APTX - Aptinyx updates on mid-stage clinical program for PTSD therapy

Devonyu/iStock via Getty Images Aptinyx (APTX) says that after a Type C meeting with the FDA held recently it 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), the company said adding that they will be multi-center, placebo-controlled, double-blind, randomized trials. Study 1 is expected to start in Q4 2021 while Study 2 is on track for commencement in Q1 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,” noted

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Aptinyx updates on mid-stage clinical program for PTSD therapy