Ovid Therapeutics Inc. dosed healthy volunteers with OV329 in late December 2022, as part of a Phase 1 study. The Company is conducting the study to evaluate the safety and target engagement associated with single and repeated doses of OV329. The Phase 1 study of OV329 is a first-in-human, randomized, double-blind, placebo-controlled trial that is being conducted at Duke University School of Medicine.

The trial is structured in two parts, beginning with a single-ascending dose portion and followed by a multiple-ascending dose portion. Both parts are cohort gated. This study in healthy volunteers will explore several endpoints including safety, tolerability, pharmacokinetics, and target engagement levels as measured by magnetic resonance spectrometry (MRS).

GABA-AT target engagement levels may be a potential indicator of OV329's potential therapeutic effect because specified increases in GABA have previously been correlated to seizure reduction. Ovid expects to enroll more than 60 individuals in this trial and anticipates final results in the first half of 2024.