The study (NCT04147858) is recommencing after being temporarily suspended in March due to the escalation of COVID-19 in the U.S. Aptinyx has assured patients that the company will take necessary safety precautions to minimize risk to study participants.
“We are very pleased to be restarting this study. It will build on the positive results from our first Phase 2 evaluation of NYX-2925 in patients with fibromyalgia,” Norbert Riedel, PhD, Aptinyx’s president and CEO, said in a press release.
“In support of this recommencement, we have incorporated appropriate precautionary measures designed to conduct this follow-up study safely in the current COVID-19 environment,” he said.
The double-blind Phase 2 study — in which neither researchers nor participants know which patients are receiving the medication and which a placebo — will determine the efficacy and safety of NYX-2925 as a treatment for fibromyalgia in comparison with a placebo.
An estimated 300 patients between the ages of 18 and 75 will be enrolled. After a one- to four-week screening period, the participants will be randomly assigned to receive once-daily oral doses of 50 mg of NYX-2925, 100 mg of NYX-2925, or a placebo over 14 weeks (approximately 3.5 months).
The study’s primary efficacy goal is to measure average daily pain intensity over 12 weeks, based on changes in a 10-point rating scale. Other metrics to be evaluated are patient-reported outcomes, pain reduction, fatigue, cognition, and quality of life.
Patients are being enrolled at 25 study sites in 15 states in the U.S. More information can be found here.
“We will be watching the pace of enrollment closely in the coming months to inform timeline expectations, but currently expect to report data from this study in the first half of 2022,” Riedel added.
NYX-2925 is designed to act by modulating the activity of NMDA receptors, proteins found in nerve cells that play a central role in pain perception and other nervous system processes. The treatment changes how nerve cells communicate with one another, which is ultimately intended to ease pain and other symptoms.
The investigational therapy showed positive safety results in healthy individuals who took part in a Phase 1 study (NCT02834741). A Phase 2 trial (NCT03249103) in women with fibromyalgia found that a lower dose of NYX-2925 (20 mg) affected neuroimaging biomarkers, which was linked with eased pain sensitivity. Nerve cell communication also was lower in brain areas associated with the regulation of chronic pain. A higher 200 mg dose also significantly reduced pain and fatigue, the results showed.