Ovid Therapeutics has begun patient randomisation in a Phase Ib/IIa clinical trial of TAK-935 (OV935) to treat adults with rare epilepsies.

TAK-935 is a potent highly selective inhibitor of cholesterol 24-hydroxylase (CH24H) currently being developed in collaboration with Takeda Pharmaceutical.

The randomised, double-blind, multi-centre, placebo-controlled, dose-escalation Phase Ib/IIa trial will evaluate the drug candidate in around 20 subjects with developmental and / or epileptic encephalopathies such as Dravet Syndrome, Lennox-Gastaut Syndrome and Tuberous Sclerosis Complex.

Ovid Therapeutics chief medical and portfolio management officer Amit Rakhit said: “We believe that TAK-935 / OV935 has the potential to target the increased pro-epileptic signalling that occurs in developmental and / or epileptic encephalopathies and provide a treatment for people with rare epilepsies who currently do not have sufficient options.

“This trial is the beginning of a planned broader development programme for TAK-935 / OV935.”

"This trial is the beginning of a planned broader development programme for TAK-935 / OV935."

The trial will initially include a one-month baseline period and a subsequent one-month double-blind dose escalation phase, and the subjects could also participate in an additional two-month open-label extension phase.

The trial’s primary endpoint is safety and tolerability, while secondary endpoints comprise evaluation of standard safety laboratory values and evaluation of pharmacokinetics.

Ovid Therapeutics expects that the results from this Phase Ib/IIa trial will be available next year.

Upon assessment of TAK-935 in four previous Phase I trials with 86 healthy volunteers, it was observed to be well-tolerated without clinically significant safety findings.

Additionally, Ovid and Takeda intend to investigate 24-S-hydroxycholesterol (24HC) as a peripheral biomarker to aid the design of clinical trials and individualisation of therapy.