Aptinyx Inc. announced that data from preclinical studies of NYX-783 in models of post-traumatic stress disorder (PTSD) will be presented in a poster at the American Psychiatric Association Annual Meeting being held May 21 – 25, 2022 in New Orleans, LA. The poster highlights data from preclinical studies showing that NYX-783, an NMDA receptor positive allosteric modulator, builds long-lasting fear-inhibitory memories in PTSD-relevant models, ultimately leading to reduced spontaneous recovery (i.e., return) of fear. NYX-783 is currently being evaluated in a Phase 2b study in patients with PTSD.

Approximately fifteen million adults in the United States suffer from PTSD in a given year, which is characterized by intrusive symptoms, avoidance, negative alteration in cognition and mood, hyperarousal, and/or arousal alterations following the experience of trauma. PTSD can result from various forms of trauma, including combat exposure, car accidents, sexual or other physical assault, abuse, natural disasters, and others. The lifetime prevalence of PTSD is approximately 7% in the general population but is much higher in populations at risk for exposure to trauma, such as military service members and first responders.

In addition to the challenges associated with the direct symptoms, PTSD sufferers have a higher rate of suicide and often struggle with simultaneous addiction, leading to an even greater social and economic burden of the disorder. Available therapeutic options are limited in treating PTSD, including only two approved conventional SSRI antidepressants, which have limited efficacy, undesirable side effects, and target only the symptoms of PTSD, not the underlying disorder itself. NYX-783 is a novel, oral, positive allosteric modulator of NMDA receptors currently in Phase 2b development for the treatment of post-traumatic stress disorder (PTSD).

In preclinical studies of NYX-783, particularly strong results were observed in psychiatric models, models of fear extinction, and models of substance abuse. In a Phase 1 clinical study of NYX-783, ample central nervous system exposure was observed and the product candidate demonstrated a favorable adverse event and tolerability profile, with no serious adverse effects, across a wide dose range. In an exploratory Phase 2a study in patients with PTSD, patients receiving a 50 mg dose level of NYX-783 showed meaningful symptom improvements and rates of response.

The U.S. Food and Drug Administration has granted Fast Track designation to the development of NYX-783 for the treatment of PTSD.