Aptinyx has reported that its investigational therapy, NYX-2925, failed to meet the primary endpoint of the Phase IIb clinical trial in painful diabetic peripheral neuropathy (DPN) patients. 

NYX-2925 is a new oral NMDA receptor positive allosteric modulator (PAM).

The randomised, placebo-controlled, double-blind trial analysed the safety and efficacy of NYX-2925 in 229 subjects with advanced painful DPN

On concluding the screening period, eligible subjects were divided to receive oral doses of 50mg NYX-2925 or a placebo once a day. 

The variation from baseline in average daily pain as assessed on the zero-to-ten numeric rating scale during week 12 of the trial was the primary endpoint.

Worst daily pain, pain on walking and pain affecting sleep were included as further pain endpoints in the trial.

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Findings showed that treatment with NYX-2925 did not attain a statistical significance difference versus placebo on the primary endpoint.

Subjects in the NYX-2925 arm demonstrated an improvement in average daily pain scores while the variation between NYX-2925 and placebo was also not reported on other pain endpoints of the trial. 

NYX-2925 was found to be well-tolerated without any concerning safety issues reported. 

In various trials, the oral therapy showed activity that impacts central, supraspinal pain processing, causing improvement in pain and other symptoms linked to specific chronic pain conditions. 

Aptinyx president and CEO Andy Kidd said: “Unfortunately, the data from this study do not currently point to a path forward in development for painful DPN.”

“We continue to believe, however, that NYX-2925 can offer a novel therapeutic approach for fibromyalgia, a disorder fundamentally characterised by abnormal pain processing in the brain. 

“To this end, we look forward to reporting data from our ongoing fibromyalgia Phase IIb study in early to mid Q3.”

In March this year, the company completed participant enrolment in the Phase IIb trial of NYX-2925 for fibromyalgia.