- SAVITRI™ Study Met Primary Endpoint with
Statistically Significant Reduction in Montgomery Åsberg Depression
Rating Scale (MADRS) Total Score at Day
28
- Met Key Secondary Endpoints, Including Statistically
Significant Reduction in MADRS Score at Day 56
- NBI-1065845 Was Generally Well-Tolerated
SAN
DIEGO, April 23, 2024 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (Nasdaq: NBIX), today announced positive topline
data for its Phase 2 SAVITRI™ study. This randomized, double-blind,
placebo-controlled dose-finding study assessed the efficacy and
safety of NBI-1065845 in adult subjects with major depressive
disorder (MDD). NBI-1065845 is an investigational
alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA)
positive allosteric modulator (PAM) in development as a potential
treatment for patients with MDD who have not benefited from
treatment with at least one antidepressant in their current episode
of depression.
The study met its primary and key secondary endpoints,
demonstrating that once-daily, oral administration of NBI-1065845
produced a statistically significant change from baseline in
Montgomery Åsberg Depression Rating Scale (MADRS) total score at
both Day 28 (primary) and Day 56 (secondary). In the full analysis
data set, the least squares (LS) mean differences from baseline in
MADRS total score for NBI-1065845 were:
- One of the doses demonstrated an improvement over placebo of
-4.3 (p-value = 0.0159) and -7.5 (p-value = 0.0016) at Day 28 and
Day 56, respectively.
- The other dose also demonstrated a trend toward improvement
over placebo of -3.0 (p-value = 0.0873) and -3.6 (p-value = 0.1082)
at Day 28 and Day 56, respectively.
NBI-1065845 was generally well tolerated. The most common
adverse event was headache. The adverse event profile for both
doses of NBI-1065845 were comparable to placebo. There were no
deaths or serious adverse events. The discontinuation rates were
low throughout the study.
"Many millions of people living with major depressive disorder
do not benefit fully from currently available treatments and
experience persistent debilitating symptoms," said Eiry W. Roberts,
M.D., Chief Medical Officer at Neurocrine Biosciences. "NBI-1065845
has the potential to be a first-in-class treatment to alleviate
many of these symptoms of MDD. The Phase 2 data from the
SAVITRI study are very encouraging, and we look forward to meeting
with the FDA to discuss a path into Phase 3 studies."
Additional data from the SAVITRI study will be shared at a
future scientific conference.
About the Phase 2 SAVITRI™ Study
The Phase 2 SAVITRI™
study is a double-blind, placebo-controlled study designed to
assess the efficacy and safety of investigational NBI-1065845 in
adult subjects with major depressive disorder (MDD). The study
enrolled 183 adults with a primary diagnosis of MDD and who had
inadequate response to current antidepressant treatment.
About NBI-1065845
NBI-1065845 is a potential
first-in-class, investigational
alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA)
positive allosteric modulator (PAM) in development as a potential
treatment for patients with inadequate response to treatment in
MDD.
About the Collaboration with Takeda
In 2020,
Neurocrine Biosciences and Takeda (TSE:4502/NYSE:TAK) entered into
a strategic collaboration to develop and commercialize compounds in
Takeda's early-to-mid-stage psychiatry pipeline, including an
exclusive license to NBI-1065845 (TAK-653). Under the terms of the
agreement, Neurocrine Biosciences is responsible for developing and
commercializing all compounds included in the collaboration and for
compounds other than NBI-1065845 and NBI-1065846, Takeda is
eligible to receive development or commercial milestone payments
and royalties. For NBI-1065845 and NBI-1065846, Takeda may
elect to opt out of a 50:50 profit share at certain development
events on a program-by-program basis. Until such time
Takeda elects to opt out of either profit share
arrangement, it will not be eligible to receive development or
commercial milestone payments.
About Major Depressive Disorder
Major depressive
disorder (MDD) is a mental health disorder characterized by a
persistently depressed mood, loss of interest, lack of enjoyment in
daily activities, poor concentration, and decreased energy. MDD is
one of the leading causes of disability. More than 21 million
people in the U.S. live with major depressive disorder. It is
estimated that roughly 1/3 of people living with major depressive
disorder do not respond to available antidepressants.
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 and SAVITRI are 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 regarding the clinical results from, and our future
development plans with respect to, NBI-1065845, as well as the
therapeutic potential and clinical benefits or safety profile of
NBI-1065845. Among the factors that could cause actual results to
differ materially from those indicated in the forward-looking
statements include: top-line data that we report may change
following a more comprehensive review of the data related to the
clinical studies and such data may not accurately reflect the
complete results of the clinical study; risks that regulatory
submissions for our products and/or product candidates may not
occur or be submitted in a timely manner; our products and/or
product candidates may not obtain regulatory approvals; or that
the U.S. Food and Drug Administration or regulatory
authorities outside the U.S. may make adverse decisions
regarding our products and/or product candidates; our products
and/or product candidates will not be found to be safe and/or
effective or may not prove to be beneficial to patients; that
development activities for our products and/or product candidates
may not be completed on time or at all; that clinical development
activities may be delayed for regulatory or other reasons, may not
be successful or replicate previous and/or interim clinical trial
results, or may not be predictive of real-world results or of
results in subsequent clinical trials; competitive products and
technological changes that may limit demand for our products;
uncertainties relating to patent protection and intellectual
property rights of third parties; our dependence on third parties
for development and manufacturing activities related to our
products and our product candidates, and our ability to manage
these third parties; our future financial and operating
performance; risks and uncertainties associated with the
commercialization of 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.
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SOURCE Neurocrine Biosciences, Inc.