- Phase 1b study for the potential treatment of
osteoarthritis and low back pain expected to commence in the first
quarter of 2025 - Initial data readout planned for early 2026 -
Neuropathic component of chronic pain linked to LPA1 activation
Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the
Company), a clinical stage biopharmaceutical company focused on
discovering and developing novel, oral small molecule therapies
that target biological pathways associated with specific clinical
impairments in the treatment of neuroscience, inflammation and
immunology (NI&I) indications, today announced authorization of
its Investigational New Drug (IND) application from the U.S. Food
and Drug Administration (FDA) for PIPE-791 for the treatment of
chronic pain associated with two separate indications,
osteoarthritis (OA) and low back pain (LBP). PIPE-791 is a novel,
brain penetrant, small molecule antagonist of the lysophosphatidic
acid 1 receptor (LPA1R).
The exploratory Phase 1b, randomized, double-blind,
placebo-controlled, crossover, multi-center study is expected to
begin in the first quarter of 2025. The Company expects to enroll
approximately 40 patients at up to five sites, and a treatment
duration of 28 days. Contineum anticipates topline data from the
PIPE-791 Phase 1b chronic pain study in early 2026.
“We’re pleased to expand PIPE-791 clinical development to
include the potential treatment of chronic pain in a limited,
exploratory, signal-seeking study,” said Carmine Stengone, CEO,
Contineum Therapeutics. “Researchers have shown that LPA pathways
have been specifically implicated in the neuropathic components of
preclinical pain models and clinical biomarker studies. This is a
first step to evaluate how PIPE-791 may provide a potentially
differentiated, non-opioid treatment option for patients with OA
and LBP.”
Chronic pain is often associated with neuropathic symptoms
caused by aberrant signaling in the central nervous system (CNS)
leading to heightened sensitivity to painful stimuli. LPA1
activation has been shown to contribute to persistent
hypersensitivity, characteristic of neuropathic pain, by promoting
the demyelination of nerve fibers, increasing neuronal excitability
and enhancing neuroinflammatory responses in the CNS (Company
research, Ueda 2020). By selectively blocking LPA1 receptor
activity, an LPA1 antagonist may prevent or reverse the maladaptive
changes in the nervous system that initiate and maintain the
chronic pain state.
OA is the most common joint disease characterized by chronic
pain and decreased mobility. OA affects approximately 33 million
people in the United States. Current pharmacological treatments for
pain associated with OA consist of non-steroidal anti-inflammatory
drugs (NSAIDs), topical agents, antidepressants and steroid
injections.
LBP is a common musculoskeletal condition that can be associated
with spinal degeneration, nerve compression and inflammation. Low
back pain affects approximately 45 million people in the United
States. Over-the-counter or prescription NSAIDs, antidepressants,
steroid injections, muscle relaxants and opioids are commonly used
for pain and inflammation reduction.
With the addition of the PIPE-791 Phase 1b chronic pain study,
the Company continues to expect its cash, cash equivalents and
marketable securities of $213.9 million as of September 30, 2024,
are sufficient to fund its planned operations through 2027.
About Contineum Therapeutics
Contineum Therapeutics (Nasdaq: CTNM) is a clinical stage
biopharmaceutical company focused on discovering and developing
novel, oral small molecule therapies for NI&I indications with
high unmet need. Contineum is focused on targeting biological
pathways associated with specific clinical impairments, that
Contineum believes, once modulated, may demonstrably impact the
course of disease. Contineum has a pipeline of internally-developed
programs to address multiple NI&I disorders. Contineum has two
drug candidates in clinical trials, PIPE-791, an LPA1 receptor
antagonist in clinical development for idiopathic pulmonary
fibrosis and progressive multiple sclerosis, and PIPE-307, a
selective inhibitor of the M1 receptor in clinical development for
relapsing-remitting multiple sclerosis (RRMS). PIPE-307 is being
developed pursuant to a global license and development agreement
between Contineum and Janssen Pharmaceutica NV, a Johnson &
Johnson company, who has also announced plans to initiate a Phase 2
trial of PIPE-307 in depression in 2024. For more information,
please visit www.contineum-tx.com.
Forward-Looking Statements
Certain statements contained in this press release, other than
historical information, constitute forward-looking statements
within the meaning of the federal securities laws. Forward-looking
statements include, but are not limited to, statements regarding
the Company’s clinical trial and product development plans and
timelines, including, but not limited to, the expected initiation
of the PIPE-791 chronic pain study and the timing thereof; the
design and goals of the PIPE-791 chronic pain study; the expected
timing of the topline data from the PIPE-791 chronic pain study;
the indications, anticipated benefits of, and market opportunities
for its drug candidates; its cash runway; its business strategies
and plans; and the quotations of the Company’s management. These
statements involve known and unknown risks, uncertainties and other
important factors that are in some cases beyond the Company’s
control and may cause its actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by the
forward-looking statements. These risks and uncertainties, include,
but are not limited to, the following: the Company is heavily
dependent on the success of PIPE-791 and PIPE-307, both of which
are in the early stages of clinical development, and neither of
these drug candidates may progress through clinical development or
receive regulatory approval; the results of earlier preclinical
studies and clinical trials, including those conducted by third
parties, may not be predictive of future results and unexpected
adverse side effects or inadequate efficacy of the Company’s drug
candidates may limit their development, regulatory approval and/or
commercialization; the timing and outcome of research, development
and regulatory review is uncertain; clinical studies and
preclinical studies may not proceed at the time or in the manner
expected, or at all; the potential for our programs and prospects
to be negatively impacted by developments relating to our
competitors, including the results of studies or regulatory
determinations relating to our competitors; risks associated with
reliance on third parties to successfully conduct clinical trials
and, in the case of PIPE-307, the Company’s reliance upon Johnson
& Johnson to develop PIPE-307 for depression or any other
indication other than RRMS and, after completion of the VISTA
trial, Johnson and Johnson’s decision, in its sole discretion,
whether or not further develop PIPE-307 for RRMS; the Company has
incurred significant operating expenses since inception and it
expects that its operating expenses will continue to significantly
increase for the foreseeable future; the Company’s license
agreement with Johnson & Johnson may not result in the
successful development of PIPE-307; the Company may be unable to
obtain, maintain and enforce intellectual property protection for
its technology and drug candidates; and unstable market and
economic conditions and military conflict may adversely affect our
business and financial condition and the broader economy and
biotechnology industry. Additional risks and uncertainties that
could affect the Company’s business, operations and results are
included under the captions, “Risk Factors” and "Management’s
Discussion and Analysis of Financial Condition and Results of
Operations” in its most recent filing on Form 10-Q and in other
filings that it makes with the SEC from time to time. These
documents are available on the Company’s website at
www.contineum-tx.com under the Investor section and on the SEC’s
website at www.sec.gov. Accordingly, readers should not rely upon
forward-looking statements as predictions of future events. Except
as required by applicable law, the Company undertakes no obligation
to update publicly or revise any forward-looking statements
contained herein, whether as a result of any new information,
future events, changed circumstances or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20241114778987/en/
Steve Kunszabo Contineum Therapeutics Senior Director, Investor
Relations & Corporate Communications 858-649-1158
skunszabo@contineum-tx.com
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