ZX008 meets Phase III goals in Dravet syndrome trial

US CNS focused biotech firm Zogenix (Nasdaq: ZGNX) saw its shares almost triple in value on Friday after the company said that a late-stage trial of a treatment for a rare type of epilepsy met its main goal.

Zogenix reported positive top-line results from its first Phase III trial (Study 1) for its investigational drug, ZX008 (low-dose fenfluramine hydrochloride), for the treatment of Dravet syndrome. The trial met its primary objective of demonstrating that ZX008, at a dose of 0.8mg/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 six-week baseline observation period and the 14-week treatment period (p<0.001). ZX008 0.8mg/kg/day also demonstrated 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 0.2mg/kg/day ZX008 dose versus placebo also demonstrated statistically significant improvement compared with placebo.

The stock closed up 172.2% at $35.05 on Friday, having skyrocketing by 184% to $36.50 in Friday’s pre-market trading.