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Aptinyx Initiates Phase 1 Study of NYX-458
Development in Parkinson’s Disease Cognitive Impairment Planned
EVANSTON, Ill., Aug. 02, 2018 (GLOBE NEWSWIRE) -- Aptinyx Inc. (NASDAQ:APTX), a clinical-stage biopharmaceutical company developing transformative therapies for the treatment of brain and nervous system disorders, today announced initiation of Phase 1 clinical development of NYX-458, its third novel product candidate that modulates N-methyl-D-aspartate (NMDA) receptors.
The randomized, double-blind, placebo-controlled Phase 1 study will enroll approximately 62 healthy volunteers to evaluate the safety, tolerability, and pharmacokinetics of single and repeat dosing of NYX-458 at multiple dose levels. Aptinyx intends to develop NYX-458 for the treatment of cognitive impairment associated with Parkinson’s disease and plans to advance the compound into studies to evaluate efficacy next year.
“Based on the compelling preclinical evidence of NYX-458 in reversing cognitive impairment, we are excited to initiate this first-in-human study and advance NYX-458 as a potential treatment for this very common and highly limiting, but poorly treated, symptom of Parkinson’s disease,” said Torsten Madsen, M.D., Ph.D., chief medical officer of Aptinyx. “With NYX-458, we now have three product candidates in clinical development, further demonstrating the broad applicability of our discovery platform.”
Through NMDA receptor modulation, NYX-458 enhances synaptic plasticity to improve neural cell communication, which may translate into improvements in learning, memory, and cognition, the deterioration of which is increasingly recognized as a major component of Parkinson’s disease.
Aptinyx’s chemistry and discovery platform has generated numerous novel small-molecule modulators of the NMDA receptor, including the company’s three product candidates in clinical development, NYX-2925, NYX-783, and NYX-458. In studies to date, these molecules have demonstrated high oral bioavailability, diverse NMDA receptor subtype binding profiles and pharmacology, and differentiated efficacy in preclinical models of various nervous system conditions.
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 for the treatment of chronic pain, post-traumatic stress disorder (PTSD), 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.
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 our business plans and objectives, expectations regarding the design, implementation, enrollment, timing and success of our clinical trials and planned clinical trials, expectations regarding our preclinical development activities, and plans related to development of our current and future product candidates in additional indications. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost and timing of our product candidate development activities and planned clinical trials; our ability to execute on our strategy; regulatory developments in the United States and foreign countries; and our estimates regarding expenses, future revenue and capital requirements. These and other risks and uncertainties are described more fully under the caption "Risk Factors" in the final prospectus, dated June 20, 2018 and filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, with the United States Securities and Exchange Commission (SEC) and elsewhere in Aptinyx's filings and reports with the SEC. 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.
Director, Corporate Development