Aptinyx Announces Results of Phase 2 Fibromyalgia Study of NYX-2925 Have Been Selected for Late-Breaking Presentation at the American College of Rheumatology Annual Meeting
Study met primary and secondary endpoints – statistically significant effects on neuroimaging biomarkers and patient-reported measures
ePoster to be presented at ACR Annual Meeting on Tuesday, November 12
EVANSTON, Ill., Oct. 28, 2019 (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 that the results of a Phase 2 study of NYX-2925 in patients with fibromyalgia have been selected for a late-breaking poster presentation at the American College of Rheumatology Annual Meeting. The study was conducted in collaboration with the Chronic Pain and Fatigue Research Center at the University of Michigan Medical School and the Women’s Health Research Program at University of Cincinnati College of Medicine.
“The opportunity to showcase these clinical data in a late-breaking presentation demonstrates their scientific importance in a field in dire need of new therapeutic options,” said Norbert Riedel, Ph.D., president and chief executive officer of Aptinyx. “We and our collaborators at the University of Michigan and the University of Cincinnati are very pleased with the clinical data yielded from this study. These data demonstrate that NYX-2925 is affecting biomarkers known to be associated with centralized pain processing, and that the activity of NYX-2925 resulted in improvements on pain scores and other patient-reported symptoms. Taken together, the imaging data and the clinical outcomes from this study are highly supportive of the continued development of NYX-2925 in chronic centralized pain conditions.”
In the study, patients received daily doses of placebo for two weeks, then 20 mg of NYX-2925 daily for two weeks, followed by 200 mg of NYX-2925 daily for two weeks. During the second week of each of the dosing periods, patients underwent neuroimaging evaluations to assess effects on neural markers of centralized pain processing and fibromyalgia. Throughout the study, patients also reported their symptoms across a number of clinical measures, including daily pain scores, fatigue, and other symptom questionnaires.
Administration of NYX-2925 resulted in statistically significant changes on the neuroimaging markers, the primary endpoint in the study. NYX-2925 administration also resulted in statistically significant and clinically meaningful improvements on pain, fatigue, and other fibromyalgia symptoms. Across all patients in the study, NYX-2925 was safe and well tolerated with no serious adverse events.
“The results from this study are very encouraging based on our previous demonstration of the relevance of these neural markers in patients with fibromyalgia,” said Steven Harte, Ph.D., Associate Research Scientist and Director of Sensory Science, at the Chronic Pain and Fatigue Research Center.“ We were able to objectively measure that NYX-2925 is affecting the apparent central manifestation of pain and other symptoms in these patients—a significant step forward in developing new therapeutic options for fibromyalgia. The effects observed in this study with NYX-2925, both on neural markers and clinical measures, compare favorably to the results we saw in prior studies conducted using approved fibromyalgia treatments and bode well for the next study the company is conducting.”
Fibromyalgia is a chronic condition associated with widespread pain and tenderness, as well as general fatigue. Fibromyalgia is considered by many to be a condition that is largely mediated in the central nervous system, given that fibromyalgia sufferers often present without a direct peripheral insult or injury. People suffering from fibromyalgia also often experience sleep disruption, depressed mood, and cognitive impairment. It is estimated that, in the United States, fibromyalgia affects more than 5 million people. Currently, there are only three FDA-approved pharmacologic treatments for fibromyalgia, but they have limited efficacy and burdensome side effects in many patients.
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 been shown to have 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 preclinical and clinical studies. 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.
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.
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, 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.