Aptinyx Presents Data Demonstrating Positive Activity of NYX-458 on Cognitive Performance and Biomarkers in a Preclinical Mod...
August 21 2019 - 8:33AM
Aptinyx Inc. (Nasdaq: APTX), a clinical-stage biopharmaceutical
company developing transformative therapies for the treatment of
brain and nervous system disorders, today announced the
presentation of preclinical data on its novel NMDA receptor
modulator, NYX-458. The product candidate demonstrated positive
recovery of performance on affective and spatial learning tasks
that was impaired in a preclinical model of repeat closed head
injury. In biomarker readings, NYX-458 also restored neuroendocrine
function following disruption due to repeat closed head injury.
These data will be exhibited in a poster presentation today at the
2019 Military Health System Research Symposium (MHSRS) in
Kissimmee, Florida.
“Traumatic brain injury often results in cognitive impairment
and mood disturbances that have a significant impact on a person’s
daily living and, unfortunately, there are very few treatment
options available today to address these long-term effects
adequately,” said Cassia Cearley, Ph.D., vice president of research
at Aptinyx. “Building upon what we already know about NYX-458’s
reversal of cognitive deficits in a non-human primate model of
cognitive impairment in Parkinson’s disease, we are very encouraged
by the strength of the data being presented at MHSRS in a model of
head injury. These data exhibit the robust activity of NYX-458 on
both cognitive performance and validated biomarkers of traumatic
brain injury. The results augment the scientific foundation
supporting our development of this product candidate for the
treatment of cognitive impairment arising from a number of
underlying conditions.”
The presented studies evaluated the effects of NYX-458 in a
repeat closed head injury preclinical model. The cognitive and
emotional deficits observed in the model are reflective of those
observed in humans that have experienced repeated traumatic brain
injury. In addition to evaluating behavioral effects, this model
enables the evaluation of biomarkers, including protein and hormone
changes, also associated with head injury.
Cognitive Performance Observations:
To evaluate the behavioral effects of NYX-458, two different
models were used to observe performance on both spatial and
affective learning tasks in rodents. In both models, Y-Maze and
Positive Emotional Learning, performance was significantly impaired
following repeat closed head injury. Administration of NYX-458
resulted in performance on both of these cognitive tasks that was
statistically significantly better than performance following
administration of vehicle.
Biomarker Observations:
The presented data show that repeat closed head injury resulted
in activation of glial fibrillary acidic proteins (GFAP); mirroring
data found in other traumatic brain injury models. Closed head
injury also resulted in transient decreases in GluN2A and GluN2B
subunits of the NMDA receptor. NYX-458, which has been shown
preclinically to positively modulate NMDA receptors, may be well
suited to address this observed NMDA receptor hypofunction,
warranting further preclinical and clinical evaluation.
Neuroendocrine changes, including reduced growth hormone and
increased corticosterone levels, were also observed following
repeat closed head injury. In the model presented, NYX-458
administration restored normal levels of corticosterone and growth
hormone.
Overall, the presented cognitive behavioral and biomarker data
further support the evaluation of NYX-458 in human clinical studies
in cognitive impairment. The results indicate the potential utility
of NYX-458 in addressing both the cognitive impairment and the
underlying disease processes associated with repeated traumatic
brain injury and other neurodegenerative conditions.
Poster Presentation Details:
Presentation Title: A Novel NMDA Receptor
Modulator, NYX-458, Shows Therapeutic Potential for Cognitive
Impairment Associated with TBI in Rats (Poster Number:
498)Authors: Katherine Leaderbrand, Luisa P
Cacheaux, Rebecca J Wilson, Mary E Schmidt, Srishti U Sahu, Tegh S.
Matharu, Crystle J. Kelly, Angela M. Lynch, Jeffrey S Burgdorf,
Cassia Cearley, Joseph R MoskalPresenter:
Katherine Leaderbrand, Ph.D., AptinyxPoster
Presentation: August 21th, 2019
About NYX-458NYX-458 is a novel oral NMDA
receptor modulator currently in clinical development for the
treatment of cognitive impairment associated with Parkinson’s
disease. NYX-458 has been shown to reverse cognitive deficits in
non-human primates in a model that is highly translatable to
Parkinson’s disease in humans. Additionally, NYX-458 has been shown
to improve cognitive performance across various models of
neurodegeneration. In a Phase 1 clinical study, NYX-458 exhibited a
favorable safety and tolerability profile across a wide dose range
and achieved CNS exposure in line with exposure observed with
efficacious preclinical dose levels.
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, 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; 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.
Investor & Media Contact:Nick SmithAptinyx
Inc.ir@aptinyx.com or corporate@aptinyx.com847-871-0377
Source: Aptinyx Inc.
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