Aptinyx Reports Results from Phase 2 Study of NYX-458 in Cognitive Impairment Associated with Parkinson's Disease and Dementia with Lewy Bodies and Provides Pipeline and Corporate Update
27 Febbraio 2023 - 10:03PM
Business Wire
NYX-458 did not demonstrate sufficient efficacy
in the Phase 2 study to support further development by Aptinyx
The company will undertake cost-cutting
measures and explore strategic alternatives
The company will terminate its ongoing study of
NYX-783 in PTSD and analyze the data available to date
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 2 clinical study evaluating the effects of NYX-458 in
patients with cognitive impairment associated with Parkinson’s
disease and dementia with Lewy bodies. Across the overall study
population, NYX-458 did not demonstrate clinically meaningful
improvements over placebo on the study’s efficacy endpoints. The
results do not support further development of NYX-458 by the
company.
“We are very disappointed that the results of this Phase 2 study
did not validate the therapeutic potential observed previously in
preclinical studies of NYX-458 in models of cognitive impairment,”
said Andy Kidd, M.D., president and chief executive officer of
Aptinyx. “We appreciate the dedication and contributions of
patients, investigators, and the extensive team that worked on the
study. We intend to focus our efforts on maximizing the value of
our assets, closing our study of NYX-783 in PTSD to enable an early
analysis of the data, and exploring strategic alternatives to
support the advancement of our NMDA receptor modulation
platform.”
The first-in-patient Phase 2 study was a randomized,
double-blind, parallel-design, placebo-controlled study in 99
patients with mild cognitive impairment or mild dementia associated
with Parkinson’s disease or Dementia with Lewy Bodies. The study
evaluated daily oral dosing of a 30 mg dose level of NYX-458
compared to placebo over a 12-week period. Across the overall study
population, NYX-458 did not demonstrate clinically meaningful
improvements over placebo on the study’s efficacy endpoints. These
endpoints evaluated everyday function using the Penn Parkinson’s
Daily Activities Questionnaire (PDAQ-15) and the Everyday
Cognition-12 Scale (ECog-12), as well as cognitive performance
using a battery of computerized neurocognitive tests. NYX-458 was
well-tolerated in the study. The results overall do not support
further advancement of the development program by Aptinyx.
The company intends to undertake cost-cutting measures to
preserve capital and support the exploration of strategic
alternatives. Consistent with these measures, the company will
terminate its ongoing Phase 2b study of NYX-783 in post-traumatic
stress disorder (PTSD) and analyze the data to date to inform the
next steps for the program.
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’s proprietary
chemistry platform has generated and continues to yield a rich and
diverse array of small-molecule NMDA receptor modulators with the
potential to treat various 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,
plans to explore strategic alternatives, the therapeutic potential
of the discovery platform, and implementation of cost cutting
measures. Risks that contribute to the uncertain nature of the
forward-looking statements include: the company’s ability to
execute on its strategy; the company’s estimates regarding
expenses, future revenue, and capital requirements; risks
associated with volatility and uncertainty in the capital markets
for biotechnology companies; whether we will be able to pursue a
strategic transaction, or whether any transaction, if pursued, will
be completed; 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 and most recently filed periodic
reports. 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/20230227005764/en/
Investor & Media Contact: Patrick Flavin Aptinyx Inc.
ir@aptinyx.com or corporate@aptinyx.com 847-871-0377
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