Aptinyx’s NYX-2925 Demonstrates Positive Data in Fibromyalgia

Aptinyx Inc. announced positive top-line results from a 23-patient, single-blind, Phase 2 study of its novel NMDA receptor modulator, NYX-2925, in patients with fibromyalgia. Administration of NYX-2925 resulted in statistically significant effects on the primary endpoint, brain activity biomarkers associated with central pain processing, measured using advanced imaging techniques. Clinically meaningful improvements were also observed on secondary patient-reported endpoints, including pain scores, the Revised Fibromyalgia Impact Questionnaire (FIQR), and other fibromyalgia symptom scales. 
 
The brain activity biomarkers and improvements in patient-reported pain were correlated. Based on these results, the company will begin enrollment in a larger, 12-week, randomized, placebo-controlled study in patients with fibromyalgia in the second half of 2019, which will evaluate patient-reported outcomes as the primary endpoint.
 
“The statistically significant effects on both pain-related brain activity and patient-reported clinical measures elegantly demonstrates that NYX-2925 is acting in the brain to alter pain processing, leading to pain alleviation,” said Norbert Riedel, Ph.D., president and chief executive officer of Aptinyx. “The results of this study reinforce what we observed in patients with advanced painful diabetic peripheral neuropathy in our recent Phase 2 DPN study, in which NYX-2925 greatly alleviated the centralized pain that is predominant in these patients. The consistency of these data confirms our confidence in advancing NYX-2925 as a treatment for chronic pain. We look forward to initiating follow-up studies in both painful DPN and fibromyalgia later this year.”