Aptinyx Highlights Key Goals and Anticipated Development Milestones for 2022
06 January 2022 - 11:37PM
Business Wire
Catalyst-rich year with data readouts expected
from three Phase 2 studies across chronic pain and cognitive
impairment development programs
Advancing PTSD development program with
initiation of Phase 2b studies
Strong balance sheet expected to fund Phase 2
readouts from each ongoing development program
Company will host Portfolio Review Event on
February 9, 2022, with focus on development of NYX-2925 for chronic
pain
Aptinyx Inc. (Nasdaq: APTX), a clinical-stage biopharmaceutical
company developing transformative therapies for the treatment of
brain and nervous system disorders, today provided a corporate
update and highlighted development milestones anticipated in
2022.
“Following a year of extraordinary execution, Aptinyx enters
2022 positioned for transformational growth, with a robust slate of
Phase 2 study readouts fast approaching,” said Andy Kidd, M.D.,
president and chief executive officer of Aptinyx. “Our four
clinical development programs currently underway highlight the
broad potential of our pipeline of novel, rationally-designed NMDA
receptor modulators across a range of major neurological
indications. The multiple data catalysts upcoming represent key
milestones in support of our goal of establishing Aptinyx as a
leading neuroscience company and improving the lives of millions of
people living with serious nervous system disorders.”
Clinical Programs and Anticipated 2022 Milestones
NYX-2925 for chronic pain – Phase 2b readouts expected in 2Q
and mid-year 2022: NYX-2925 is a novel oral NMDA receptor
positive allosteric modulator currently in Phase 2b clinical
development for the treatment of painful DPN and fibromyalgia.
- In late October 2021, Aptinyx announced the completion of
enrollment in its Phase 2b study of NYX-2925 in 229 patients with
painful diabetic peripheral neuropathy (DPN). The company
anticipates reporting results from the study in early to mid second
quarter 2022.
- The company’s Phase 2b study of NYX-2925 in 300 patients with
fibromyalgia is on track to report results in mid 2022.
NYX-458 for cognitive impairment – Phase 2 readout
expected in 2H 2022: NYX-458 is a novel oral NMDA receptor
positive allosteric modulator currently in Phase 2 clinical
development for the treatment of cognitive impairment associated
with Parkinson’s disease and dementia with Lewy bodies.
- Enrollment is progressing in an exploratory Phase 2 study of
NYX-458 in 100 patients with cognitive impairment associated with
Parkinson’s disease and dementia with Lewy bodies. The company
anticipates reporting data from the study in the second half of
2022.
NYX-783 for PTSD – Phase 2b readout expected in 2023:
NYX-783 is a novel, oral NMDA receptor positive allosteric
modulator currently in Phase 2b clinical development for the
treatment of post-traumatic stress disorder (PTSD).
- In December 2021, Aptinyx initiated a Phase 2b study evaluating
50 mg QD of NYX-783 in 300 patients with PTSD. The company
anticipates reporting data from the study in the second half of
2023.
- A Phase 2b study evaluating a higher 150 mg QD dose level of
NYX-783 in 300 patients with PTSD is on track for initiation in the
first quarter of 2022.
Cash Position and Financial Guidance
Aptinyx ended the fourth quarter of 2021 with approximately $106
million in cash and cash equivalents (unaudited), with access to
additional capital under a growth capital credit facility with K2
HealthVentures. The company expects its current cash balance and
guaranteed available cash to fund Phase 2 readouts from each of its
ongoing development programs and support anticipated operations
into 2023.
Upcoming Q1 2022 Presentations and Discussions
- January 10, 2022 – Virtual Presentation at the H.C. Wainwright
2022 BioConnect Conference
- January 13, 2022 – Virtual presentation at the 40th Annual J.P.
Morgan Healthcare Conference
- February 9, 2022 – Aptinyx Portfolio Review Event, featuring
Dr. Richard Rauck, board certified physician in pain medicine and
anesthesiology at Carolinas Pain Institute and medical director for
The Center for Clinical Research based in Winston-Salem
- February 14-15, 2022 – Virtual fireside chat at the 11th Annual
SVB Leerink Global Healthcare Conference
- March 7-9, 2022 – Neuropysch panel discussion at the 42nd
Annual Cowen Health Care Conference
About NYX-2925
NYX-2925 is a novel oral NMDA receptor positive allosteric
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. NYX-2925 has also exhibited a favorable
safety and tolerability profile across a wide dose range in
clinical studies to date. 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 NYX-783
NYX-783 is a novel oral NMDA receptor positive allosteric
modulator currently in Phase 2 clinical development for the
treatment of post-traumatic stress disorder (PTSD). In preclinical
studies of NYX-783, therapeutically relevant enhancement of
extinction learning has been observed in models of conditioned fear
and substance abuse. In an exploratory Phase 2 clinical study,
administration of NYX-783 resulted in clinically meaningful
improvements on PTSD symptoms. NYX-783 has also exhibited a
favorable safety and tolerability profile across a wide dose range
in clinical studies to date. The U.S. Food and Drug Administration
has granted Fast Track designation to the development of NYX-783
for the treatment of PTSD.
About NYX-458
NYX-458 is a novel oral NMDA receptor positive allosteric
modulator currently in Phase 2 clinical development for the
treatment of cognitive impairment associated with Parkinson’s
disease and dementia with Lewy bodies. 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. NYX-458 has
also been shown to improve cognitive performance across various
other preclinical 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
exposures consistent with exposures observed at efficacious
preclinical dose levels.
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, expectations, and potential therapeutic effects of its
development candidates, expectations regarding the design,
implementation, timing, and success of its current and potential
clinical studies, the timing for the company’s receipt and
announcement of data, the company’s belief in the potential for
upcoming catalysts and milestones to be transformational and to
support our mission, the company’s views as to the potential
profile and benefit of our product candidates, and expectations
regarding the company’s cash runway. 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 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; delays of any current preclinical studies;
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/20220106005304/en/
Patrick Flavin Aptinyx Inc. ir@aptinyx.com or
corporate@aptinyx.com 847-871-0377
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