- Second Phase 2 Study for Luvadaxistat Fails to Meet Primary
Endpoint as Potential Treatment for Cognitive Impairment Associated
with Schizophrenia
- Results Confounded by Variability in Cognition Measures
Across Population Studied and Potential Imbalance in Baseline
Characteristics of Enrolled Subjects
- Neurocrine Biosciences to Focus Resources on Phase 3
Clinical Development of NBI-1117568 for Schizophrenia and
NBI-1065845 for Major Depressive Disorder
SAN
DIEGO, Sept. 12, 2024 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (Nasdaq: NBIX) today announced that its ERUDITE™
Phase 2 clinical study of investigational compound luvadaxistat
(NBI-1065844) failed to meet its primary endpoint as a potential
treatment to improve cognitive impairment in patients with
schizophrenia.
The ERUDITE study was the second Phase 2 trial for luvadaxistat.
It failed to replicate the cognitive endpoints data seen in the
earlier INTERACT™ study, due in part to the large variability seen
in the cognitive measures across the population studied and a
potential imbalance in the baseline characteristics of subjects
enrolled across the treatment arms.
In the INTERACT study, 50 mg luvadaxistat resulted in a
statistically significant improvement in measure of cognition on
the Brief Assessment of Cognition in Schizophrenia (BACS) and
cognitive performance on the Schizophrenia Cognition Rating Scale
(SCoRS). The INTERACT study represented the first time statistical
significance had been demonstrated for both cognitive measure and
function within a single study.
"While it's disappointing that luvadaxistat did not meet the
primary endpoint in this study, we understand the challenges and
hurdles that exist in identifying potential medicines for the
treatment of cognitive impairment in schizophrenia. We therefore
plan to halt further development of luvadaxistat at this time and
instead will focus our efforts and resources on the advancement
into Phase 3 clinical development of NBI-1117568 for schizophrenia
and NBI-1065845 for major depressive disorder," said Eiry W.
Roberts, M.D., Chief Medical Officer. "We are excited by the
opportunity that lies ahead of us to bring forward potential
medicines for patients in these important areas of unmet need in
neuropsychiatry."
About Luvadaxistat
Luvadaxistat (NBI-1065844) is an
investigational, oral, selective inhibitor with a high binding
affinity to d-amino acid oxidase (DAAO), which metabolizes
D-Serine, a primary NMDA receptor co-agonist in the limbic region
of the brain. In schizophrenia, N-methyl D-aspartate (NMDA)
receptor hypofunction on PV+ gamma-aminobutyric acid
(GABA) interneurons results in disinhibition of cortical or
hippocampal glutamate neurons projecting to the pyramidal neurons,
which are associated with cognitive impairment seen in
schizophrenia.
The ERUDITE™ Phase 2 clinical study is a randomized,
double-blind, placebo-controlled, parallel group study to evaluate
the efficacy safety and tolerability of luvadaxistat in adults with
cognitive impairment associated with schizophrenia (CIAS). For more
information about this study, visit ClinicalTrials.gov.
Neurocrine Biosciences acquired the rights to develop and
commercialize luvadaxistat from Takeda Pharmaceutical Company,
Ltd.
About Schizophrenia
Schizophrenia is a serious and
complex syndrome with heterogeneous symptoms. This chronic and
disabling mental health condition is thought to result from a
complex interplay of genetic and environmental risk factors. The
World Health Organization estimates that the disorder impacts more
than 20 million people worldwide. Annual associated costs for
schizophrenia are estimated to be more than $150 billion in the
United States. It is estimated that approximately 80 percent
of people living with schizophrenia have cognitive impairment
associated with schizophrenia (CIAS).
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)
The NEUROCRINE BIOSCIENCES Logo Lockup and YOU DESERVE BRAVE
SCIENCE are registered trademarks of Neurocrine Biosciences, Inc.
INTERACT and ERUDITE are 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 related to the clinical
results from, and our future development plans with respect to
luvadaxistat. 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, 2024. 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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