Takeda Pharmaceutical Company Limited and Ovid Therapeutics have released an overview of the clinical development program for TAK-935/OV935, an investigational drug that is being developed as a potential anti-epileptic drug. For more detailed information, you can view the source press release here, at Takeda’s website.
The investigational drug TAK-935/OV935 is thought to work by inhibiting an enzyme called CH24H. This enzyme plays a role in cholesterol homeostasis in the brain by converting cholesterol to another product called 24-hydroxycholesterol that then moves from the brain to the blood plasma.
So far, pre-clinical research and four Phase 1 clinical trials have been carried out to investigate TAK-935/OV935 as a potential anti-epileptic drug.
The Clinical Development Program
Three more clinical studies are planned to research TAK-935/OV935.
- A Phase 2 ‘Elektra’ clinical trial will involve paediatric patients diagnosed with Lennox-Gastaut syndrome and Dravet syndrome. It is a randomised and double-blind study that will be placebo-controlled. An estimated 125 patients are expected to be enrolled. Researchers are planning to look at factors such as seizure frequency and the safety of the drug.
- A Phase 2 ‘Arcade’ trial that is planned to look at the effects of the drug in paediatric patients who have CDKL5 deficiency disorder (CDD) or Duplication 15q syndrome (Dup15q). In particular, the trial is designed to assess the frequency of motor seizures, and how safe and tolerable the drug is. This trial will be open-label and is expected to enrol a total of around thirty participants.
- An extension study called the ‘Endymion’ trial is open to patients who took part in a previous clinical study investigating the drug, and who have developmental and epileptic encephalopathies (DEEs).
These three trials are in addition to an on-going and fully enrolled Phase 1b/2a clinical trial for adult patients with DEEs. Topline data from this study is expected to become available in the fourth quarter of 2018.