A drug under development for rare forms of epilepsy has shown an ability to reduce the frequency of seizures, according to two clinical studies.
New York-based Ovid Therapeutics said Wednesday that results from ARCADE, its Phase II pilot study of the drug soticlestat, and the ENDYMION study showed reduced frequency of seizures over time in patients with CDKL5 deficiency disorder, or CDD, and Dup15q syndrome, two rare forms of epilepsy.
The two studies included 12 patients with CDD and eight with Dup15q, both of which are highly refractory rare types of epilepsy that have no approved treatment options. ARCADE is an open-label signal-finding pilot study, while ENDYMION is a long-term extension study. Ovid is developing soticlestat, a cholesterol 24-hydroxylase inhibitor, in a partnership with Japanese drugmaker Takeda Pharmaceutical.
The data from the two studies showed that in CDD, there was a median reduction in motor seizure frequency by 24% during the 12-week maintenance period in ARCADE, which in ENDYMION increased to a 50% reduction among the five patients who were treated for nine months. In Dup15q, ARCADE showed an increase in the median frequency of motor seizures during the 12-week maintenance period, but longer-term data on four Dup15q patients treated continuously for nine months showed a reduction by 74%.
“Anti-epileptic drugs can lose efficacy over time,” said Dr. Scott Demarest, assistant professor of pediatrics and neurology at the University of Colorado, in a statement on behalf of Ovid. “Soticlestat may produce acute and long-term antiseizure effects in addition to potential improvements outside of motor seizure frequency reduction, as suggested by clinical global impression scales.”
Soticlestat, also known as OV935 and TAK-935, is additionally in Phase II development for Dravet syndrome, another severe form of epilepsy, as well as Lennox-Gastaut syndrome.
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