A year after Takeda tied up with Ovid Therapeutics to advance its epilepsy drug TAK-935, the pair is announcing two phase 2 trials in rare pediatric epilepsies and an extension trial for patients with developmental and epileptic encephalopathies (DEEs).
The companies partnered in 2017 to push the drug forward in Dravet and Lennox-Gastaut syndromes. Unlike the usual pharma/biotech deal under which Takeda might buy into a promising drug from Ovid, it was Ovid that signed on to help the Japanese pharma develop the drug, now known as TAK-935/OV-935. Takeda will lead work in Japan, with the option to do the same in Asia and other "selected geographies." Meanwhile, Ovid is taking charge of development and sales in the U.S., Europe, Canada and Israel.
One of the new trials, the phase 2 ARCADE pilot study, will test it in two additional pediatric epilepsies: CDKL5 deficiency disorder (CDD) or duplication 15q (Dup15q) syndrome. The placebo-controlled ELEKTRA trial will assess the drug in patients with Dravet syndrome or Lennox-Gastaut syndrome. Both studies will enroll patients aged two to 17 and will assess their frequency of seizures.
The third trial will involve patients with DEEs who participated in a previous trial. The primary objective of the two-year study is the long-term safety and tolerability of TAK-935/OV-935. DEE is an umbrella term for rare epilepsy conditions that tend to appear early in life and are associated with severe cognitive and developmental impairment, in addition to frequent treatment-resistant seizures throughout a patient's lifetime.
All three studies will kick off in the third quarter, Ovid said in a statement.
TAK-935/OV-935 is a selective inhibitor of CH24H, an enzyme that is predominantly expressed in the brain. Recent research suggests CH24H plays a role in the over-activation of the glutamatergic pathway. The neurotransmitter glutamate is linked to the initiation and spread of seizure activity and so, Ovid and Takeda believe that targeting CH24H could treat rare epilepsies by tamping down on glutamate hyperactivity.
“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," said Ovid CEO Jeremy Levin.
Patients with the X-linked disorder CDD or Dup15q syndrome present various symptoms, but the two conditions have seizures, developmental delay and intellectual disability in common. Treatment for both conditions focuses on managing symptoms and supporting the development of patients' skills.
Dravet and Lennox-Gastaut syndromes typically present in childhood, have a higher mortality rate than other types of epilepsy and are generally treatment-resistant. GW Pharma's cannabis-based Epidiolex earned the FDA nod in June for both Lennox-Gastaut and Dravet. However, GW will not be able to launch the drug in the U.S. until the Drug Enforcement Agency reschedules cannabidiol, the active ingredient in Epidiolex and a component of cannabis that does not have psychoactive properties.