SAN
DIEGO, March 28, 2024 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (Nasdaq: NBIX), today announced the initiation of
its Phase 1 clinical study to evaluate the safety, tolerability,
pharmacokinetics, and pharmacodynamics of investigational compound
NBI-1065890 in healthy adult participants. NBI-1065890 is an
investigational, oral, selective inhibitor of the vesicular
monoamine transporter-2 (VMAT2) for the potential treatment of
certain neurological and neuropsychiatric conditions.
"Neurocrine has deep scientific expertise and experience in
VMAT2 inhibition, exemplified by the 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. "We're excited to
bring this next-generation, internally discovered, highly potent,
oral, selective VMAT2 inhibitor into the clinic with the hope of
providing differentiated benefit in treating certain neurological
and neuropsychiatric conditions."
VMAT2 small molecule 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.
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, 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 (formerly Twitter), and Facebook.
(*in collaboration with AbbVie)
NEUROCRINE BIOSCIENCES, NEUROCRINE, and YOU DESERVE BRAVE
SCIENCE are registered trademarks of Neurocrine Biosciences, Inc.
The Neurocrine logo is a trademark 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-1065890. 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 annual report on Form
10-K for the year ended December 31,
2023. Neurocrine Biosciences disclaims any obligation to
update the statements contained in this press release after the
date hereof other than required by law.
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SOURCE Neurocrine Biosciences, Inc.