P387. PRAX-114, An Extrasynaptic-Preferring GABAA Receptor Positive Allosteric Modulator: A Phase 2 Trial Evaluating Multiple Dose Safety, Tolerability, and Preliminary Efficacy in Major Depressive Disorder

Abstract

PRAX-114 is an extrasynaptic-preferring GABAA receptor positive allosteric modulator in development for treatment of major depressive disorder (MDD). Extrasynaptic preference was hypothesized to explain preclinical findings demonstrating >20-fold separation between antidepressant- and sedative-like doses in rodents, and the lack of dose-limiting sedation in a Phase 1 trial assessing PRAX-114 safety and tolerability in healthy participants. Here we report results from an open-label Phase 2 trial assessing safety, tolerability and preliminary efficacy in MDD.