Contineum Therapeutics Initiates Patient Dosing in Phase 1b Positron Emission Tomography (PET) Trial of PIPE-791
December 16 2024 - 4:05PM
Business Wire
- Phase 1b trial will evaluate receptor
occupancy of PIPE-791 in the brain and lungs of patients in
multiple cohorts using a PET tracer of the LPA1 receptor
- Topline data readout planned for the second
quarter of 2025
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 dosing of the
first cohort of patients in the PIPE-791 Phase 1b positron emission
tomography (PET) trial. PIPE-791 is a novel, brain penetrant, small
molecule antagonist of the lysophosphatidic acid 1 receptor
(LPA1R).
The Phase 1b, open label, single-center trial is expected to
measure the correlation of pharmacokinetics to receptor occupancy
by PET imaging in healthy volunteers, as well as idiopathic
pulmonary fibrosis (IPF) and progressive multiple sclerosis (PrMS)
patients. Contineum anticipates topline data from the PIPE-791
Phase 1b PET trial in the second quarter of 2025. More information
on this trial can be found at https://clinicaltrials.gov
(NCT06683612).
“Initiating dosing in this trial brings us closer to a
potentially new, first-in-class treatment for IPF and PrMS
patients,” said Stephen Huhn, Chief Medical Officer, Contineum
Therapeutics. “We expect this trial will establish a
pharmacokinetic/pharmacodynamic (PK/PD) link between PIPE-791 and
LPA1 receptor occupancy in healthy volunteers, as well as
demonstrate target engagement in the disease setting of IPF and
PrMS. The results of the Phase 1b PET trial will inform dose
selection of our future trials in both indications.”
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, progressive multiple sclerosis and chronic pain, 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 timing of
the topline data readout from the PIPE-791 Phase 1b PET trial;
whether the results of the Phase 1b PET trial will be predictive of
the dose selection for, or results generated in, future clinical
trials of PIPE-791; 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 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/20241216396391/en/
Steve Kunszabo Contineum Therapeutics Senior Director, Investor
Relations & Corporate Communications 858-649-1158
skunszabo@contineum-tx.com
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