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Aptinyx Announces Publication of Review Article Highlighting Preclinical Data in Medicine in Drug Discovery Demonstrating the Potential of NYX-2925 to Treat Chronic, Centralized Pain Conditions

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Aptinyx Inc. (Nasdaq: APTX) recently published a review article in Medicine in Drug Discovery detailing the potential therapeutic benefits of its NMDA receptor modulator, NYX-2925, in treating chronic centralized pain. The data from multiple preclinical models demonstrated robust activity, suggesting a promising safety and efficacy profile. NYX-2925 has shown clear signals of effectiveness in two Phase 2 studies and is advancing toward completion in the first half of 2022. The FDA has granted it Fast Track designation for neuropathic pain treatment.

Positive
  • Successful publication in a scientific journal highlighting NYX-2925's efficacy in chronic pain.
  • NYX-2925 shows robust activity in preclinical models and positive Phase 2 study signals.
  • FDA Fast Track designation for NYX-2925 for the treatment of neuropathic pain.
Negative
  • None.

Aptinyx Inc. (Nasdaq: APTX), a clinical-stage biopharmaceutical company developing transformative therapies for the treatment of brain and nervous system disorders, today announced the publication of a recent review article in Medicine in Drug Discovery featuring data on its novel NMDA receptor modulator, NYX-2925. The data span across numerous preclinical models and highlight the potential therapeutic benefits of NYX-2925 in treating chronic, centralized pain conditions.

“This article in Medicine in Drug Discovery showcases our methodical approach to CNS drug development and also highlights the important role NYX-2925 could play in treating centralized chronic pain,” said Norbert Riedel, Ph.D., chief executive officer of Aptinyx. “We have thoroughly characterized the effects of NYX-2925 across numerous preclinical pain models and have seen robust, consistent, and reproducible activity that suggests a differentiated safety and efficacy profile. As we have now advanced NYX-2925 through two Phase 2 studies and observed clear signals of activity on several biomarkers as well as patient-reported measures, these foundational preclinical data continue to be important to our understanding of the unique mechanism of NMDA receptor modulation and its role in addressing aberrant central pain processing. Given all of the compelling evidence we have gathered to date with NYX-2925, we are eager to complete the two ongoing Phase 2b studies in the first half of 2022 and to move closer to our goal of bringing NYX-2925 to patients in need of better therapeutic options.”

The review describes the role of central (brain) changes that occur as pain is experienced chronically. These changes can lead to a maladaptive state that creates a lifelong pain sensation despite the absence of painful peripheral (sensory) stimuli. Disruptions in NMDA receptor activity and expression have been implicated in chronic pain states and this review presents preclinical data from a variety of preclinical pain models describing the analgesic effects exhibited by the novel NMDA receptor modulation of NYX-2925.

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, therapeutic effects of the company’s product candidates, expectations regarding the design, implementation, timing, and success of its current and planned clinical trials, expectations regarding its preclinical development activities, 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; 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 in its other filings and reports with the United States 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.

FAQ

What is the purpose of the NYX-2925 clinical trials?

The NYX-2925 clinical trials aim to evaluate its effectiveness in treating chronic pain associated with central nervous system disorders.

What were the results of the NYX-2925 Phase 2 studies?

The Phase 2 studies of NYX-2925 demonstrated clear signals of activity on various biomarkers and patient-reported outcomes.

What does the publication in <i>Medicine in Drug Discovery</i> reveal about NYX-2925?

The publication highlights preclinical data supporting NYX-2925's analgesic effects and its potential to modulate central pain processing.

When does Aptinyx expect to complete the ongoing Phase 2b studies for NYX-2925?

Aptinyx anticipates completing the two ongoing Phase 2b studies in the first half of 2022.

What is the significance of the FDA Fast Track designation for NYX-2925?

The FDA Fast Track designation facilitates the development and expedited review of NYX-2925 for treating neuropathic pain, reflecting its potential therapeutic benefit.

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