Clinical Trials

Date: 2017-08-21

Type of information: Treatment of the first patient

phase: 1b/2a

Announcement: treatment of the first patient

Company: Ovid Therapeutics (USA - NY)

Product: TAK-935/OV935

Action mechanism:

enzyme inhibitor/CH24H inhibitor. TAK-935/OV935 is a first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase - CH24H). This enzyme is predominantly expressed in the brain, it converts cholesterol to 24-S-hydroxycholesterol which then exits the brain into the blood plasma circulation. TAK-935/OV935 is believed to modulate the N-Methyl-D-Aspartate (NMDA) receptor, which has been implicated in several neurologic disorders, including rare epilepsies. It has completed four Phase 1 clinical studies which have assessed tolerability and target engagement at doses which are believed to be therapeutically relevant.
TAK-935/OV935 is being co-developed by Ovid and Takeda Pharmaceutical. The companies formed a global collaboration focused on the clinical development and commercialization of TAK-935/OV935 in January 2017.

Disease: developmental and/or epileptic encephalopathies, including Dravet Syndrome, Lennox-Gastaut Syndrome and Tuberous Sclerosis Complex

Therapeutic area: Neurological diseases - CNS diseases - Neurodevelopmental diseases

Country:

Trial details:

The randomized, double-blind, placebo-controlled, dose-escalation Phase 1b/2a clinical trial will enroll approximately 20 adult patients with developmental and/or epileptic encephalopathies, including Dravet Syndrome, Lennox-Gastaut Syndrome and Tuberous Sclerosis Complex. The multicenter trial will include an initial one-month baseline period followed by a one-month double-blind, dose-escalation phase. Participants will have the option to continue for an additional two-month open-label extension phase. The primary endpoint of the study is to characterize the safety and tolerability of TAK-935/OV935. Secondary endpoints include assessment of standard safety laboratory values and evaluation of pharmacokinetics.

Latest news:

• On August 21, 2017, Ovid Therapeutics announced it has randomized the first patient in its Phase 1b/2a clinical trial of TAK-935, also known as OV935, in collaboration with Takeda Pharmaceutical Company Limited. This marks the second program Ovid has advanced into Phase 2 clinical development this year. The trial will enroll approximately 20 adult patients with developmental and/or epileptic encephalopathies, including Dravet Syndrome, Lennox-Gastaut Syndrome and Tuberous Sclerosis Complex.
Data from the Phase 1b/2a trial in adults with developmental and/or epileptic encephalopathies, which are types of rare epilepsies that share similar clinical manifestations, is anticipated in 2018.
As part of the broader development program, Ovid and Takeda also plan to study the role of 24-S-hydroxycholesterol (24HC) as a peripheral biomarker that can inform future clinical trial designs and help clinicians individualize the use of this therapy.