SAN
DIEGO, April 3, 2024 /PRNewswire/
-- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced
that the first patient has been randomized for its Phase 2 clinical
study to evaluate the efficacy, safety, and tolerability of
investigational compound NBI-1070770 in adults with major
depressive disorder. NBI-1070770 is a novel, selective, and orally
active, negative allosteric modulator (NAM) of the NR2B
subunit-containing N-methyl-D-aspartate (NMDA NR2B) receptor.
"Based upon our Phase 1 first-in-human study, we are excited to
bring this novel oral compound, which acts through a clinically
validated mechanism of action, into clinical development as a
potential treatment for major depressive disorder," said Eiry W.
Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences.
"The selectivity of NBI-1070770 for the NMDA NR2B receptor has the
potential to benefit patients who have moderate to severe
depression."
The NBI-1070770 Phase 2 multi-center, randomized, double-blind,
placebo-controlled study will enroll approximately 72 adults and is
being conducted at centers throughout the United States. The study will evaluate the
safety and efficacy of NBI-1070770 in subjects with major
depressive disorder compared to placebo on improving symptoms of
depression as measured by the Montgomery-Åsberg Depression Rating
Scale. For more information about the Phase 2 study
(NBI-1070770-MDD2029), visit Clinicaltrials.gov.
Neurocrine Biosciences acquired the rights to develop and
commercialize NBI-1070770 from Takeda Pharmaceutical Company,
Ltd.
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-1070770. 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.