ELEKTRA Trial Completes Enrollment to Test Soticlestat in Children With Dravet and LGS
The ELEKTRA clinical trial assessing the investigational oral therapy soticlestat (OV935/TAK-935) in children with Dravet syndrome and Lennox-Gastaut syndrome (LGS) has completed patient enrollment, Ovid Therapeutics recently announced.
“We completed enrollment significantly ahead of schedule in our placebo-controlled Phase 2 ELEKTRA trial in children with Dravet syndrome and Lennox-Gastaut syndrome, and as a result, we now expect data to be available in the third quarter of 2020,” Amit Rakhit, MD, president and chief medical officer of Ovid, said in a press release.
Soticlestat was developed by Takeda Pharmaceuticals in collaboration with Ovid Therapeutics for the treatment of rare developmental and epileptic encephalopathies, including Dravet and LGS.
The investigational therapy is a potent, highly-selective, first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase, which has a major role in clearing cholesterol in the brain. By blocking this enzyme, soticlestat is thought to reduce the activation of a neuronal signaling pathway — glutamatergic signaling via NMDA receptors — potentially reducing seizure susceptibility and improving seizure control in patients with Dravet, according to Ovid.
ELEKTRA (NCT03650452) is a multicenter study to assess the effectiveness and safety of soticlestat in 141 children and adolescents (2 to 17 years old) who have experienced seizures associated with Dravet (convulsive seizures) or LGS (drop or atonic seizures).
The study includes a four- to six-week observation period to establish seizure frequency, followed by a 20-week treatment period, divided into an eight-week dose optimization period followed by a 12-week maintenance period. The primary outcome of the study is the percent change in the frequency of seizures for 28 days after soticlestat treatment, compared to a placebo.
Patients who complete the ELEKTRA study will be able to enroll in the open-label, long-term Phase 2 ENDYMION (NCT03635073) trial.
Previous results from this ongoing study showed that in six adults with hard-to-treat epilepsies, including Dravet, who had rolled over from a Phase 1b/2a clinical study (NCT03166215), soticlestat led to a reduction in median seizure frequency of up to 90% and had a good safety profile.
Of note, the Phase 1b/2a trial found that soticlestat may have a drug-drug interaction with perampanel (sold under the brand Fycompa by Eisai), meaning that the two therapies should not be taken together. Data from this earlier study and the ENDYMION study suggest that the potential therapy is otherwise safe and well-tolerated.
“We are also pleased to report that all patients who have completed the ELEKTRA and ARCADE [NCT03694275] trials have rolled over into our ENDYMION open-label extension study,” Rakhit said.
The U.S. Food and Drug Administration granted orphan drug designation to soticlestat for the treatment of both Dravet syndrome and LGS in December 2017.
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