Aptinyx Initiates Phase 2b Study of NYX-783 in Patients with Post-Traumatic Stress Disorder
16 December 2021 - 11:37PM
Business Wire
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 2b study evaluating 50 mg QD of NYX-783 in 300 patients
with post-traumatic stress disorder (PTSD). The Phase 2b study is
designed to be well-positioned for consideration as
registration-supportive, taking into account guidance received in a
Type C meeting with the U.S. Food and Drug Administration (FDA)
earlier this year. Initiation of this study follows the observation
of clinically meaningful symptom improvements in a previously
completed exploratory Phase 2a study of NYX-783 in PTSD. The
company anticipates reporting data from the Phase 2b study in the
second half of 2023.
“New therapeutic approaches are urgently needed for the millions
of people living with PTSD,” said Chadi Abdallah, M.D., Associate
Professor and Beth K. and Stuart C. Yudofsky Chair in the
Neuropsychiatry of Military Post-Traumatic Stress Syndrome at
Baylor College of Medicine. “The safety profile and encouraging
efficacy signals observed in prior clinical studies of NYX-783
highlight its therapeutic potential and suggest NMDA receptor
modulation may represent a promising and innovative mechanism for
the treatment of this devastating neuropsychiatric disorder.”
“Today’s study initiation is an important step forward on the
path to establishing NYX-783 as a novel treatment option for
patients with PTSD,” said Norbert Riedel, Ph.D., chief executive
officer of Aptinyx. “This is the first of two well-controlled Phase
2b studies that will evaluate different dose levels of NYX-783. The
level of unmet need surrounding PTSD and mental health has never
been more prevalent than it is today, and we are excited to be
advancing NYX-783 into late-stage development for a disease area
that has not seen a new therapy approved in over 20 years.”
About the NYX-783 Phase 2b PTSD Program The NYX-783 Phase 2b
PTSD program will consist of two separate studies to evaluate
NYX-783 at two dose levels: 50 mg and 150 mg. The studies will be
multi-center, placebo-controlled, double-blind, randomized,
parallel design studies in patients with moderate to severe PTSD,
as characterized by criteria set forth in the Diagnostic and
Statistical Manual of Mental Disorders, 5th Edition (DSM-5). The
primary efficacy endpoint of each study will be the change from
baseline in the Clinician-Administered PTSD Scale for the DSM-5
(CAPS-5) Total score. Key secondary endpoints in both studies will
include various measures of global impression of severity and
improvement (CGI-S, CGI-I, PGI-S, PGI-I).
In the first Phase 2b study, approximately 300 patients will be
randomized to receive either placebo or 50 mg of NYX-783
administered orally once daily. The study will comprise a 1- to
4-week screening period, a 10-week treatment period, and a
follow-up evaluation period. Following the initiation of the 50 mg
study, a second Phase 2b study will commence in which approximately
300 patients will be randomized to receive either placebo or 150 mg
of NYX-783 administered orally once daily. The other design
parameters of the 150 mg study will be consistent with those of the
50 mg study.
About Post-Traumatic Stress Disorder Approximately fifteen
million adults in the United States suffer from PTSD in a given
year, 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 in treating
PTSD, 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, positive allosteric
modulator of NMDA receptors 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 adverse event and tolerability
profile, with no serious adverse effects, across a wide dose range.
In an exploratory Phase 2a study in patients with PTSD, patients
receiving a 50 mg dose level of NYX-783 showed meaningful symptom
improvements and rates of response. The U.S. Food and Drug
Administration has granted Fast Track designation to the
development of NYX-783 for the treatment of PTSD.
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
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 the company’s product
candidates, therapeutic effects of the company’s product
candidates, expectations regarding the design, implementation,
timing, and success of its current and planned clinical studies,
the timing for the company’s receipt of data from its clinical
studies, 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; 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, and other financial
results; the company’s ability to fund operations; 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, including our upcoming
quarterly report on Form 10-Q for the period ended September 30,
2021. 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/20211216005331/en/
Investor and Media Contact: Patrick Flavin Aptinyx Inc.
ir@aptinyx.com or corporate@aptinyx.com 847-871-0377
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