- After a Type C meeting with the FDA, Aptinyx Inc APTX has finalized the design of its Phase 2b program for NYX-783 in patients with post-traumatic stress disorder (PTSD).
- The program will consist of two separate studies to evaluate NYX-783 at two dose levels: 50 mg (Study 1) and 150 mg (Study 2).
- Both the studies will have 300 patients each.
- Study 1 will start in Q4 of 2021, while Study 2 will commence in Q1 of 2022.
- Additionally, Aptinyx disclosed an updated statistical analysis for the recently concluded exploratory Phase 2 study in PTSD after detecting a statistical error made by its contract research organization.
- “The revised analysis does not impact our conclusions from that study, our confidence in the efficacy and safety profile of NYX-783, or our next steps in its clinical development,” said Norbert Riedel, CEO of the company.
- After updated statistical analysis, certain study calculations such as CAPS-5 Arousal & Reactivity score and CAPS-5 Negative Cognitions and Mood score for the 50 mg dose vs. placebo had higher p-values than previously reported.
- But each remains below the significance threshold pre-specified in the statistical analysis plan, it added.
- Price Action: APTX shares are down 10.60% at $3.12 in the premarket session on the last check Wednesday.
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