Aptinyx has reported positive top-line data from a Phase II clinical trial that studied NYX-2925 for the treatment of patients suffering from fibromyalgia.
Patients treated with the investigational drug experienced statistically significant reductions in brain activity biomarkers related to central pain processing, the primary endpoint of the trial.
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NYX-2925 also led to statistically significant and clinically meaningful improvements on secondary patient-reported endpoints, including pain scores, the Revised Fibromyalgia Impact Questionnaire (FIQR), and additional fibromyalgia symptom scales.
It was observed that the brain activity biomarkers and improvements in patient-reported pain were correlated.
The single-blind, placebo-controlled, sequential Phase II trial evaluated the efficacy and safety of daily doses of NYX-2925, an NMDA receptor modulator, in 23 female patients with a confirmed diagnosis of fibromyalgia.
Across all study participants, NYX-2925 was well-tolerated without any serious adverse events.
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By GlobalDataAptinyx president and CEO Norbert Riedel said: “The statistically significant effects on both pain-related brain activity and patient-reported clinical measures elegantly demonstrate that NYX-2925 is acting in the brain to alter pain processing, leading to pain alleviation.
“The results of this study reinforce what we observed in patients with advanced painful diabetic peripheral neuropathy in our recent Phase II DPN study, in which NYX-2925 greatly alleviated the centralised pain that is predominant in these patients.”
Based on the data, the company plans to commence enrolment in a 12-week, randomised, placebo-controlled trial in fibromyalgia patients.
The new trial is expected to be initiated in the second half of this year and will measure patient-reported outcomes as the primary endpoint.
