Zogenix Announces Initiation of Phase 3 Trial for ZX008 in Lennox-Gastaut Syndrome
“LGS is a rare, devastating form of epilepsy that disrupts the lives of patients and their families, who are usually unable to control their seizures despite treatment with a number of existing therapeutic options,” said Associate Professor
The Phase 3 multicenter, global LGS trial is divided in two parts. Part 1 is a double-blind, placebo-controlled investigation to assess the safety, tolerability and efficacy of ZX008, low-dose fenfluramine, when added to a patient’s current anti-epileptic therapy. The trial will include two dose levels of ZX008 (0.2 mg/kg/day and 0.8 mg/kg/day, up to a maximum daily dose of 30 mg), as well as placebo. After establishing baseline seizure frequency for 4 weeks, randomized patients will be titrated to their dose over a 2-week titration period, followed by a 12-week fixed dose maintenance period. Zogenix is targeting a total of 225 patients (75 per treatment arm) in the trial. The primary endpoint of the clinical trial is change in the number of seizures that result in drops between baseline and the combined titration and maintenance periods at the 0.8 mg/kg/day dose. The key secondary endpoints include change in the number of seizures that result in drops between baseline and the combined titration and maintenance periods at the 0.2 mg/kg/day dose, and the proportion of patients achieving a 50 percent reduction in drop seizures. Part 2 of the clinical trial will be a 12-month open-label extension to evaluate the long-term safety, tolerability and effectiveness of ZX008.
The initiation of this Phase 3 program follows a Phase 2 open-label, dose-finding investigator-initiated clinical trial of ZX008 for the treatment of LGS that was conducted by Lieven Lagae, M.D., Ph.D., Professor at the University of Leuven, Belgium, Head of the Pediatric Neurology Department. The interim Phase 2 results were presented at the 70th Annual Meeting of the
“Following the recent positive top-line results from our first Phase 3 clinical trial for ZX008 in Dravet syndrome, the initiation of this Phase 3 program in LGS represents another important clinical milestone for our ZX008 development program in intractable childhood-onset epilepsy syndromes,” said
ZX008 for the treatment of LGS has previously been designated as an orphan drug by both the
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Source: Zogenix, Inc.