Aptinyx Recommences Patient Recruitment in Phase 2 Study of NYX-2925 in Patients with Fibromyalgia
September 28 2020 - 8:27AM
Business Wire
Resuming study following suspension of
enrollment due to escalation of COVID-19 pandemic
Data readout expected in 1H 2022
Also on track to recommence separate Phase 2
study of NYX-2925 in painful DPN in 4Q 2020
Aptinyx Inc. (Nasdaq: APTX), a clinical-stage biopharmaceutical
company developing transformative therapies for the treatment of
brain and nervous system disorders, today announced that it has
re-activated study sites and recommenced patient recruitment in a
Phase 2 study of NYX-2925 in patients with fibromyalgia. Enrollment
in the study had been suspended in March 2020 due to the escalation
of the COVID-19 pandemic in the United States.
“We are very pleased to be restarting this study,” said Norbert
Riedel, Ph.D., president and chief executive officer of Aptinyx.
“It will build on the positive results from our first Phase 2
evaluation of NYX-2925 in patients with fibromyalgia. In support of
this recommencement, we have incorporated appropriate precautionary
measures designed to conduct this follow-up study safely in the
current COVID-19 environment. We will be watching the pace of
enrollment closely in the coming months to inform timeline
expectations, but currently expect to report data from this study
in the first half of 2022.”
About the Phase 2 Fibromyalgia Study
The 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 2022. More information about this study can be found
on clinicaltrials.gov (NCT04147858).
About Fibromyalgia
Fibromyalgia 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-2925
NYX-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 demonstrated 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 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 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 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 NYX-2925 and potential therapeutic effects of
NYX-2925, expectations regarding the design, implementation,
timing, and success of its Phase 2 study of NYX-2925 in patients
with fibromyalgia, including with respect to COVID-19 precautionary
measures, and the timing for the company’s receipt and announcement
of enrollment status and data from its Phase 2 study of NYX-2925 in
patients with fibromyalgia. Risks that contribute to the uncertain
nature of the forward-looking statements include: the effect of
COVID-19 on our business and financial results, including with
respect to disruptions to our clinical studies, business
operations, and ability to raise additional capital; 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; that 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; 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. 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/20200928005184/en/
Investor & Media Contact: Nick Smith Aptinyx Inc.
ir@aptinyx.com or corporate@aptinyx.com 847-871-0377
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