Shares of Zogenix, Inc. ZGNX traded higher by 200 percent early Friday morning after the company announced top-line results from a phase 3 clinical trial exploring its drug called ZX008 for the treatment of Dravet syndrome.
Zogenix said that its trial met its primary objective of demonstrating that ZX008, when given to patients at a dose of 0.8 mg/kg/day, is superior to a 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 six-week baseline observation period and the 14-week treatment period.
ZX008 at 0.8 mg/kg/day also showed statistically significant improvements versus a placebo in all key secondary measures, including the proportion of patients with clinically meaningful reductions in seizure frequency and longest seizure-free interval, according to the company.
Zogenix's results appear to look "strong," Stat News' Adam Feuerstein, a notable biotech expert, commented in a Tweet.
"Dravet syndrome is a rare, but catastrophic form of epilepsy that can be devastating for patients and their families," said Dr. Joseph Sullivan, director of the Pediatric Epilepsy Center in UCSF Benioff Children's Hospital San Francisco, and principal investigator of Study 1 in the U.S. "These results are truly exciting and demonstrate, in a large multicenter controlled trial, the impressive efficacy of low-dose fenfluramine for patients with Dravet syndrome. If approved, ZX008 could play an important role in treating this devastating condition."
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