Aptinyx Reports Positive, Statistically Significant, Top-line Data From Phase 2 Study of NYX-783 in Patients With Post-Traumatic Stress Disorder - Seite 2

The improvements on the primary, clinician-administered CAPS-5 endpoints were concordant with improvements observed on multiple secondary and exploratory endpoints.

Across endpoints in the study, a clear dose response was evident with the 50 mg dose demonstrating more consistent effects than the 10 mg dose.

In the study, NYX-783 was well tolerated and exhibited a favorable adverse event profile.

“We are very pleased with these impressive results, which surpassed our expectations for this initial exploratory study and clearly indicate the strong potential of NYX-783 to rapidly and reliably address some of the most challenging symptoms of PTSD,” said Norbert Riedel, Ph.D., president and chief executive officer of Aptinyx. “People suffering from PTSD have immense unmet medical needs and the few existing therapeutic options offer limited benefit. We believe these results indicate that the mechanism of NYX-783, which modulates NMDA receptors to enhance extinction learning, addresses the putative underlying pathology of PTSD. We expect the data from this study will support discussion with the FDA and the initiation of a first pivotal study. In addition, these results provide further clinical validation of our NMDA receptor modulation platform and reinforce our confidence in its therapeutic utility across our other clinical-stage programs in chronic pain and cognition.”

Aptinyx plans to discuss these results on a conference call scheduled for 8:30 a.m. ET tomorrow. Additionally, the company plans to submit the detailed results from this study for publication and presentation at future scientific and medical meetings.

About the Phase 2 Exploratory Study of NYX-783 in PTSD

The Phase 2 exploratory study was a multi-center, placebo-controlled, double-blind, randomized, Sequential Parallel Comparison Design (SPCD) study of 153 patients with PTSD, as characterized by criteria set forth in the Diagnostic and Statistical Manual of Mental Disorders, 5^th Edition (DSM-5).

In accordance with the SPCD design, the study was conducted in two, four-week sequential stages. No patient in the study received more than 4 weeks of NYX-783 treatment. Patients were randomly assigned to receive placebo, NYX-783 10 mg, or NYX-783 50 mg in Stage 1. Patients on placebo in Stage 1 were re-randomized in Stage 2 to again receive placebo, or start NYX-783 10 mg, or NYX-783 50 mg. All patients from Stage 1 as well as the patients in the placebo non-responder group at week 4 (defined as CAPS-5 total score >26 and a percent-reduction from baseline in CAPS-5 total score of <35% at week 4), in Stage 2 were combined for primary efficacy analysis. The primary endpoint of the study was the change in CAPS-5 Total Score and symptom domain sub-scores (Arousal and Reactivity, Negative Cognitions and Mood, Intrusions, and Avoidance) for Stage 1 and Stage 2, combined as weighted effects. In total, the Phase 2 study duration was ten to thirteen weeks overall, consisting of a screening period, two four-week treatment periods (Stage 1 and Stage 2), and a safety follow-up period.