Ovid Therapeutics Dosed Healthy Volunteers With OV329 in Phase 1 Trial

Ovid Therapeutics Inc. recently 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.

“Inhibiting the GABA-aminotransferase (GABA-AT) enzyme is a validated mechanism for reducing seizures,” said Dr. Claude Nicaise, Head of Research & Development at Ovid. “We believe OV329 is an improved, potent GABA-AT inhibitor that may confer robust seizure reduction, an improved safety profile, and preferred dosing relative to the current medicine in the class. We thank the epilepsy community and individuals participating in this Phase 1 study. Results will inform our development plans, and hopefully, enable us to rapidly advance into trials with people experiencing treatment-resistant seizures.”

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.

“We are thrilled to see continued innovation for rare epilepsies, as many of the children and their families in our community do not find current treatments satisfactory,” said Amy E. Brin, CEO of the Child Neurology Foundation. “Families living with rare forms of epilepsy, such as infantile spasms and seizures associated with tuberous sclerosis complex, would benefit from more treatment options, and we look forward to seeing results from these studies.”

To learn more about the OV329 healthy volunteer study, contact Info@OvidRx.com.

OV329 is a next-generation GABA-aminotransferase (GABA-AT) inhibitor being developed for the potential treatment of rare and treatment-resistant forms of epilepsy and seizures, such as seizures associated with tuberous sclerosis complex, infantile spasms, and conditions with focal onset seizures. Low levels of GABA, the primary inhibitory neurotransmitter in the brain, have been linked to neuronal hyperexcitability. OV329 is believed to work by reducing the activity of GABA-AT, thereby increasing levels of GABA in the brain, and potentially suppressing neuronal hyperexcitability known to cause seizures. OV329 may be a potential best-in-class GABA-AT inhibitor that could offer enhanced efficacy, an improved safety profile and more optimal dosing.

Ovid Therapeutics Inc. is a New York-based biopharmaceutical company striving to conquer seizures and brain disorders with courageous science. Ovid’s pipeline of small molecule and genetic medicines candidates seek to meaningfully improve the lives of people and families affected by epilepsies. Ovid is developing OV329, a GABA-aminotransferase inhibitor, for treatment-resistant seizures, and OV350, a direct activator of the KCC2 transporter, for potential treatment of epilepsies. In addition, Ovid maintains a significant financial interest in the future regulatory development and potential commercialization of soticlestat, which Takeda is responsible for advancing globally. Soticlestat is a cholesterol 24-hydroxylase inhibitor, which is currently in Phase 3 trials for Dravet and Lennox-Gastaut syndromes. For more information, visit www.ovidrx.com.