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 two Phase 2 studies evaluating NYX-2925 for the treatment of
painful diabetic peripheral neuropathy (DPN) and for the treatment
of fibromyalgia. NYX-2925 is a novel NMDA receptor modulator that
has been granted Fast Track designation by the U.S. Food and Drug
Administration. The company expects to report data from the painful
DPN study in late 2020 or early 2021, and from the fibromyalgia
study in the first half of 2021.
“Patients suffering from painful DPN and fibromyalgia have
limited therapeutic options, which have inconsistent safety and
efficacy,” said Lesley Arnold, M.D., professor of psychiatry and
behavioral neuroscience at the University of Cincinnati and an
investigator in the fibromyalgia study. “The data from the two
prior Phase 2 studies with NYX-2925 are very compelling and I am
excited to be working with Aptinyx on these next studies as they
seek to advance this novel mechanism for chronic pain
patients.”
“These study initiations represent an important milestone
in the development of NYX-2925 for chronic centralized pain
conditions,” said Norbert Riedel, Ph.D., president and chief
executive officer of Aptinyx. “We are eager to advance NYX-2925 in
development as a novel, non-opioid therapeutic option for patients
who are vastly underserved by the treatments available today. Our
prior clinical data on NYX-2925 give us great confidence in its
potential to fill a substantial void in the treatment
paradigm.”
The company will discuss these studies during its planned live
conference call today at 5:00 p.m. EST. To access the live
conference call, please dial 1-866-930-5579 (domestic) or
1-409-216-0606 (international) and refer to conference ID 4280058.
A live audio webcast of the event will be available on the
Investors & Media section of Aptinyx’s website
at https://ir.aptinyx.com. A replay of the webcast will be
archived on Aptinyx’s website for 30 days following the event.
About the Phase 2 Painful DPN StudyThe Phase 2
study is a randomized, double-blind, placebo-controlled study
designed to evaluate the efficacy and safety of NYX-2925 in
patients with advanced DPN. Approximately 200 patients will be
enrolled in the study. Following a screening period, eligible
patients will be randomized to receive oral doses of NYX-2925 50 mg
or placebo once daily over the treatment period. The primary
endpoint in the study is the change from baseline in average daily
pain score over a 12-week period as reported on the 10-point
numeric rating scale (NRS). Multiple secondary endpoints related to
pain and patient quality of life will also be evaluated. Aptinyx
anticipates reporting top-line data from this study in late 2020 or
early 2021.
About the Phase 2 Fibromyalgia StudyThe Phase 2
study is a randomized, double-blind, placebo-controlled study
designed to evaluate the efficacy and safety of NYX-2925 in
patients with fibromyalgia. Approximately 300 patients will be
enrolled in the study. Following a screening period, eligible
patients will be randomized to receive oral doses of NYX-2925 50
mg, NYX-2925 100 mg, or placebo once daily over the treatment
period. The primary endpoint in the study is the change from
baseline in average daily pain score over a 12-week period as
reported on the 10-point numeric rating scale (NRS). Multiple
secondary endpoints related to pain, fatigue, cognitive
performance, and patient quality of life will also be evaluated.
Aptinyx anticipates reporting top-line data from this study in the
first half of 2021.
About Neuropathic Pain and Painful Diabetic Peripheral
NeuropathyNeuropathic pain, associated with various
conditions, affects an estimated 7% to 9% of the U.S. population.
Individuals suffering from this condition, regardless of the
underlying disorder, are currently treated with a variety of
therapies including antidepressants, anticonvulsants, and opioids.
These medications offer inadequate efficacy for a large proportion
of patients, are often poorly tolerated due to side effects, and in
some cases are associated with abuse.
Painful DPN is one of the largest neuropathic pain conditions.
An estimated 5 million people in the United States suffer from this
condition, which develops in 60% to 70% of people with diabetes
when chronically high glucose levels damage nerves and impair
transmission of information between the central nervous system and
other parts of the body. Patients suffering from DPN may also
experience sensory loss, leading to difficulties with balance,
coordination, and walking.
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. In Phase 1 and Phase 2 clinical studies,
NYX-2925 has exhibited a favorable safety and tolerability profile
across a wide dose range. 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, 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 through 2020; 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,
2019. 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 and Media Contact:Nick SmithAptinyx
Inc.ir@aptinyx.com or corporate@aptinyx.com847-871-0377
Source: Aptinyx Inc.
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