Aptinyx Reports Results from Phase 2b Study of NYX-2925 in Fibromyalgia
August 12 2022 - 6:15AM
Business Wire
NYX-2925 did not achieve the primary endpoint
of the study
Aptinyx Inc. (Nasdaq: APTX), a clinical-stage biopharmaceutical
company developing transformative therapies for the treatment of
brain and nervous system disorders, today announced results from a
Phase 2b clinical study evaluating the effects of NYX-2925 in
patients with fibromyalgia. NYX-2925 did not achieve statistically
significant separation from placebo on the study’s primary
endpoint, which assessed the change from baseline in average daily
pain on the numeric rating scale (NRS) during week 12.
“We are very disappointed that, despite the evidence of activity
observed in a prior biomarker study in fibromyalgia patients, in
this follow-up Phase 2b study NYX-2925 did not achieve statistical
separation from placebo,” said Andy Kidd, M.D., president and chief
executive officer of Aptinyx. “We greatly appreciate the
contributions made by patients, investigators, collaborators, and
our dedicated Aptinyx team in the evaluation of NYX-2925’s utility
in pain. The results of this study highlight the challenges of
developing novel therapies for pain. As we continue to analyze the
data from the study, we will focus our resources on supporting
additional readouts from our pipeline in PTSD and cognitive
impairment, including the readout of our Phase 2 study of NYX-458
in cognitive impairment associated with Parkinson’s disease,
expected in the first quarter of next year.”
The Phase 2b fibromyalgia study was a randomized, double-blind,
placebo-controlled study designed to evaluate the efficacy and
safety of NYX-2925 in approximately 300 patients with fibromyalgia.
Following a screening period, eligible patients were 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 was the change from baseline in average daily pain as
reported on the zero-to-ten NRS during week 12 of the study.
Statistically significant separation from placebo was not
observed on the primary endpoint of the study with either dose
level of NYX-2925. Patients receiving NYX-2925 at both dose levels
showed a trend toward clinically meaningful improvement in pain, as
well as in some secondary endpoints, versus placebo by week 4.
However, by week 12, the placebo group had improved such that,
although NYX-2925 remained numerically better, the separation was
not clinically meaningful. Across both dose levels, NYX-2925 was
well tolerated in the study, with no concerning safety issues
observed. Detailed data from the study continue to be
evaluated.
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. 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, therapeutic effects of the company’s
product candidates and discovery platform, expectations regarding
the design, implementation, timing, and success of its current and
planned clinical studies, and the timing for the company’s receipt
and announcement of data from its clinical studies. Risks that
contribute to the uncertain nature of the forward-looking
statements include: the effect of the COVID-19 pandemic on our
business and financial results, including with respect to
disruptions to our clinical trials, 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; positive results from a clinical study may not
necessarily be predictive of the results of future or ongoing
clinical studies; regulatory approval processes of the FDA and
comparable foreign regulatory authorities are lengthy,
time‑consuming, and inherently unpredictable; regulatory
developments in the United States and foreign countries; the
company’s estimates regarding expenses, future revenue, and capital
requirements; the company’s ability to fund operations into 2024;
as well as those risks and uncertainties set forth in the company’s
most recent periodic filings with the Securities and Exchange
Commission, including our Annual Report on Form 10-K for the year
ended December 31, 2021. 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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Investor & Media Contact: Patrick Flavin Aptinyx Inc.
ir@aptinyx.com or corporate@aptinyx.com 847-871-0377
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