Today, there are hundreds of thousands of people struggling with different rare neurological diseases. This is what pushed Ovid Therapeutics Inc (NASDAQ:OVID) into initiating a study that would bring forth a potential treatment for soticlestat in children with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS). The results of the randomized Phase 2 ELEKTRA study are reportedly topline. They have met the primary endpoint demonstrating the ability to reduce seizure frequency in the children.
Soticlestat’s Safety Profile was Consistent with those of Previous Studies
Pediatric patients, aged 2 to 17 years, were the ELEKTRA study’s primary targets, which enrolled 141 patients, but 126 completed the study. The subjects had to be suffering from highly refractory epileptic seizures. The study was to first establish baseline seizure frequency across a four- to six-week screening period. A 20-week double-blind treatment period followed an 8-week dose optimization period and, finally, a 12-week maintenance period.
The primary endpoint pointed out a high statistical significance of a 27.8% median reduction in convulsive seizure (DS).
This was in comparison to a 3.1% median increase in patients taking placebo. The general observation from Soticlestat’s Safety Profile is that it was tolerable. There were no new safety indicators identified.
The Need for more Options to Manage Treatment-resistant Seizures
Patients suffering from epileptic encephalopathies like DS and LGS have very difficult lives. This is according to a child neurologist, Cecil Hahn, from The Hospital for Sick Children. Nonetheless, the promising results are something worth looking up to. However, the associate professor of pediatrics says that this should not be considered to be enough. As DS and LGS become more common, there is a need for more options for managing treatment-resistant seizures.
Meanwhile, it was mentioned that the success of the Phase 2 ELEKTRA study of soticlestat was not solely dependent on Ovid Therapeutics Inc. There was a collaboration with Takeda Pharmaceutical a Japanese drugmaker. The chief medical officer, Ovid, Amit Rakhit, says that the collaboration was worth it, and they have all reasons to look forward to a new one. Takeda is looking forward to initiating a Phase 3 registrational program for soticlestat in patients with DS.