Takeda and Ovid Therapeutics Expand Clinical Program

On Jul 19, 2018

Takeda Pharmaceutical Company Limited and Ovid Therapeutics Inc. provided an overview of their TAK-935/OV935 broad clinical development program. The companies plan to initiate three clinical trials: in pediatric patients with Dravet syndrome and Lennox-Gastaut syndrome, in pediatric patients with CDKL5 deficiency disorder (CDD) and Duplication 15q (Dup15q) syndrome, and an extension trial for patients with developmental and epileptic encephalopathies (DEEs) who participated in a previous TAK-935/OV935 clinical study. These trials join the clinical development program that includes a fully enrolled Phase 1b/2a trial of adults with DEE. Together, these trials will further investigate the potential of TAK-935/OV935 to modulate the N-Methyl-D-Aspartate (NMDA) signaling receptor, which has been implicated in several neurologic disorders.

“Takeda and Ovid believe that TAK-935/OV935, with its novel mechanism of action, may have the potential to treat rare epilepsies,” said Emiliangelo Ratti, Head of the Neuroscience Therapeutic Area Unit at Takeda. “The expansion of our clinical program to include pediatric populations, and additional rare epilepsies, exemplifies our joint commitment to identify an innovative treatment option for 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.

“Together with Takeda, we continue to make significant progress in our broad development program of TAK-935/OV935 across a range of rare epilepsies and age groups,” said Jeremy Levin, DPhil, MB, BChir, chairman and chief executive officer of Ovid Therapeutics. “The advancement of our development program into younger patients and those with CDKL5 deficiency or Duplication 15q syndrome reflects the strength and quality of our alliance. Takeda’s global reach and operational expertise have been outstanding and with our shared capabilities and commitment, we hope to make a difference for many individuals living with rare epilepsies who have few or limited treatment options.”

The Three Planned Clinical Studies Are:

Phase 2 ARCADE Trial: The ARCADE trial is a Phase 2, multicenter, open-label, pilot study designed to evaluate pediatric patients, aged 2 to 17 years old, with either CDD or Dup15q syndrome. The study will enroll approximately 30 patients (about 15 children with each syndrome). The primary objective of this study is to assess the frequency of motor seizures in patients treated with TAK-935/OV935. The key secondary objectives are safety, tolerability and pharmacokinetic (PK) assessments.
Phase 2 ELEKTRA Trial: The ELEKTRA trial is a Phase 2, multicenter, randomized, double-blind, placebo controlled, study designed to evaluate the efficacy, safety and tolerability of TAK-935/OV935 in pediatric patients, aged 2 to 17 years old, with Dravet syndrome or Lennox-Gastaut syndrome. The study is expected to enroll approximately 125 patients. The primary objective of this study is to assess the frequency of seizures in patients treated with TAK-935/OV935 compared to placebo. The key secondary objectives are safety, tolerability and PK assessments.
ENDYMION: The planned trial is a multi-center, open-label, long-term extension study of TAK-935/OV935 in patients with DEEs who participated in a previous TAK-935/OV935 clinical study. The primary objective is to assess the long-term safety and tolerability of TAK-935/OV935 over two years of treatment in patients with rare epilepsies. A secondary endpoint will evaluate the effect of TAK-935/OV935 on seizure frequency over two years.