NIH HEAL Initiative grant, administered by
NIDA, funds preclinical and clinical studies of NYX-783 in opioid
use disorder
Preclinical studies demonstrate NYX-783 has
promising activity and safety profile relevant to treatment of
opioid use disorder, clearing path for funding and initiation of
clinical evaluation
Phase 1 clinical study in individuals using
opioids expected to begin later this year
Aptinyx Inc. (Nasdaq: APTX), a clinical-stage biopharmaceutical
company developing transformative therapies for the treatment of
nervous system disorders, today announced the finalization of a
$5.6 million grant under the National Institutes of Health (NIH)
Helping to End Addiction Long-term (HEAL) Initiative, supporting
the development of NYX-783 for the treatment of opioid use disorder
(OUD). NYX-783 is an NMDA receptor positive allosteric modulator
also in Phase 2b development by Aptinyx for the treatment of
post-traumatic stress disorder (PTSD).
The research and development of NYX-783 in OUD is funded by the
NIH HEAL Initiative grant, administered by the National Institute
on Drug Abuse (NIDA), and awarded to researchers at Yale University
School of Medicine. A Phase 1 clinical study of NYX-783 in
individuals using opioids will be conducted by researchers at Yale
and is expected to commence later this year.
“We are excited to be partnering with world-class researchers at
Yale in this evaluation of NYX-783, funded by a prestigious and
generous grant from NIDA through the NIH HEAL Initiative,” said
Andy Kidd, M.D., president and chief executive officer at Aptinyx.
“In preclinical studies to date, Aptinyx has shown that NYX-783 has
promising extinction learning activity in multiple models of
psychiatric disorders, including PTSD and alcohol use disorder.
Additional preclinical research has demonstrated NYX-783’s
potential as a treatment option for the millions of people
struggling with opioid use disorder. We look forward to
collaborating with our research partners at Yale on the initiation
of a Phase 1 clinical study of NYX-783 in people who use opioids.
The NIDA grant, secured by the experienced researchers at Yale,
ensures this development program can be advanced in a manner that
is capital efficient for Aptinyx.”
The co-principal investigators for the evaluation of NYX-783 in
OUD are Ralph DiLeone, Ph.D., professor of psychiatry and of
neuroscience at Yale University School of Medicine, and Rajita
Sinha, Ph.D., Foundations Fund endowed professor of psychiatry and
of neuroscience and child study at Yale University School of
Medicine. Under a research collaboration with Aptinyx, Dr.
DiLeone’s lab conducted preclinical studies testing NYX-783 in
animal models of OUD. In these studies, NYX-783 showed positive
effects in reducing oxycodone consumption and oxycodone-seeking
behavior. The studies also demonstrated that NYX-783 has a strong
and relevant safety profile (e.g., no respiratory depression when
administered in combination with an opiate).
“We are pleased to continue our collaboration with Aptinyx for
the evaluation of NYX-783 for the treatment of OUD,” said Dr.
DiLeone. “The data generated from our preclinical studies in models
of OUD have laid a strong foundation for the potential of NYX-783
in promoting relapse prevention among patients with opioid use
disorder. With the support of the NIDA grant, we look forward to
translating these findings to clinical benefit in humans through
this Phase 1 development program.”
The Phase 1 study will be a randomized, double-blind,
placebo-controlled study to assess the safety, tolerability, and
pharmacokinetics of NYX-783 50 mg and 150 mg, in combination with
oxycodone 15 mg and 30 mg, in individuals who use opioids. The
primary outcome measures in the study will evaluate a variety of
safety-related measures, including change in respiratory rate,
oxygenation saturation, blood pressure, heart rate, and cardiac
activity over three weeks. Secondary outcome measures will evaluate
opiate withdrawal and symptom scales over three weeks. The study
will be conducted at the Yale Interdisciplinary Stress Center
through a research collaboration with Aptinyx.
“NYX-783 presents a compelling therapeutic approach to improving
relapse prevention in patients with opioid use disorder,” said Dr.
Sinha, director of the Yale Interdisciplinary Stress Center.
“Patients suffering from OUD experience emotional dysregulation
that leads to harmful addictive behavior. NMDA receptor modulation
has demonstrated an ability to affect synaptic plasticity and
learning processes, both of which have been implicated in opiate
addiction and the vulnerability to relapse. We look forward to
moving this program into Phase 1 clinical development.”
About Opioid Use Disorder
Opioid use disorder (OUD) is a chronic brain disease in which
people continue to use opioids despite harms caused by their use.
OUD affects nearly three million people in the United States and
over 80,000 people died from overdoses involving opioids in 2021.
Over-prescription of opioid pain killers, insufficient drug
prescription controls, a rise in illicit heroin use, and the
emergence of potent synthetic forms (e.g., fentanyl) have all
contributed to the continuation of the opioid crisis and related
overdose epidemic. While medication-assisted therapies for opioid
users (e.g., methadone, buprenorphine, and naltrexone) are
available, many with OUD remain treatment refractory and vulnerable
to recurrent cycles of relapse and drug use.
About NYX-783
NYX-783 is a novel, oral, positive allosteric modulator of NMDA
receptors in Phase 2b development for the treatment of
post-traumatic stress disorder (PTSD) and in Phase 1 development
for the treatment of opioid use disorder (OUD). In preclinical
studies of NYX-783, particularly strong results were observed in
models of psychiatric disorders, fear extinction, and substance use
disorders. 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
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. Evaluation of NYX-783 for the treatment of OUD is being
conducted by researchers at Yale University School of Medicine and
funded by a $5.6 million grant under the National Institutes of
Health (NIH) Helping to End Addiction Long-term (HEAL)
Initiative.
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 multiple product candidates in
clinical development in central nervous system indications,
including cognitive impairment, post-traumatic stress disorder, and
opioid use disorder. 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 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/20221103005493/en/
Investor and Media Contact: Patrick Flavin Aptinyx Inc.
ir@aptinyx.com or corporate@aptinyx.com 847-871-0377
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