Contineum Therapeutics Announces Publication of Encouraging Data in the Proceedings of the National Academy of Sciences on PIPE-307, Its M1 Receptor Selective Inhibitor, in Clinical Development for Relapse-Remitting Multiple Sclerosis
31 Julio 2024 - 3:05PM
Business Wire
Contineum Therapeutics, Inc. (Nasdaq: CTNM), a clinical-stage
biopharmaceutical company focused on discovering and developing
novel, oral small molecule therapies that target biological
pathways associated with specific clinical impairments for the
treatment of neuroscience, inflammation and immunology (NI&I)
indications, today announced encouraging preclinical data on
PIPE-307, a potentially first-in-class M1 receptor antagonist in
development for patients with relapse-remitting multiple sclerosis
(RRMS), were published online in the peer-reviewed journal,
Proceedings of the National Academy of Science (PNAS).
The published data provide early evidence that PIPE-307 is a
potentially first-in-class, novel, small molecule, selective
inhibitor of the muscarinic type 1 M1 receptor. The full manuscript
is titled “Targeting the muscarinic M1 receptor with a selective,
brain-penetrant antagonist to promote remyelination in multiple
sclerosis” .
“We believe that PIPE-307 represents a differentiated and
clinically validated approach for the treatment of RRMS, and we are
pleased to have our innovative science validated by a high-quality
journal like PNAS,” said Carmine Stengone, President and CEO of
Contineum Therapeutics.
RRMS is the most common form of multiple sclerosis (MS). The
pathological hallmark of all forms of MS is the accumulation of
demyelinating lesions that occur in the brain and spinal cord. In
healthy neurons, myelin, which is a specialized extension of the
plasma membrane of oligodendrocytes, serves as an insulator that
allows for rapid and efficient conduction of electrochemical
signals along the axon. In demyelinating diseases, such as MS, loss
of myelin leads to slower signal transmission through the axon and
eventual permanent loss of neuronal function.
“As observed in our preclinical studies, we believe that the
immune-mediated effects of RRMS drive M1 signaling by increasing
the local concentration of acetylcholine which in turn, limits OPC
maturation and remyelination,” said Stephen Huhn, M.D., Chief
Medical Officer and Senior Vice President of Clinical Development
of Contineum Therapeutics. “The M1 receptor is highly expressed on
OPCs and, by blocking M1 and lifting this inhibitory brake on
maturation, we believe that PIPE-307 can lead to OPC maturation and
axon remyelination. We are pleased to have published these data in
PNAS and to have advanced into a multi-center Phase 2 study
investigating PIPE-307’s efficacy and safety in patients.”
The published data highlight the foundational preclinical
profile of PIPE-307 that supports Contineum’s ongoing Phase 2
clinical trial in RRMS. To date, Contineum has completed two Phase
1 clinical trials of PIPE-307 in healthy volunteers and has
initiated a Phase 2 multi-center, randomized, double-blind,
placebo-controlled proof-of-concept clinical trial in RRMS patients
(NCT06083753). This trial, named VISTA, will assess efficacy and
safety in patients with RRMS and is designed to measure multiple
clinical and imaging endpoints sensitive to changes in
remyelination in RRMS.
PIPE-307 is being developed pursuant to a global license and
development agreement with Janssen Pharmaceutica NV, one of the
Janssen Pharmaceutical Companies of Johnson & Johnson.
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 (MS) and PIPE-307, a
selective inhibitor of the M1 receptor, in clinical development for
relapse remitting MS. PIPE-307 is being developed pursuant to a
global license and development agreement between Contineum and
Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical
Companies of Johnson & Johnson, who plans to initiate a Phase 2
clinical trial of PIPE-307 in depression in 2024. Contineum is
headquartered in San Diego, CA. 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, the status and
potential of PIPE-307 as a differentiated, first-in-class, novel
approach for the treatment of RRMS, statements regarding the
Company’s plans for and the anticipated benefits of its drug
candidates, including PIPE-791 and PIPE-307, the timing, objectives
and results of the clinical trials, and the quotations of
Contineum’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; clinical
studies and preclinical studies may not proceed at the time or in
the manner expected, or at all; the timing and outcome of research,
development and regulatory review is uncertain; risks associated
with reliance on third parties to successfully conduct clinical
trials and, in the case of PIPE-307, the Company’s reliance, after
completion of the VISTA trial, upon Johnson and Johnson Innovative
Medicine’s decision, in its sole discretion, whether or not to
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 an
affiliate of Johnson & Johnson may not result in the successful
development of PIPE-307; and the Company may be unable to obtain,
maintain and enforce intellectual property protection for its
technology and drug candidates. 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/20240729449836/en/
Peter Slover, CFO IR@contineum-tx.com
Contineum Therapeutics (NASDAQ:CTNM)
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