Zogenix, a NASDAQ-listed pharmaceutical company developing therapies for the treatment of rare central nervous system (CNS) disorders, has randomized the last patient into second Phase 3 clinical double-blind trial testing ZX008 (low-dose fenfluramine) as an adjunctive treatment for seizures in children and young adults with Dravet syndrome.
Previously, in the third quarter of 2017, the Company announced positive top-line data from its first global Phase 3 trial of ZX008, Study 1, that met the primary efficacy endpoint, as well as all prespecified key secondary efficacy endpoints, Zogenix said.
In a press release issued Wednesday, Stephen J. Farr, President and CEO of Zogenix said: “The completion of patient randomization in Study 1504 represents another significant achievement in our ZX008 Phase 3 development program in Dravet syndrome. We expect to announce top-line data from this study in the second quarter of this year. The data generated to date from the Phase 3 clinical program have further strengthened our confidence in the potential of ZX008 to become an important treatment option for the control of seizures in patients suffering from Dravet syndrome, a rare and catastrophic form of epilepsy.”
Study 1504 with approximately 40 subjects per treatment group is being conducted in the U.S., France, Spain, the Netherlands, U.K., Canada, and Germany, in which all subjects are taking stiripentol as part of their baseline standard of care.
ZX008 has received orphan drug designation in the USA and Europe.