Contineum Therapeutics Completes Enrollment in Phase 2 PIPE-307 VISTA Trial for the Treatment of Relapsing-Remitting Multiple Sclerosis (RRMS)
January 08 2025 - 3:05PM
Business Wire
- Targeted enrollment of 168 RRMS patients
achieved in December 2024 - The last patient is expected to
complete the trial in the third quarter of 2025
Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the
Company), a clinical-stage biopharmaceutical company pioneering
differentiated therapies for the treatment of neuroscience,
inflammation and immunology (NI&I) indications, today announced
that it has completed the targeted enrollment of 168 patients in
its Phase 2 PIPE-307 VISTA trial. PIPE-307 is a potentially
first-in-class M1 receptor antagonist in development for patients
with relapsing-remitting multiple sclerosis (RRMS).
The Phase 2, randomized, double-blind, placebo-controlled,
multi-center, proof-of-concept trial of PIPE-307 will assess safety
and efficacy in RRMS patients. The trial is designed to measure
multiple clinical and imaging endpoints sensitive to changes in
remyelination in RRMS. Contineum anticipates that the last patient
will complete the PIPE-307 VISTA trial in the third quarter of
2025. More information on this trial can be found at
https://clinicaltrials.gov (NCT06083753).
“We are pleased to reach this significant milestone for the
PIPE-307 VISTA trial ahead of schedule,” said Stephen Huhn, Chief
Medical Officer, Contineum Therapeutics. “The trial is designed to
show evidence of remyelination as a potentially first-in-class and
differentiated therapy for RRMS patients. We believe that PIPE-307
could represent the next evolution in the treatment paradigm for
RRMS. We are grateful for the VISTA trial investigators, patients
and their families, and we look forward to sharing topline data
from this trial.”
PIPE-307 is being developed pursuant to a global license and
development agreement between Contineum and Janssen Pharmaceutica
NV, a Johnson & Johnson company.
About Contineum Therapeutics
Contineum Therapeutics (Nasdaq: CTNM) is a clinical-stage
biopharmaceutical company pioneering novel, oral small molecule
therapies for NI&I indications with significant unmet need.
Contineum is advancing a pipeline of internally-developed programs
with multiple drug candidates now in clinical trials. PIPE-791 is
an LPA1 receptor antagonist in clinical development for idiopathic
pulmonary fibrosis, progressive multiple sclerosis and chronic
pain, and PIPE-307, is a selective inhibitor of the M1 receptor for
relapsing-remitting multiple sclerosis (RRMS). 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 timing of
the topline data from the VISTA trial; 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 trials 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 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 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/20250108107473/en/
Steve Kunszabo Contineum Therapeutics Senior Director, Investor
Relations & Corporate Communications 858-649-1158
skunszabo@contineum-tx.com
Contineum Therapeutics (NASDAQ:CTNM)
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