Takeda Pharma Says Phase 2 ELEKTRA Study Of Soticlestat Met Primary Endpoint

(RTTNews) - Japanese drug maker Takeda Pharmaceutical Co. Limited (TAK) and biopharmaceutical company Ovid Therapeutics Inc. (OVID) said that the randomized Phase 2 ELEKTRA study of Soticlestat in children with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS) met the primary endpoint of reducing seizure frequency in the children.

Soticlestat (TAK-935/OV935) is a highly selective, oral, first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase (CH24H). It is being investigated by Ovid and Takeda for the treatment of rare developmental and epileptic encephalopathies or DEEs, a group of highly refractory epilepsy syndromes including DS and LGS.

The companies noted that ELEKTRA study achieved its primary endpoint with high statistical significance, demonstrating a 27.8 percent median reduction from baseline in convulsive seizure (DS) and drop seizure (LGS) frequency, compared to a 3.1 percent median increase in patients taking placebo during the 12-week maintenance period.

In addition, DS and LGS patients treated with soticlestat showed a 29.8 percent median reduction in convulsive seizure (DS) and drop seizure (LGS) frequency, compared to 0.0 percent change in median seizure frequency in patients taking placebo during the full 20-week treatment period.

"We look forward to continuing our collaboration with Takeda to initiate a Phase 3 registrational program for soticlestat in patients with DS, while continuing to analyze the data from patients with LGS in the ELEKTRA and ENDYMION studies to define potential next steps. We also expect to report data from the open-label Phase 2 ARCADE study with soticlestat in patients with CDKL5 deficiency disorder and Dup15q syndrome, two other types of highly-refractory DEEs, later this quarter," said Amit Rakhit, President and Chief Medical Officer of Ovid.

ELEKTRA was an international, multi-center, randomized, double-blind, placebo-controlled study designed to evaluate treatment with soticlestat in pediatric patients, aged 2 to 17 years, with highly refractory epileptic seizures associated with DS (convulsive seizures) or LGS (drop seizures).

The study consisted of a four- to six-week screening period to establish baseline seizure frequency, followed by a 20-week double-blind treatment period, including an 8-week dose optimization period and a 12-week maintenance period.

During the 8-week dose optimization period, patients were titrated from 100mg twice daily or BID, to 200mg BID to 300mg BID of orally administered soticlestat.