Within Six Months Aptinyx's Another Development Candidate Goes Up In Smoke

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  • Aptinyx Inc APTX 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 the placebo on the study's efficacy endpoints. 
  • The results do not support further development of NYX-458 by the company.
  • The Phase 2 study enrolled 99 patients. The study evaluated daily oral dosing of a 30 mg dose level of NYX-458 compared to a placebo over 12 weeks. 
  • Across the overall study population, NYX-458 did not demonstrate clinically meaningful improvements over the placebo on the study's efficacy endpoints. 
  • These endpoints evaluated everyday function and cognitive performance. NYX-458 was well-tolerated in the study. 
  • The company intends to undertake cost-cutting measures and the exploration of strategic alternatives. The company will terminate its ongoing Phase 2b study of NYX-783 in post-traumatic stress disorder (PTSD) and analyze the data to date to inform the next steps for the program.
  • In August, Aptinyx's fibromyalgia candidate, NYX-2925, failed to achieve statistically significant separation from placebo on the study's primary endpoint of change in average daily pain.
  • Price Action: APTX shares are down 65.9% at $0.20 during the premarket session on the last check Tuesday.
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