SAN
DIEGO, Sept. 11, 2023 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (Nasdaq: NBIX), today announced the initiation of
its Phase 1 first-in-human clinical study to evaluate the safety,
tolerability, pharmacokinetics, and pharmacodynamics of
investigational compound NBI-1117570 in healthy adult participants.
NBI-1117570 is an investigational, oral, muscarinic M1/M4 selective
dual agonist that may have the potential to treat neurological and
neuropsychiatric conditions.
"Initiation of this Phase 1 study represents an important step
forward for NBI-1117570, a potentially first-in-class, orally
active, selective investigational dual M1/M4 agonist," said Eiry W.
Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences.
"The selectivity profile of NBI-1117570 in targeting M1 and M4
receptors may provide an opportunity to treat symptoms of both
psychosis and cognition across a broad range of neurological and
neuropsychiatric conditions."
About NBI-1117570
NBI-1117570 is an investigational,
oral, muscarinic M1/M4 dual agonist. Muscarinic receptors are
fundamental to activating signaling pathways in the brain. There
are five muscarinic acetylcholine receptors involved in
neurotransmission, two of which are selectively targeted by
NBI-1117570 (M1 and M4), with M1 validated as a potential drug
target in cognition and M4 in psychosis for clinical drug
development. Neurocrine Biosciences acquired the rights to develop
and commercialize NBI-1117570 from Sosei Heptares.
About Neurocrine Biosciences
Neurocrine Biosciences is a leading neuroscience-focused,
biopharmaceutical company with a simple purpose: to relieve
suffering for people with great needs, but few options. We are
dedicated to discovering and developing life-changing treatments
for patients with under-addressed neurological, neuroendocrine and
neuropsychiatric disorders. The company's diverse portfolio
includes FDA-approved treatments for tardive dyskinesia, chorea
associated with Huntington's disease, Parkinson's disease,
endometriosis* and uterine fibroids*, as well as a robust pipeline
including multiple compounds in mid- to late-phase clinical
development across our core therapeutic areas. For three decades,
we have applied our unique insight into neuroscience and the
interconnections between brain and body systems to treat complex
conditions. We relentlessly pursue medicines to ease the burden of
debilitating diseases and disorders, because you deserve brave
science. For more information, visit neurocrine.com, and
follow the company on LinkedIn, Twitter, and Facebook.
(*in collaboration with AbbVie)
NEUROCRINE and the Neurocrine logo are registered trademarks of
Neurocrine Biosciences, Inc.
Forward-Looking Statement
In addition to historical
facts, this press release contains forward-looking statements that
involve a number of risks and uncertainties. These statements
include, but are not limited to, statements related to the
potential benefits of NBI-1117570. Among the factors that could
cause actual results to differ materially from those indicated in
the forward-looking statements are: risks that clinical development
activities may not be initiated or completed on time or at all, or
may be delayed for regulatory, manufacturing, or other reasons, may
not be successful or replicate previous clinical trial results, may
fail to demonstrate that our product candidates are safe and
effective, or may not be predictive of real-world results or of
results in subsequent clinical trials; our future financial and
operating performance; risks associated with our dependence on
third parties for development, manufacturing, and commercialization
activities for our products and product candidates, and our ability
to manage these third parties; risks that the FDA or other
regulatory authorities may make adverse decisions regarding our
products or product candidates; risks that the potential benefits
of the agreements with our collaboration partners may never be
realized; risks that our products, and/or our product candidates
may be precluded from commercialization by the proprietary or
regulatory rights of third parties, or have unintended side
effects, adverse reactions or incidents of misuse; risks associated
with U.S. federal or state legislative or regulatory and/or policy
efforts which may result in, among other things, an adverse impact
on our revenues or potential revenue; risks associated with
potential generic entrants for our products; and other risks
described in the Company's periodic reports filed with the
Securities and Exchange Commission, including without limitation
the Company's quarterly report on Form 10-Q for the quarter ended
June 30, 2023. Neurocrine Biosciences
disclaims any obligation to update the statements contained in this
press release after the date hereof.
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SOURCE Neurocrine Biosciences, Inc.