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

- September 24th, 2018

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, … Continued

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.

Click here to read the full press release.

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