Aptinyx Reports Top-line Results from Phase 2 Clinical Study of NYX-2925 in Painful Diabetic Peripheral Neuropathy

Aptinyx (NASDAQ:APTX), a clinical-stage biopharmaceutical company developing transformative therapies for the treatment of brain and nervous system disorders, today announced top-line results from a Phase 2 clinical study of NYX-2925 in subjects with painful diabetic peripheral neuropathy (DPN). In the study, NYX-2925 did not demonstrate statistically significant separation from placebo on the primary endpoint, change in subjects’ average daily pain scores on the Numerical Rating Scale (NRS) during the final treatment week compared to baseline.

As quoted in the press release:

In the randomized, double-blind, placebo-controlled study, 300 subjects with painful DPN received daily oral doses of placebo or NYX-2925 at 10 mg, 50 mg, or 200 mg over the course of four weeks. Subjects were randomized in a 1:1:1:1 ratio. Baseline values for each endpoint were measured over the seven-day period prior to randomization. All subjects in the study had moderate to severe pain at baseline. The primary endpoint of the study was the mean change in average daily pain, as measured using the NRS (on which 0 represents no pain and 10 represents worst pain imaginable), at week four of treatment compared to baseline. Key secondary endpoints in the study included worst daily pain, pain on walking, and sleep interference.

In the study, the 50 mg and 200 mg dose levels of NYX-2925 showed the greatest improvements from baseline, with the 50 mg dose showing numerical superiority. The group treated with 50 mg of NYX-2925 showed a 1.61-point reduction from baseline in average daily pain on the NRS, the largest such reduction among the dose levels evaluated. This improvement did not separate statistically (p=0.1586) from the 1.23-point reduction observed in the placebo group. No plateau in the effect of NYX-2925 at 50 mg was observed by the end of this four-week study, suggesting a longer treatment duration may result in a stronger analgesic effect. Subjects receiving NYX-2925 at 50 mg also had clinically meaningful trends of improvement on key secondary endpoints, including sleep and pain on walking.

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