Zogenix Completes Enrollment in Second ZX008 Phase 3 Clinical Trial in Dravet Syndrome
Study 1504 Top-Line Data on Track for 2Q 2018
“The completion of patient randomization in Study 1504 represents another significant achievement in our ZX008 Phase 3 development program in Dravet syndrome,” said
Study 1504 is a double-blind, randomized, two arm Phase 3 trial with approximately 40 subjects per treatment group being conducted in the U.S.,
Study 1 results were announced in fall 2017. The trial met its primary objective of demonstrating that ZX008, at a dose of 0.8 mg/kg/day, is superior to placebo as adjunctive therapy in the treatment of Dravet syndrome in children and young adults based on change in the frequency of convulsive seizures between the 6-week baseline observation period and the 14-week treatment period (p<0.001). ZX008 0.8 mg/kg/day also achieved statistically significant improvements versus placebo in all key secondary measures, including the proportion of patients with clinically meaningful reductions in seizure frequency and longest seizure-free interval. The same analyses comparing a 0.2 mg/kg/day ZX008 dose versus placebo also demonstrated significant improvement compared with placebo. Both doses of ZX008 were safe and well-tolerated during the study, and most adverse events were mild or moderate in severity, and consistent with the known profile of the compound.
ZX008 is designated as an orphan drug in both the U.S. and
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Source: Zogenix, Inc.