved treatments for PSC. 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, which
is designed to break the vicious cycle driving these pathways, has
demonstrated the potential for disease modifying activity in
preclinical and early clinical studies of PSC-related
processes.
Chemomab Chief Medical Officer Matt
Frankel, MD, added, "Promising biomarker and elastography
results from our Phase 2a liver fibrosis study in nonalcoholic
steatohepatitis (NASH) patients reported earlier this year
reinforced our optimism about the therapeutic potential of CM-101.
There are common fibrosis pathways in NASH and PSC, and CM-101's
relevance to PSC is supported by extensive preclinical and patient
sample studies. We also are encouraged by robust patient enrollment
in the SPRING trial, which speaks to the high unmet need
experienced by these patients. We look forward to continuing our
work with PSC patients, their clinicians and the FDA to expedite
advancement of CM-101 as a potential treatment for this terrible
disease."
Chemomab's Phase 2 SPRING trial (NCT04595825) is a
double-blind, placebo-controlled study assessing the safety and
tolerability of CM-101 in PSC patients. The trial is also measuring
a wide range of relevant biomarkers and physiological parameters.
Patient enrollment in the trial is advancing towards completion and
Chemomab anticipates reporting a top-line readout in the second
half of 2024.
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 NASH patients (NCT05824156) reported earlier this
year 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 Orphan
Drug designation from the FDA and Europe's EMA and is currently being evaluated
in PSC patients in the Phase 2 SPRING trial.
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 transplant 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 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
designed to neutralize 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 and a Phase 2
trial in primary sclerosing cholangitis patients is ongoing, with
top-line data expected in the second half of 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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