Aptinyx : NYX-2925 Fails To Achieve Separation From Placebo On Primary Endpoint

(RTTNews) - Aptinyx Inc. (APTX) announced 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. Of the three dose levels evaluated, 50 mg showed the most meaningful improvements across multiple measures. NYX-2925 was well tolerated in the study with no serious adverse events.

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.