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Ovid Therapeutics (OVID) investor relations material
Ovid Therapeutics Study Result summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Pipeline overview and unmet need
OV329 is a next-generation GABA aminotransferase inhibitor targeting neural hyperexcitability disorders, including drug-resistant epilepsy and CNS diseases, with a differentiated mechanism from existing therapies.
Pipeline includes OV329 for treatment-resistant epilepsies and KCC2 direct activators for CNS indications.
Significant unmet need remains in epilepsy, with many patients experiencing uncontrolled seizures despite multiple approved drugs.
OV329 aims to address safety and tolerability issues seen with first-generation GABA modulators like vigabatrin.
Market opportunity exceeds $1 billion annually, with a target population of 65,000 adults in the U.S.
Study design and objectives
Phase 1 trial evaluated OV329 in 68–69 healthy volunteers, assessing safety, tolerability, pharmacokinetics, and pharmacodynamics across single and multiple ascending dose cohorts (1–5 mg).
Extensive biomarker analyses included TMS, MRS, and EEG to measure GABAergic inhibition and brain engagement.
OV329 was compared to placebo and to published data for vigabatrin, a first-generation GABA-AT inhibitor.
The Phase 1 study evaluated safety, pharmacokinetics, pharmacodynamics, and biomarker effects in healthy volunteers to inform Phase 2 dosing.
OV329 is designed for once-daily oral dosing, with lower anticipated human doses compared to existing therapies.
Safety and tolerability results
OV329 demonstrated a strong safety profile with only mild, transient adverse events and no serious treatment-related or ophthalmic events.
No ocular or retinal changes were observed, supported by rigorous ophthalmic safety monitoring and preclinical studies.
No evidence of drug accumulation in the eye, differentiating OV329 from vigabatrin and reducing risk of vision loss.
No titration is anticipated for future dosing due to the clean safety profile.
All potentially treatment-related adverse events were mild and transient, including headache, drowsiness, and metallic taste.
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