Aptinyx Completes Enrollment in Phase 2 Study of NYX-458 in Cognitive Impairment Associated with Parkinson’s Disease and Dementia with Lewy Bodies
25 Agosto 2022 - 1:30PM
Business Wire
Results from the Phase 2 study are expected in
1Q 2023
Aptinyx Inc. (Nasdaq: APTX), a clinical-stage biopharmaceutical
company developing transformative therapies for the treatment of
brain and nervous system disorders, today announced the completion
of enrollment of 99 patients in the company’s ongoing Phase 2 study
of NYX-458 in cognitive impairment associated with Parkinson’s
disease and dementia with Lewy bodies. Patients recently enrolled
in the study are completing the 12-week treatment period and 30-day
safety follow-up period. The company expects to report results from
the study in 1Q 2023.
"The completion of enrollment in our Phase 2 study of NYX-458 is
a significant milestone for Aptinyx,” said Andy Kidd, M.D.,
president and chief executive officer of Aptinyx. “The study is
well-designed to characterize the effects of NYX-458 on established
measures of attention, memory, and executive function—areas in
which many patients with Parkinson’s disease and dementia with Lewy
bodies experience challenging deficits. As a positive allosteric
modulator of NMDA receptors, NYX-458 has the potential to directly
address the NMDA receptor hypofunction that underpins cognitive
impairment in these patients. We look forward to completing the
study and announcing results in the first quarter of next
year."
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 99 patients with
mild cognitive impairment or mild dementia associated with
Parkinson’s disease or dementia with Lewy bodies. The study
evaluates daily oral dosing of a 30 mg dose level of NYX-458
compared to placebo over a 12-week period. The study assesses the
overall safety and tolerability of NYX-458 in patients, as well as
its effects across multiple neurocognitive endpoints focused on
attention, memory, and executive function. 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 Parkinson’s disease dementia and no treatments
approved for dementia with Lewy bodies.
About NYX-458
NYX-458 is a novel oral NMDA receptor positive allosteric
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
fibromyalgia, 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 or follow Aptinyx on
Twitter @Aptinyx.
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 the company’s current and potential clinical studies
of NYX-458, and the timing for the company’s receipt and
announcement of data from its Phase 2 study of NYX-458. 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 trials, 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; 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/20220825005244/en/
Investor & Media Contact: Patrick Flavin Aptinyx Inc.
ir@aptinyx.com or corporate@aptinyx.com 847-871-0377
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