Ovid Therapeutics Announces Initiation of Two Phase 2 Clinical Trials of OV935/TAK-935 for Pediatric Patients with Rare Epilepsies

Ovid Therapeutics (NASDAQ:OVID), a biopharmaceutical company committed to developing medicines that transform the lives of people with rare neurological diseases, today announced initiations of the Phase 2 ELEKTRA and ARCADE trials for OV935/TAK-935 in pediatric patients with rare epilepsies.

As quoted in the press release:

The Phase 2 ELEKTRA trial is a multi-center, randomized, double-blind, placebo-controlled, parallel-design, clinical trial of OV935 in pediatric patients with Dravet syndrome or Lennox-Gastaut syndrome (LGS). The trial is expected to enroll 126 patients aged 2 to 17 years old at clinical sites worldwide. The Phase 2 ARCADE trial is a multi-center, open-label, pilot study of OV935 in pediatric patients with CDKL5 deficiency disorder (CDD) or Duplication 15q (Dup15q) syndrome. Approximately 30 total patients – 15 children with each condition – aged 2 to 17 years old are expected to be enrolled. Each study will assess the effects of OV935 on efficacy, safety and tolerability.

OV935 is a potent, highly-selective, first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase (CH24H) that is being investigated as an anti-epileptic drug (AED) in a range of developmental and epileptic encephalopathies (DEE). DEE is a term for a specific group of rare epilepsy conditions that typically present early in life and are often associated with severe cognitive and developmental impairment in addition to frequent treatment-resistant seizures throughout the person’s lifetime. These disorders vary in age of onset, developmental outcomes, etiologies, neuropsychological deficits, electroencephalographic (EEG) patterns, seizure types and prognosis.

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