Aptinyx Inc. (Nasdaq: APTX), a clinical-stage biopharmaceutical
company developing transformative therapies for the treatment of
brain and nervous system disorders, today announced the
presentation of preclinical data on its novel NMDA receptor
modulator, NYX-783, demonstrating that the product candidate
robustly attenuated alcohol-seeking and relapse-like behavior in
multiple models of alcohol use disorder. These studies were
conducted in collaboration with the Medical University of South
Carolina and data are being exhibited in a poster presentation
today at the 42nd Annual Research Society on Alcoholism Scientific
Meeting in Minneapolis, Minnesota.
“Given the increasingly recognized societal impact of substance
abuse, and the lack of safe and effective therapies, we are very
encouraged by the activity demonstrated by NYX-783 in these
preclinical models of alcohol use disorder,” said Cassia Cearley,
Ph.D., vice president of research at Aptinyx. “Together with the
favorable safety and tolerability profile already demonstrated in a
Phase 1 study, these data strongly support the development of
NYX-783 in substance abuse conditions. With NYX-783 currently in
Phase 2 development as a therapy for PTSD, the results from these
preclinical studies support its potential to treat one of the more
prevalent comorbidities associated with PTSD, and expand the
potential indications in which the mechanism of NYX-783 may have
relevance.”
In the studies being presented, behavior was assessed in two
different models of alcohol use disorder in which animals were
trained to self-administer ethanol through lever pressing. In the
first model, an alcohol dependence model, alcohol dependence was
induced in rats by exposing animals to ethanol vapor, with exposure
to air used as a comparative control. After alcohol dependence was
established, rats were dosed with either 0.1 mg/kg NYX-783, 6 mg/kg
NYX-783, or vehicle one hour prior to the first extinction session.
During the extinction sessions, animals were exposed to cues
previously associated with alcohol intake, however lever pressing
no longer resulted in alcohol delivery. Extinction was measured by
the number of days to achieve elimination of alcohol-seeking
behavior. Three weeks after extinction, rats were evaluated for
relapse-like behavior after re-exposure to alcohol associated cues.
In the second model, a stress-induced alcohol-seeking model, rats
were exposed to a stressor prior to being trained to
self-administer ethanol. Stress exposure increased alcohol-seeking
behavior and rendered rats resistant to extinction of
alcohol-seeking behavior. This approach models the influence of
PTSD on substance abuse. Animals were then evaluated during and
after the same extinction paradigm as described in the alcohol
dependence model.
In both the alcohol dependence model and the stress-induced
alcohol seeking model, animals dosed with NYX-783 prior to
extinction demonstrated a significantly more rapid elimination of
alcohol-seeking behavior as compared to vehicle (p<0.0001 for
both studies). Animals dosed with NYX-783 prior to extinction also
demonstrated significantly less relapse-like behavior when exposed
to alcohol-associated cues in the alcohol dependence model
(p<0.001) or stress-associated cues in the stress-induced
alcohol-seeking model (p<0.05). In the stress-induced alcohol
seeking model, animals that were only dosed with NYX-783 prior to
re-exposure to the stress-associated cue also demonstrated
significantly less relapse-like behavior when compared to
vehicle-treated rats (p<0.05).
The data being presented support the continued evaluation of
NYX-783 in human clinical studies and indicate that treatment with
NYX-783 may be an effective approach to addressing alcohol abuse in
patients with or without comorbid PTSD.
Poster Presentation Details:
Presentation Title: The Novel NMDAR Modulator
NYX-783 Facilitates Extinction of Ethanol-seeking Behavior and
Blocks Relapse-like Behavior Primed by Ethanol-associated Cues or
Prior Stress in Rats (Poster Number:
039-732)Authors: Cora Smiley (MUSC), Cassia
Cearley, Ph.D. (Aptinyx), Justin T. Gass, Ph.D. (MUSC), M. Scott
Bowers, Ph.D. (Aptinyx) Presenter: M. Scott
Bowers, Ph.D., AptinyxPoster Presentation: June
26th, 2019
About NYX-783NYX-783 is a novel, oral NMDA
receptor modulator currently in Phase 2 development for the
treatment of post-traumatic stress disorder (PTSD). In preclinical
studies of NYX-783, particularly strong results were observed in
psychiatric models, models of fear extinction, and models of
substance abuse. In a Phase 1 clinical study of NYX-783, ample
central nervous system exposure was observed and the product
candidate demonstrated a favorable safety and tolerability profile,
with no serious adverse effects, across a wide dose range. The U.S.
Food and Drug Administration has granted Fast Track designation to
the development of NYX-783 for the treatment of PTSD.
About Alcohol Use DisorderAlcohol use disorder
is a chronic, relapsing condition characterized by compulsive
alcohol use, loss of control over alcohol intake, and a negative
emotional state when not using alcohol. Alcohol use disorder
affects an estimated 16 million people in the United States.
Currently, there are limited treatment options available for
alcohol use disorder and the pharmacotherapies used often come with
substantial side effects.
About Post-Traumatic Stress DisorderMore than
eight million people in the United States suffer from PTSD, which
is characterized by intrusive symptoms, avoidance, negative
alteration in cognition and mood, hyperarousal, or arousal
alterations following the experience of trauma. PTSD can result
from various forms of trauma, including combat exposure, car
accidents, sexual or other physical assault, abuse, natural
disasters, and others. The lifetime prevalence of PTSD is
approximately eight percent in the general population, but is much
higher in populations at risk for exposure to trauma, such as
military service members and first responders. In addition to the
challenges associated with the direct symptoms, PTSD sufferers have
a higher rate of suicide and often struggle with simultaneous
addiction, leading to an even greater social and economic burden of
the disorder. Available therapeutic options are limited, including
only two approved conventional SSRI antidepressants, which have
limited efficacy, undesirable side effects, and target only the
symptoms of PTSD, not the underlying disorder itself.
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-2925,
therapeutic effects of the company’s product candidates,
expectations regarding the design, implementation, timing, and
success of its current and planned clinical studies, 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; 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; 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.
Investor & Media Contact:Nick SmithAptinyx
Inc.ir@aptinyx.com or corporate@aptinyx.com847-871-0377
Source: Aptinyx Inc.
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