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Aptinyx provides update on NYX-783 development program for the treatment of post-traumatic stress disorder

By Reshma on Jun 16, 2021 | 04:36 AM IST

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Aptinyx Inc. [APTX], a clinical-stage biopharmaceutical company developing transformative therapies for the treatment of nervous system disorders, today announced that it has finalized the design of its Phase 2b program for NYX-783 in patients with post-traumatic stress disorder (PTSD) after having received the minutes from its recent Type C meeting with the U.S. Food and Drug Administration (FDA). The company expects to initiate the Phase 2b program in the fourth quarter of 2021. Aptinyx also announced that, in its preparation for Phase 2b, it identified a statistical error made by the contract research organization (CRO) that performed the statistical analysis of the previously completed exploratory Phase 2 study in PTSD. Accordingly, the company is providing updated statistical analysis for the exploratory Phase 2 study, which has no impact on the study conclusions.

“We are pleased to be moving forward with Phase 2b development of NYX-783 in PTSD and believe that its mechanism of enhancing extinction learning through NMDA receptor modulation has the potential to address the putative underlying pathology of PTSD,” said Norbert Riedel, Ph.D., chief executive officer of Aptinyx. “Upon identifying the error in statistical analysis made by the CRO in our previous study, we have moved quickly to reanalyze and release revised statistical analysis. It is important to note that 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. We look forward to advancing NYX-783 into Phase 2b starting in the fourth quarter of this year.”

 


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