Zogenix Inc shares (NASDAQ:ZGNX) rocketed in the pre-market session after the biotech revealed that its drug to treat Dravet syndrome, a severe form of epilepsy, reduced the frequency of convulsive seizures that stem from the disease.
Before the opening bell, Zogenix shares jumped 19% to US$55.05 in response to the news.
Zogenix said that its Phase 3 study for its experimental drug ZX008 (low-dose flenfluramine hydrochloride) which treats children and young adults with Dravet syndrome successfully met its primary endpoint and all key secondary endpoints.
Indeed, patients in the study who took ZX008 reported a 54.7% reduction in mean monthly convulsive seizures compared to those who took a placebo.
“These impressive study results show the significant impact the addition of ZX008 made in reducing the burden of convulsive seizures for patients who are not adequately controlled using stiripentol, the standard of care for the treatment of Dravet syndrome in Europe,” said Dr. Rima Nabbout , an investigator for the study who works in the department of pediatric neurology with Necker Enfants Malades Hospital.
“If approved, ZX008 has the potential to be a transformative treatment for Dravet syndrome, a rare and serious form of epilepsy with few available treatment options,” she added.
ZX008 was also generally well-tolerated in this study, which evaluated 87 epileptic patients, ranging in age from 2 to 19.
A few of the most common side-effects endured were decreased appetite, diarrhea and fatigue.
The company is now set to submit applications for marketing approvals of the drug in both the US and Europe later this year.
ZX008 is already designated as an orphan drug in the US and Europe and has received recognition as a breakthrough therapy in the US for the treatment of Dravet syndrome.