Aptinyx Announces Results of Phase 2 Fibromyalgia Study of NYX-2925 Have Been Selected for Late-Breaking Presentation at the ...
October 28 2019 - 6:57AM
Aptinyx Inc. (NASDAQ: APTX), a clinical-stage biopharmaceutical
company developing transformative therapies for the treatment of
brain and nervous system disorders, today announced that the
results of a Phase 2 study of NYX-2925 in patients with
fibromyalgia have been selected for a late-breaking poster
presentation at the American College of Rheumatology Annual
Meeting. The study was conducted in collaboration with the Chronic
Pain and Fatigue Research Center at the University of Michigan
Medical School and the Women's Health Research Program at
University of Cincinnati College of Medicine.
“The opportunity to showcase these clinical data in a
late-breaking presentation demonstrates their scientific importance
in a field in dire need of new therapeutic options,” said Norbert
Riedel, Ph.D., president and chief executive officer of Aptinyx.
“We and our collaborators at the University of Michigan and the
University of Cincinnati are very pleased with the clinical data
yielded from this study. These data demonstrate that NYX-2925 is
affecting biomarkers known to be associated with centralized pain
processing, and that the activity of NYX-2925 resulted in
improvements on pain scores and other patient-reported symptoms.
Taken together, the imaging data and the clinical outcomes from
this study are highly supportive of the continued development of
NYX-2925 in chronic centralized pain conditions.”
In the study, patients received daily doses of placebo for two
weeks, then 20 mg of NYX-2925 daily for two weeks, followed by 200
mg of NYX-2925 daily for two weeks. During the second week of each
of the dosing periods, patients underwent neuroimaging evaluations
to assess effects on neural markers of centralized pain processing
and fibromyalgia. Throughout the study, patients also reported
their symptoms across a number of clinical measures, including
daily pain scores, fatigue, and other symptom questionnaires.
Administration of NYX-2925 resulted in statistically significant
changes on the neuroimaging markers, the primary endpoint in the
study. NYX-2925 administration also resulted in statistically
significant and clinically meaningful improvements on pain,
fatigue, and other fibromyalgia symptoms. Across all patients in
the study, NYX-2925 was safe and well tolerated with no serious
adverse events.
“The results from this study are very encouraging based on
our previous demonstration of the relevance of these neural markers
in patients with fibromyalgia,” said Steven Harte, Ph.D., Associate
Research Scientist and Director of Sensory Science, at the Chronic
Pain and Fatigue Research Center.“ We were able to objectively
measure that NYX-2925 is affecting the apparent central
manifestation of pain and other symptoms in these patients—a
significant step forward in developing new therapeutic options for
fibromyalgia. The effects observed in this study with NYX-2925,
both on neural markers and clinical measures, compare favorably to
the results we saw in prior studies conducted using approved
fibromyalgia treatments and bode well for the next study the
company is conducting.”
About FibromyalgiaFibromyalgia is a chronic
condition associated with widespread pain and tenderness, as well
as general fatigue. Fibromyalgia is considered by many to be a
condition that is largely mediated in the central nervous system,
given that fibromyalgia sufferers often present without a direct
peripheral insult or injury. People suffering from fibromyalgia
also often experience sleep disruption, depressed mood, and
cognitive impairment. It is estimated that, in the United States,
fibromyalgia affects more than 5 million people. Currently, there
are only three FDA-approved pharmacologic treatments for
fibromyalgia, but they have limited efficacy and burdensome side
effects in many patients.
About NYX-2925NYX-2925 is a novel oral NMDA
receptor modulator currently in Phase 2 clinical development for
the treatment of chronic pain. In clinical studies, NYX-2925 has
been shown to have activity that affects central pain processing,
resulting in alleviation of pain and other symptoms associated with
chronic pain conditions. NYX-2925 has also exhibited a favorable
safety and tolerability profile across a wide dose range in
preclinical and clinical studies. The U.S. Food and Drug
Administration has granted Fast Track designation to Aptinyx’s
development of NYX-2925 for the treatment of neuropathic pain
associated with DPN.
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, therapeutic effects of the company’s product
candidates, expectations regarding the design, implementation,
timing, and success of its current and planned clinical trials,
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;
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.
Investor Contacts:Nick SmithAptinyx
Inc.ir@aptinyx.com847-871-0377
Source: Aptinyx Inc.
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