--CM-101's Unique Dual Anti-Fibrotic
and Anti-Inflammatory Activity Supports Its Disease Modifying
Potential in Primary Sclerosing Cholangitis (PSC)---
--CM-101 Phase 2 SPRING Trial in PSC is
Advancing Towards Completion of Enrollment with Topline Readout
Currently Targeted in Second Half of 2024--
TEL
AVIV, Israel, Sept. 28,
2023 /PRNewswire/ -- Chemomab Therapeutics Ltd.
(Nasdaq: CMMB), (Chemomab), a clinical stage biotechnology company
developing innovative therapeutics to treat rare fibro-inflammatory
diseases with high unmet need, today announced that Chemomab
co-founder, Chief Executive Officer and Chief Scientific Officer
Adi Mor, PhD, will discuss the
CM-101 clinical program in primary sclerosing cholangitis (PSC) at
the 2023 Roth MKM Healthcare Opportunities Conference on
October 12, 2023. The conference is
being held at the Yale Club in New York
City. Dr. Mor will give a live presentation at 12:00
noon ET and company executives will
participate in one-on-one meetings with investors.
Chemomab's first-in-class monoclonal antibody CM-101 neutralizes
CCL24, a novel target that has been shown to play a central role in
the processes that drive fibrosis and inflammation. CM-101 is
currently being assessed in the Phase 2 SPRING trial for the
treatment of PSC, with topline data expected in the second half of
2024.
PSC is a potentially lethal condition that lacks any
FDA-approved therapies and frequently requires liver transplant.
Unlike the other drugs in clinical development for PSC, CM-101 has
a unique dual mechanism of action that simultaneously blocks
fibrosis and inflammation. In extensive preclinical and early
clinical studies, this distinctive, multifaceted approach has been
shown to inhibit fibrogenesis and interfere with the core pathways
that result in the liver damage associated with PSC.
Earlier this year, Chemomab reported positive results from a
Phase 2a liver fibrosis trial in patients with nonalcoholic
steatohepatitis (NASH). A majority of patients treated with CM-101
demonstrated improvements in multiple biomarkers associated with
fibrosis and inflammation. A higher percentage of patients
responding to treatment with CM-101 had improvements in Enhanced
Liver Fibrosis (ELF) scores, liver stiffness as measured by
transient elastography, and PRO-C3 levels compared to placebo.
The ELF score, liver stiffness as measured by transient
elastography and PRO-C3, a marker of collagen III formation, have
all been identified as prognostic markers and independent
predictors of transplant-free survival and improved patient
outcomes in PSC. These results suggest that CM-101 possesses
anti-fibrotic properties in the liver that may also be relevant in
PSC, and Chemomab views these data as promising for a potentially
successful translation to the treatment of PSC.
The company's ongoing PSC Phase 2 SPRING trial is evaluating two
dose cohorts that are intended to provide high exposure to CM-101
(10 and 20mg/kg intravenously administered, compared to 5mg/kg via
subcutaneous injection in the liver fibrosis/NASH trial), as well
as an open-label extension providing for longer-term evaluation of
the effects of CM-101 treatment for up to 48 weeks, thereby
enhancing the opportunity for a more comprehensive assessment of
CM-101's therapeutic potential in PSC.
"We have reported a number of positive CM-101 developments this
year," said Dr. Mor. "First, we reported consistent, positive
biomarker data from our Phase 2 liver fibrosis trial in NASH
patients that we believe are directly relevant to PSC; second, we
presented several supportive preclinical PSC studies at major
scientific meetings and published a peer-reviewed scientific review
of the role of CCL24 in PSC; and third, the strong commitment of
PSC patients and clinicians to the Phase 2 SPRING trial is enabling
us to advance enrollment at a robust pace."
Dr. Mor added, "We consider the recent announcement of promising
results in Pliant's Phase 2 PSC study as a positive for the field,
highlighting the unmet need in PSC and the possible utility of
anti-fibrotic agents in this condition. Our continued clinical
progress in validating CM-101's unique dual anti-inflammatory and
anti-fibrotic activity reinforces our optimism that CM-101 may have
potential as a disease-modifying therapy for PSC. We look forward
to discussing the CM-101 PSC program at the upcoming Roth MKM
conference as we advance towards completing our Phase 2 trial and
reporting topline results in the coming year."
Attendance at the conference is by invitation only. To register
for the 2023 Roth-MKM Healthcare Opportunities Conference, click
here, or contact a Roth MKM sales representative.
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 is currently being evaluated in PSC patients in the Phase 2
SPRING trial (NCT04595825), with a topline readout expected in the
second half of 2024.
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 2 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
topline data expected in the second half of 2024. For more
information about 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
Company's cash position and expectations regarding its ability to
achieve the topline data readout from the Phase 2
primary sclerosing cholangitis (PSC)
trial of CM-101 with its current cash; 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:
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.