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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.
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Study Result summary3 Oct, 2025

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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Q3 202511 Nov, 2025
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Frequently asked questions

Ovid Therapeutics Inc. is a biopharmaceutical company focused on developing treatments for rare neurological disorders. The company specializes in small-molecule and genetic-based therapies targeting conditions such as epilepsies and neurodevelopmental syndromes. Its research and development efforts aim to advance novel drug candidates through clinical trials and regulatory approvals. The company is headquartered in New York, New York, and its shares are listed on the NASDAQ.

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