Aptinyx completes enrollment in Phase 2 diabetic neuropathy study

Aptinyx announced enrollment completion for the company’s Phase 2 study of NYX-2925 for the treatment of painful diabetic peripheral neuropathy. NYX-2925 is a novel modulator of NMDA receptors and its development for painful DPN has been granted Fast Track designation by the U.S. Food and Drug Administration. The company expects to announce top-line data from the study early in the first quarter of 2019. The study is a randomized, double-blind, placebo-controlled study in which subjects receive oral, once-daily dosing of either placebo or NYX-2925 for four weeks. The primary endpoint of the study is the change in subjects’ average daily pain scores on the Numerical Rating Scale between the baseline period and the fourth week of treatment. Multiple dose levels of NYX-2925 are under evaluation in the study. Secondary endpoints include the effect of NYX-2925 on pain characteristics, sleep interference, and psychological state, as well as further assessment of safety and tolerability. The company is conducting the study across 35 sites in the U.S. and has achieved the targeted enrollment of 300 subjects.
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