Zogenix Inc. (NASDAQ: ZGNX) shares skyrocketed, as they more than doubled during premarket. On Friday’s premarket, Zogenix shares were up almost 150 percent above Thursday’s close at $12.88.
Zogenix reported positive-top line results from its first Phase 3 trial for its drug, ZX008, for the treatment of Dravet syndrome. The clinical trial met its primary objectives of demonstrating at a dose of 0.8mg/kg/day is far more superior than a therapy treatment in young adults and infants. The test was based off the frequency of convulsive seizures between a 6 week observation period and a 14 week treatment period.
Dravet syndrome is a rare, but very catastrophic form of epilepsy. The symptoms usually show signs of prolonged and frequent seizures. It affects approximately 1 in every 15,000 in infants and young adults.
“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.” Joseph Sullivan M.D., director of the Pediatric Epilepsy Center in UCSF Benioff Children’s Hospital San Francisco, and Principal Investigator of Study 1 in the U.S.
In the clinical trial, patients taking ZX008 0.8 mg/kg/day achieved a 63.9 percent reduction in mean monthly convulsive seizures compared to placebo. The median percent reduction in monthly convulsive seizure frequency was 72.4 percent among ZX008 0.8 mg/kg/day patients compared to 17.4 percent in placebo patients.
“We are extremely pleased with the top-line efficacy and safety results from Study 1 which reinforce the potential of ZX008 to be an important new treatment for seizure control in children with Dravet syndrome. We look forward to presenting further data in future publications and at medical conferences,” said Stephen J. Farr, Ph.D., President and CEO of Zogenix.
The company expects even better results in the second pivotal Phase 3 trial, which is expected to begin in the first half of 2018. The company is also on track to submit its applications for regulatory approvals in the U.S. and Europe by the second half of 2018 as well.