SAN
DIEGO, March 5, 2025 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (Nasdaq: NBIX) today announced the initiation of
a Phase 1 clinical study to evaluate the safety, tolerability,
pharmacokinetics and pharmacodynamics of investigational compound
NBI-1140675 in healthy adult participants. NBI-1140675 is an
investigational, oral, selective second-generation small molecule
inhibitor of the vesicular monoamine transporter 2 (VMAT2) in
development for the potential treatment of certain neurological and
neuropsychiatric conditions.
"We are focused on extending our bench of VMAT2 inhibitors in
development, building on our successful discovery and development
of valbenazine for the treatment of tardive dyskinesia and chorea
in Huntington's disease," said Eiry W. Roberts, M.D., Chief Medical
Officer at Neurocrine Biosciences. "NBI-1140675 is an internally
discovered, highly potent, selective VMAT2 inhibitor with the
potential to provide differentiated benefit in treating certain
neurological and neuropsychiatric conditions."
NBI-1140675 joins NBI-1065890 as a second-generation VMAT2
inhibitor undergoing evaluation by Neurocrine in Phase 1
clinical studies. VMAT2 inhibitors have been clinically validated
as effective treatments for hyperkinetic movement disorders,
playing an important role in presynaptic dopamine storage and
release. Neurocrine successfully developed and received U.S. Food
and Drug Administration approval in 2017 for valbenazine, a
selective VMAT2 inhibitor, for use as the first drug ever developed
for the treatment of tardive dyskinesia. In 2023, the company
received FDA approval for valbenazine as a treatment for chorea
associated with Huntington's disease. Valbenazine is in Phase 3
clinical studies as an adjunctive treatment with antipsychotics for
schizophrenia and as a treatment for dyskinetic cerebral palsy.
About Neurocrine Biosciences
Neurocrine Biosciences is a leading neuroscience-focused,
biopharmaceutical company with a simple purpose: to relieve
suffering for people with great needs. 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, classic congenital adrenal
hyperplasia, 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, X,
and Facebook.
(*in collaboration with AbbVie)
NEUROCRINE, the NEUROCRINE BIOSCIENCES Logo, and YOU DESERVE
BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences,
Inc.
Forward-Looking Statements
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 regarding the efficacy
and therapeutic potential of NBI-1140675. Factors could cause
actual results to differ materially from those stated or implied in
the forward-looking statements include, but are not limited to, the
following: 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; risks that regulatory submissions for
our product candidates may not occur or be submitted in a timely
manner; 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 annual report on Form
10-K for the year ended December 31,
2024. Neurocrine Biosciences disclaims any obligation to
update the statements contained in this press release after the
date hereof other than required by law.
© 2025 Neurocrine Biosciences. Inc. All Rights Reserved.
CAP-NBI-US-0134 03/2025
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SOURCE Neurocrine Biosciences, Inc.
