Aptinyx Initiates Phase 2b Study of NYX-783 in Patients with Post-Traumatic Stress Disorder
December 16, 2021 at 07:37 AM EST
Aptinyx Inc. (Nasdaq: APTX), a clinical-stage biopharmaceutical company developing transformative therapies for the treatment of brain and nervous system disorders, today announced the initiation of a Phase 2b study evaluating 50 mg QD of NYX-783 in 300 patients with post-traumatic stress disorder (PTSD). The Phase 2b study is designed to be well-positioned for consideration as registration-supportive, taking into account guidance received in a Type C meeting with the U.S. Food and Drug Administration (FDA) earlier this year. Initiation of this study follows the observation of clinically meaningful symptom improvements in a previously completed exploratory Phase 2a study of NYX-783 in PTSD. The company anticipates reporting data from the Phase 2b study in the second half of 2023.
“New therapeutic approaches are urgently needed for the millions of people living with PTSD,” said Chadi Abdallah, M.D., Associate Professor and Beth K. and Stuart C. Yudofsky Chair in the Neuropsychiatry of Military Post-Traumatic Stress Syndrome at Baylor College of Medicine. “The safety profile and encouraging efficacy signals observed in prior clinical studies of NYX-783 highlight its therapeutic potential and suggest NMDA receptor modulation may represent a promising and innovative mechanism for the treatment of this devastating neuropsychiatric disorder.”
“Today’s study initiation is an important step forward on the path to establishing NYX-783 as a novel treatment option for patients with PTSD,” said Norbert Riedel, Ph.D., chief executive officer of Aptinyx. “This is the first of two well-controlled Phase 2b studies that will evaluate different dose levels of NYX-783. The level of unmet need surrounding PTSD and mental health has never been more prevalent than it is today, and we are excited to be advancing NYX-783 into late-stage development for a disease area that has not seen a new therapy approved in over 20 years.”
About the NYX-783 Phase 2b PTSD Program
In the first Phase 2b study, approximately 300 patients will be randomized to receive either placebo or 50 mg of NYX-783 administered orally once daily. The study will comprise a 1- to 4-week screening period, a 10-week treatment period, and a follow-up evaluation period. Following the initiation of the 50 mg study, a second Phase 2b study will commence in which approximately 300 patients will be randomized to receive either placebo or 150 mg of NYX-783 administered orally once daily. The other design parameters of the 150 mg study will be consistent with those of the 50 mg study.
About Post-Traumatic Stress Disorder
Source: Aptinyx Inc.