Aptinyx Initiates Phase 2 Study of NYX-458 in Patients with Mild Cognitive Impairment Associated with Parkinson’s Disease
December 05 2019 - 6:58AM
Aptinyx Inc. (Nasdaq: APTX), a clinical-stage biopharmaceutical
company developing transformative therapies for the treatment of
brain and nervous system disorders, today announced the initiation
of a Phase 2 clinical study of its novel NMDA receptor modulator,
NYX-458, for the treatment of mild cognitive impairment associated
with Parkinson’s disease. The company expects to report top-line
data from the 135-patient Phase 2 study in the second half of 2021.
“The initiation of this study marks an important milestone as we
seek to bring a better therapeutic option to patients suffering
from cognitive impairment,” said Norbert Riedel, Ph.D., president
and chief executive officer of Aptinyx. “Based on the striking
reversal of cognitive deficits we observed with NYX-458 in a
non-human primate model of Parkinson’s disease, as well as the
favorable safety we observed in a Phase 1 study, we are excited
about the potential for NYX-458 to alleviate the cognitive
impairment associated with Parkinson’s disease.”
“While motor symptoms represent the classical features of
Parkinson’s patients, more than half of all people suffering from
the disease are also afflicted by cognitive symptoms,” said C.
Warren Olanow, M.D., chief executive officer of CLINTREX, professor
emeritus in the Departments of Neurology and Neuroscience at the
Mount Sinai School of Medicine, and renowned Parkinson’s expert.
“The neurodegeneration that occurs in Parkinson’s disease is
believed to cause a disruption in NMDA receptor processes that are
critical for normal cognitive function. If NYX-458 can address
these aberrant processes, it could prove to be an important
therapeutic advance, as currently available therapies for treating
cognitive symptoms in PD have limited efficacy. Indeed, no therapy
has been approved for the treatment of MCI in PD, which remains a
substantial unmet need.”
About the Phase 2 Cognitive Impairment in Parkinson’s
Disease StudyThe Phase 2 study is a randomized,
double-blind, parallel-design, placebo-controlled study to evaluate
the safety and potential cognitive benefits of NYX-458 in
approximately 135 patients with mild cognitive impairment
associated with Parkinson’s disease. The study will evaluate daily
oral dosing of NYX-458—10 mg, 30 mg, or 100 mg—compared to placebo
over a 12-week period. The effects of NYX-458 on cognitive
performance will be evaluated across multiple endpoints related to
attention, memory, executive function, visuospatial deficits, and
patient quality of life. Aptinyx anticipates reporting top-line
data from this study in the second half of 2021.
About Cognitive Impairment Associated with Parkinson’s
DiseaseCognitive impairment affects approximately half of
patients with Parkinson’s disease. It is believed that the loss of
dopamine, which is known to be associated with the motor symptoms
of the disease, leads to dysregulation in processes that are
important for cognitive function. Cognitive impairment associated
with Parkinson’s disease is distinct from other forms of dementia
in that it often presents as deficits in one or two cognitive
domains. Attention, memory, executive functioning, and visuospatial
function are the most disrupted domains in people with Parkinson’s
disease.
About NYX-458NYX-458 is a novel oral NMDA
receptor modulator currently in clinical development for the
treatment of cognitive impairment associated with Parkinson’s
disease. NYX-458 has been shown to reverse cognitive deficits in
non-human primates in a model that is highly translatable to
Parkinson’s disease in humans. NYX-458 has also been shown to
improve cognitive performance across various other preclinical
models of neurodegeneration. In a Phase 1 clinical study, NYX-458
exhibited a favorable safety and tolerability profile across a wide
dose range and achieved CNS exposures consistent with exposures
observed at efficacious preclinical dose levels.
About AptinyxAptinyx Inc. is a clinical-stage
biopharmaceutical company focused on the discovery, development,
and commercialization of proprietary synthetic small molecules for
the treatment of brain and nervous system disorders. Aptinyx has a
platform for discovery of novel compounds that work through a
unique mechanism to modulate—rather than block or
over-activate—NMDA receptors and enhance synaptic plasticity, the
foundation of neural cell communication. The company has three
product candidates in clinical development in central nervous
system indications, including chronic pain, post-traumatic stress
disorder, and cognitive impairment associated with Parkinson’s
disease. Aptinyx is also advancing additional compounds from its
proprietary discovery platform, which continues to generate a rich
and diverse pipeline of small-molecule NMDA receptor modulators
with the potential to treat an array of neurologic disorders. For
more information, visit www.aptinyx.com.
Forward-Looking StatementsStatements contained
in this press release regarding matters that are not historical
facts are “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995. Because such
statements are subject to risks and uncertainties, actual results
may differ materially from those expressed or implied by such
forward-looking statements. Such statements include, but are not
limited to, statements regarding the company’s business plans and
objectives, including future plans or expectations for NYX-458,
therapeutic effects of the company’s product candidates,
expectations regarding the design, implementation, timing, and
success of its current and planned clinical trials, expectations
regarding its preclinical development activities, and expectations
regarding its uses and sufficiency of capital. Risks that
contribute to the uncertain nature of the forward-looking
statements include: the success, cost, and timing of the company’s
product candidate development activities and planned clinical
studies; the company’s ability to execute on its strategy;
regulatory developments in the United States and foreign countries;
as well as those risks and uncertainties set forth in the company’s
most recent annual report on Form 10-K and in its other filings and
reports with the United States Securities and Exchange Commission.
All forward-looking statements contained in this press release
speak only as of the date on which they were made. Aptinyx
undertakes no obligation to update such statements to reflect
events that occur or circumstances that exist after the date on
which they were made.
Investor and Media Contact:Nick SmithAptinyx
Inc.ir@aptinyx.com or corporate@aptinyx.com847-871-0377
Source: Aptinyx Inc.
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