Zogenix Announces Initiation of Clinical Efficacy Portion of Study 1504 for ZX008 in Dravet Syndrome
Study 1504 Part of Phase 3
Safety and Efficacy Portion of Study Expanded from EU to Include Sites in U.S. and
The primary purpose of Cohort 1 was to identify the appropriate ZX008 dose to then be used in Cohort 2, since the combination of stiripentol and clobazam is expected to impact fenfluramine pharmacokinetics through the inhibition of enzymes responsible for fenfluramine’s metabolism. Based on the outcome of the completed pharmacokinetic analysis from Cohort 1, the dose of ZX008 being utilized in Cohort 2 is 0.5 milligrams per kilogram per day, which results in equivalent steady-state exposure to a dose of 0.8 milligrams per kilogram per day in patients whose background medications do not include the combination of stiripentol and clobazam. This dose (0.8 mg/kg/day) is the high dose of ZX008 currently being evaluated in Studies 1501 and 1502, which are two identical ongoing double-blind randomized placebo-controlled studies that are also being conducted as part of Zogenix’s Phase 3 program for ZX008 in patients with Dravet syndrome. The two treatment groups in Cohort 2 of Study 1504 will have either ZX008 or placebo added to their stable stiripentol drug regimen. The duration of maintenance treatment is 12 weeks, the same duration as in Studies 1501 and 1502, and the seizure endpoints are also the same, including the primary outcome measure of change from baseline in frequency of convulsive seizures.
Study 1504 was initially to be conducted only in
“We are pleased to initiate the efficacy and safety portion of this important Phase 3 study,” said Professor
“The initiation of the efficacy portion of Study 1504 represents another key milestone in Zogenix’s ZX008 Dravet syndrome Phase 3 program,” said
“We are excited to have the opportunity to participate in this study in the U.S.,” said
For more information, visit www.zogenix.com.
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