Aptinyx Completes Enrollment in Phase 2 Exploratory Study of NYX-783 in Post-Traumatic Stress Disorder
June 18 2020 - 7:57AM
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 in its ongoing Phase 2 exploratory study of NYX-783
to evaluate the safety and efficacy of NYX-783 in patients with
post-traumatic stress disorder (PTSD). The company anticipates
reporting data from the study in late 2020.
“The completion of enrollment in our Phase 2 exploratory study
of PTSD represents an important clinical development milestone for
our company,” said Norbert Riedel, Ph.D., president and chief
executive officer of Aptinyx. “We sincerely thank the patients for
participating in this study and the hard-working professionals at
the sites for their willingness to persist despite the challenges
introduced by the COVID-19 pandemic. We look forward to completing
this study in the coming months and evaluating the data to
determine the most appropriate next steps in development to address
the unmet need in PTSD.”
About the Phase 2 Exploratory Study The Phase 2
exploratory study (NCT04044664) is a multi-center,
placebo-controlled, double-blind, randomized, Sequential Parallel
Comparison Design study in patients with PTSD, as characterized by
criteria set forth in the Diagnostic and Statistical Manual of
Mental Disorders, 5th Edition (DSM-5). In the study, 160 patients
were randomized into one of three treatment arms: placebo, NYX-783
10 mg, or NYX-783 50 mg administered orally once-daily. The Phase 2
study duration is ten to thirteen weeks overall, consisting of a
screening period, two treatment periods, and a safety follow-up
period. During the study, patients randomized to receive NYX-783
will receive it over four consecutive weeks.
The primary efficacy endpoint of the study is the change in
CAPS-5 (Clinician-Administered PTSD Scale for the DSM-5) total
score and sub-scores from baseline to the end of each of the
four-week treatment periods. The CAPS-5 is a standardized
structured clinical interview for measuring and diagnosing symptom
severity and frequency in PTSD patients. Additional endpoints
evaluate the safety and tolerability of NYX-783 and the potential
benefits of NYX-783 on various PTSD symptoms, including sleep
quality, cognitive function, anxiety, and depression in PTSD
patients. The data from this first-in-patient, exploratory, Phase 2
study are expected to inform future development plans for NYX-783
in PTSD.
About Post-Traumatic Stress
DisorderApproximately eight and a half million people in
the United States suffer from PTSD, which is characterized by
intrusive symptoms, avoidance, negative alteration in cognition and
mood, hyperarousal, and/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 seven 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 NYX-783 NYX-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 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-783 and
potential therapeutic effects of NYX-783, expectations regarding
the design, implementation, timing, and success of its current and
potential clinical studies of NYX-783, the timing for the company’s
receipt and announcement of data from its exploratory study of
NYX-783, and expectations regarding its preclinical development
activities. 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; 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.
Investor & Media Contact:Nick SmithAptinyx
Inc.ir@aptinyx.com or corporate@aptinyx.com847-871-0377
Source: Aptinyx Inc.
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