Ovid Therapeutics has released positive topline data from its Phase I trial involving healthy volunteers, evaluating OV329, a next-generation gamma-aminobutyric acid (GABA)-aminotransferase (GABA-AT) inhibitor under development for drug-resistant epilepsy.
The trial focused on assessing the pharmacodynamics, pharmacokinetics, tolerability and safety of the therapy, revealing inhibitory activity and a potential safety profile.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Ovid Therapeutics chairman and CEO Dr Jeremy Levin said: “OV329 was designed to deliver the benefits of a novel GABA-AT inhibitor while avoiding the challenges of existing medicines.
“Our Phase I trial generated the first-in-human data, supported by what we believe is the most extensive biomarker programme in early seizure drug development, showing consistent results across multiple validated measures and demonstrating a clean ocular and overall safety profile.”
The study assessed OV329 in 68 healthy participants, comprising 51 individuals receiving the active treatment and 17 receiving a placebo, across both multiple and single ascending dose cohorts.
Doses ranging from 1mg to 5mg were tested as part of the trial, safety assessments of which included ophthalmic evaluations.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataComprehensive exploratory biomarker analyses were performed in the 3mg and 5mg multiple ascending dose cohorts.
These analyses utilised transcranial magnetic stimulation, as measured by electromyography, to implement established metrics for assessing anti-seizure medications, including long-interval intracortical inhibition and the cortical silent period.
Furthermore, electroencephalography and magnetic resonance spectroscopy were examined to investigate markers of target engagement and inhibitory activity.
OV329 showed a favourable tolerability and safety profile in the trial and all potentially adverse events related to the treatment were observed to be mild and transient.
Additionally, Ovid is planning to launch a Phase IIa randomised placebo-controlled trial of OV329.
This trial, set to be initiated in the second quarter of 2026, will evaluate the therapy in adults with drug-resistant focal onset seizures, with completion anticipated in mid-2027.
