Aptinyx Hosts Virtual Portfolio Review Event to Showcase NYX-2925 in Chronic Pain and Provide Update on Clinical Development Programs

Rhea-AI Summary

Aptinyx Inc. (APTX) hosted a virtual portfolio review to discuss its NMDA receptor modulators, focusing on NYX-2925 for chronic pain. Currently in Phase 2b trials for diabetic peripheral neuropathy and fibromyalgia, NYX-2925 has shown promise in pain alleviation with a favorable safety profile. The company is also advancing NYX-783 for PTSD, with two Phase 2b trials planned. NYX-458 is under evaluation for cognitive impairment in Parkinson's patients. APTX expects data releases from these programs in the coming months.

Positive

• NYX-2925 shows promise in Phase 2b studies for chronic pain with a favorable safety profile.
• Fast Track designation granted by the FDA for NYX-2925 and NYX-783.
• Upcoming data from DPN study expected in April/May 2022 and from fibromyalgia study in mid-2022.
• Potential therapeutic applications for multiple conditions, including PTSD and cognitive impairment.

Negative

• No data reported yet from ongoing clinical trials, contributing to uncertainty.
• Delays in reporting data for NYX-458 and other candidates might affect investor sentiment.

Live webcast today beginning at 10:00 a.m. ET

EVANSTON, Ill.--(BUSINESS WIRE)-- Aptinyx Inc. (Nasdaq: APTX), a clinical-stage biopharmaceutical company developing transformative therapies for the treatment of brain and nervous system disorders, will host a virtual portfolio review event today beginning at 10:00 a.m. ET. Presented in a live webcast format, the company will discuss its approach to the development of novel NMDA receptor modulators and review its pipeline of four clinical development programs, with particular focus on NYX-2925 in chronic pain.

NYX-2925 is an NMDA receptor positive allosteric modulator (PAM) currently under evaluation in a Phase 2b study in patients with painful diabetic peripheral neuropathy (DPN) and a Phase 2b study in patients with fibromyalgia. Today’s program will feature presentations from the Aptinyx management team as well as Richard Rauck, MD, a board-certified physician in pain medicine and anesthesiology at Carolinas Pain Institute and an investigator in the company’s ongoing Phase 2b painful DPN study. Aptinyx expects to report data from the Phase 2b painful DPN study in April or early May and anticipates reporting data from the Phase 2b fibromyalgia study in mid 2022.

The event will also highlight Aptinyx’s two other NMDA receptor PAMs currently in Phase 2 clinical development. The company’s compound, NYX-783, is in development for the treatment of post-traumatic stress disorder (PTSD). The company is conducting two Phase 2b studies of NYX-783 in patients with PTSD: the first, evaluating a 50 mg dose level, initiated in 4Q 2023; and the second, which will evaluate a 150 mg dose level, is expected to commence in 1Q 2023. Aptinyx is also developing its compound, NYX-458, for the treatment of cognitive impairment. NYX-458 is currently under evaluation in an exploratory Phase 2 study in patients with cognitive impairment associated with Parkinson’s disease and dementia with Lewy bodies. The company expects to report data from this study in 4Q 2022 or 1Q 2023.

The Aptinyx management team and Dr. Rauck will be available for Q&A following the presentations. The live webcast and accompanying presentation can be accessed on the Investor Relations section of the Aptinyx website here and a replay of the webcast will be posted following the conclusion of the event.

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 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, expectations, and potential therapeutic effects of its development candidates, expectations regarding the timing for the company’s receipt and announcement of data, and expectations regarding its preclinical development activities. 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; that 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; 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220209005426/en/

Investor & Media Contact:

Patrick Flavin

Aptinyx Inc.

ir@aptinyx.com or corporate@aptinyx.com

847-871-0377

Source: Aptinyx Inc.

FAQ

What is the focus of the Aptinyx virtual event on February 9, 2022?

The event focuses on Aptinyx's NMDA receptor modulators, particularly NYX-2925 for chronic pain and updates on their clinical pipeline.

What are the current clinical trials for NYX-2925?

NYX-2925 is being evaluated in Phase 2b studies for painful diabetic peripheral neuropathy and fibromyalgia.

When will Aptinyx report data from its Phase 2b studies?

Aptinyx expects to report data from the Phase 2b painful DPN study in April or early May 2022, and from the fibromyalgia study in mid-2022.

What other drug candidates is Aptinyx developing?

Aptinyx is also developing NYX-783 for PTSD and NYX-458 for cognitive impairment associated with Parkinson's disease.

Is NYX-2925 approved by the FDA?

Yes, NYX-2925 has received Fast Track designation from the FDA for neuropathic pain associated with diabetic peripheral neuropathy.