Aptinyx Recommences Phase 2 Study of NYX-458 in Patients with Cognitive Impairment Associated with Parkinson’s Disease Deme...
April 06 2021 - 6:37AM
Business Wire
Patient screening has resumed following
temporary suspension due to escalation of the COVID-19 pandemic
Data readout from the Phase 2 cognitive
impairment study expected in 2H 2022
Three Phase 2 data readouts expected over the
next 12 to 18 months across the company’s clinical development
pipeline
Aptinyx Inc. (Nasdaq: APTX), a clinical-stage biopharmaceutical
company developing transformative therapies for the treatment of
brain and nervous system disorders, today announced that it has
recommenced patient screening in a Phase 2 study of NYX-458 in
patients with mild cognitive impairment and mild dementia
associated with Parkinson’s disease and dementia with Lewy bodies.
The company anticipates reporting data from this study in the
second half of 2022.
“We are pleased to be moving forward in evaluating NYX-458 in
patients suffering from cognitive impairment,” said Norbert Riedel,
Ph.D., chief executive officer of Aptinyx. “Current therapies for
these patients often do not deliver meaningful benefits and there
is a great need for new therapeutic options. We believe the
mechanism of NYX-458 is uniquely suited to address the cognitive
deficits experienced by these patients and we look forward to
building on the compelling preclinical data we have garnered with
NYX-458 to date.”
“Misfolded alpha-synuclein deposition can lead to NMDA glutamate
receptor dysfunction and contribute to cognitive deficits that
characterize patients with Parkinson’s disease dementia and
dementia with Lewy bodies,” said Peter LeWitt M.D., Professor of
Neurology at Wayne State University School of Medicine. “Modulation
of NMDA glutamate receptors to address this underlying disease
pathology is a compelling approach to treating the broad spectrum
of symptoms associated with cognitive impairment. I look forward to
seeing the data from this study, which offers a first step in
understanding the potential for NYX-458 as a novel therapeutic
option.”
About the Phase 2 Study
The 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 100
patients with mild cognitive impairment or mild dementia associated
with Parkinson’s disease or prodromal or manifest dementia with
Lewy bodies. The study will evaluate daily oral dosing of NYX-458
30 mg compared to placebo over a 12-week period. The study will
evaluate the overall safety and tolerability of NYX-458 in patients
and the potential cognitive benefits of NYX-458 will be evaluated
across multiple neurocognitive endpoints focused on attention,
memory, and executive function. Aptinyx anticipates reporting data
from this study in the second half of 2022. More information about
this study can be found on clinicaltrials.gov (NCT04148391).
About Cognitive Impairment Associated with Parkinson’s
Disease and Dementia with Lewy Bodies
Cognitive impairment associated with Parkinson’s disease and
dementia with Lewy bodies is characterized by a broad range of
deficits related to attention, memory, and executive function. A
common disease pathology—elevated levels of alpha synuclein—is
implicated in these conditions. Alpha synuclein has been shown to
contribute to a decrease in NMDA receptor expression and activity,
leading to a decline in cognitive and functional abilities. It is
estimated that approximately 1.4 million people in the United
States suffer from cognitive impairment due to Parkinson’s disease
or dementia with Lewy Bodies, which together account for 15-25% of
newly diagnosed dementia patients. Current treatment options for
cognitive impairment associated with Parkinson’s disease and
dementia with Lewy bodies are limited, with only one approved
treatment for PDD and no treatments approved for DLB.
About NYX-458
NYX-458 is a novel oral NMDA receptor modulator currently in
clinical development for the treatment of cognitive impairment
associated with Parkinson’s disease and dementia with Lewy bodies.
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 Aptinyx
Aptinyx 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. 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 Statements
Statements 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 and potential therapeutic effects of
NYX-458, expectations regarding the design, implementation, timing,
and success of its Phase 2 study of NYX-458 in patients with
cognitive impairment associated with Parkinson’s disease and
dementia with Lewy bodies, including with respect to COVID-19
precautionary measures, and the timing for the company’s receipt
and announcement of enrollment status and data from its Phase 2
study of NYX-458 in patients with cognitive impairment associated
with Parkinson’s disease and dementia with Lewy bodies. Risks that
contribute to the uncertain nature of the forward-looking
statements include: the effect of COVID-19 on our business and
financial results, including with respect to disruptions to our
clinical studies, business operations, and ability to raise
additional capital; 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; that
positive results from a clinical study may not necessarily be
predictive of the results of future or ongoing clinical studies;
regulatory developments in the United States and foreign countries;
the company’s estimates regarding expenses, future revenue, and
capital requirements; as well as those risks and uncertainties set
forth in the company’s most recent annual report on Form 10-K and
subsequent filings with the 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.
Source: Aptinyx Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20210406005198/en/
Investor & Media Contact: Nick Smith Aptinyx Inc.
ir@aptinyx.com or corporate@aptinyx.com 847-871-0377
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