Aptinyx Announces Recommencement of Phase 2 Study of NYX-2925 in Patients With Painful Diabetic Peripheral Neuropathy
January 04 2021 - 7:57AM
Business Wire
Study has resumed following suspension of
enrollment due to escalation of COVID-19 pandemic
Aptinyx now has two parallel-design,
placebo-controlled Phase 2b studies ongoing with NYX-2925 in highly
prevalent chronic pain indications
Data readouts for NYX-2925 studies in both
painful DPN and fibromyalgia expected in 1H 2022
Aptinyx Inc. (Nasdaq: APTX), a clinical-stage biopharmaceutical
company developing transformative therapies for the treatment of
brain and nervous system disorders, today announced that in
December it recommenced patient recruitment and screening in a
Phase 2 study of NYX-2925 in patients with painful diabetic
peripheral neuropathy (DPN). Enrollment in the study had been
suspended due to the escalation of the COVID-19 pandemic in the
United States.
“We are pleased to have recommenced our Phase 2 study in painful
DPN and remain committed to responsible clinical investigation
while prioritizing the safety of patients and study personnel
during the ongoing COVID-19 pandemic,” said Norbert Riedel, Ph.D.,
chief executive officer of Aptinyx. “This study in painful DPN
represents the second ongoing Phase 2 study of NYX-2925 in chronic
pain, alongside our concurrent study in fibromyalgia, and we expect
to read out data from each of these studies in the first half of
2022.”
About the Phase 2 Painful DPN 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 advanced painful 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 the first half of 2022. More information about
this study can be found on clinicaltrials.gov (NCT04146896).
About Neuropathic Pain and Painful Diabetic Peripheral
Neuropathy
Neuropathic 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 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 painful diabetic peripheral neuropathy, 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 painful
diabetic peripheral neuropathy. 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/20210104005215/en/
Investor & Media Contact: Nick Smith Aptinyx Inc.
ir@aptinyx.com or corporate@aptinyx.com 847-871-0377
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