Aptinyx says Phase 2 Study of NYX-458 did not demonstrate sufficient efficacy

The company states: "Aptinyx announced results from a Phase 2 clinical study evaluating the effects of NYX-458 in patients with cognitive impairment associated with Parkinson’s disease and dementia with Lewy bodies. Across the overall study population, NYX-458 did not demonstrate clinically meaningful improvements over placebo on the study’s efficacy endpoints. The results do not support further development of NYX-458 by the company. The first-in-patient Phase 2 study was a randomized, double-blind, parallel-design, placebo-controlled study in 99 patients with mild cognitive impairment or mild dementia associated with Parkinson’s disease or Dementia with Lewy Bodies. The study evaluated daily oral dosing of a 30 mg dose level of NYX-458 compared to placebo over a 12-week period. Across the overall study population, NYX-458 did not demonstrate clinically meaningful improvements over placebo on the study’s efficacy endpoints. These endpoints evaluated everyday function using the Penn Parkinson’s Daily Activities Questionnaire and the Everyday Cognition-12 Scale, as well as cognitive performance using a battery of computerized neurocognitive tests. NYX-458 was well-tolerated in the study. The results overall do not support further advancement of the development program by Aptinyx. The company intends to undertake cost-cutting measures to preserve capital and support the exploration of strategic alternatives. Consistent with these measures, the company will terminate its ongoing Phase 2b study of NYX-783 in post-traumatic stress disorder and analyze the data to date to inform the next steps for the program."