Aptinyx Presents Additional Positive Data from Phase 2 Exploratory Study of NYX-783 in PTSD at Society of Biological Psychiat...
April 29 2021 - 6:47AM
Business Wire
Aptinyx Inc. (NASDAQ: APTX), a clinical-stage biopharmaceutical
company developing transformative therapies for the treatment of
brain and nervous system disorders, today presented additional data
from its exploratory Phase 2 study of NYX-783 in patients with
post-traumatic stress disorder (PTSD) at the Society of Biological
Psychiatry (SOBP) Annual Meeting being held virtually April 29 -
May 1, 2021.
The Phase 2 study evaluated NYX-783 in 153 patients with PTSD.
The study consisted of two four-week treatment stages comparing
once-daily oral dosing of NYX-783—10mg or 50mg—to placebo. This
initial exploratory study was powered based on clinical, and not
statistical, considerations to detect signals of efficacy.
Nonetheless, statistically significant separation from placebo
(using a one-sided p<0.1, based on the prespecified statistical
analysis plan for this exploratory study) was observed on some
measures. The prespecified combined analysis of stages 1 and 2
revealed a numerical benefit on the CAPS-5 Total score and a
statistically significant benefit on the Arousal and Reactivity
symptom cluster score for the 50 mg dose compared to placebo. The
results from stage 1, which reflect all patients enrolled in the
study, provide the greatest insights into the potential effects of
NYX-783 for future studies and, therefore, are the primary focus of
the poster being presented at SOBP.
Key highlights of stage 1 data presented at SOBP include the
following:
- A significantly greater proportion (p<0.05) of patients
achieved a Clinically Reliable Change (improvement of ≥13 points on
the CAPS-5 Total score) in the 50 mg treatment group compared to
placebo.
- Percentage improvement on the CAPS-5 Total score for the
NYX-783 50 mg group was significant (p<0.05 vs. placebo) when
adjusting for variances in patients’ time since trauma.
- NYX-783 demonstrated clinically meaningful improvements on the
CAPS-5 Total Score and symptom cluster scores with a favorable
safety and tolerability profile.
“The lack of effective pharmacotherapies in PTSD make the
results from this study important,” said Murray Stein, MD, MPH,
FRCPC, Distinguished Professor of Psychiatry and Public Health and
Vice Chair for Clinical Research in Psychiatry at the University of
California San Diego and a consultant to Aptinyx. “While there have
been numerous attempts to bring new therapies forward in PTSD, it
has proven to be a very challenging indication. These results
suggest that NYX-783, with its novel NMDA receptor modulatory
mechanism, has potential to offer meaningful symptom relief to
patients that desperately need better options.”
“The dataset presented today further illustrates the therapeutic
potential of NYX-783 for people living with post-traumatic stress
disorder,” said Norbert Riedel, Ph.D., chief executive officer of
Aptinyx. “We are pleased with the clinical effects demonstrated in
this study, including the significant separation observed on
clinically reliable change and the significant effects demonstrated
when adjusting for time since trauma. We plan to incorporate these
learnings into our next, larger study of NYX-783 in PTSD.”
An electronic version of the poster can be found on the Aptinyx
website.
Poster: “A Randomized, Placebo-Controlled, Double-Blind
Study of NYX-783 in Patients with Posttraumatic Stress Disorder,”
Lori L. Davis, Murray B. Stein, Lesley M. Arnold, Kathryn King,
Kerrin Young, Harald Murck, Rolando Gutierrez-Esteinou Poster
Number: T286 Poster Session: Thursday April 29th,
12:15pm – 1:15pm CT
- Numerical improvement was observed on the CAPS-5 Total Score
(50 mg QD group compared to placebo).
- Significantly more subjects demonstrated a Clinically Reliable
Change (improvement of ≥13 points on the CAPS-5 Total score) when
treated with NYX-783 50 mg compared to placebo, suggesting the
effect is driven by NYX-783 rather than test-retest variability or
overall variability in PTSD symptoms during the evaluation period.
- The reliable change index can be interpreted to signify
clinically meaningful treatment benefit.
- After correcting for baseline imbalances in time since trauma,
percentage improvement on the CAPS-5 Total score was significant
(p<0.05) (exploratory) [ANCOVA LSM (SE)].
- On the CAPS-5 symptom cluster scores, improvements on Arousal
and Reactivity and Negative Cognitions and Mood were significant
for the 50 mg QD group (all p<0.05).
- Improvement on the HADS-Anxiety scale was statistically
significant for the 10 and 50 mg groups.
- NYX-783 was well-tolerated compared to placebo and there were
no drug-related serious adverse events.
About Post-Traumatic Stress Disorder Approximately 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 development for the treatment of post-traumatic stress
disorder (PTSD). In an exploratory Phase 2 clinical study,
administration of NYX-783 resulted in clinically meaningful
improvements on PTSD symptoms with a favorable tolerability
profile. In preclinical studies of NYX-783, robust activity has
been observed in psychiatric models, models of fear extinction, and
models of substance abuse. In a Phase 1 clinical study of NYX-783,
functional 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. 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.
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 therapeutic effects of NYX-783 and
expectations regarding the design, implementation, timing, and
success of the company’s planned clinical trials. 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;
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 in its other filings and
reports with the United States 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/20210429005276/en/
Investor Contacts: Nick Smith Aptinyx Inc. ir@aptinyx.com
847-871-0377
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