Zogenix’s seizure drug clears late-stage trial, shares soar
(Reuters) – Zogenix Inc (ZGNX.O) said on Thursday its drug to treat a rare form of childhood epilepsy reduced convulsive seizures in a second late-stage trial, sending the drug developer’s shares up as much as 26 percent.
The successful trial takes the company one step closer to bringing the drug to the market, and comes close on the heels of regulatory approval for GW Pharmaceuticals Plc’s (GWPH.O) cannabis-based treatment for the same form of epilepsy.
Current treatment options for Dravet syndrome, which affects an estimated 20,000 patients in the United States, are limited to a combination of seizure medication and drugs to prevent emergencies.
Zogenix’s drug uses a low-dose, liquid solution of fenfluramine, which was used in the now off-the-market “fen-phen” obesity drug combination. The treatment was pulled off the market due to evidence of heart valve damage.
But Zogenix said no safety signal of any cardiovascular abnormality had been identified to date in any of the trials of the drug.
In the trial, the treatment reduced the frequency of convulsive seizures by 62.7 percent on median, compared with a 1.2 percent reduction in patients taking placebo, meeting the main goal of the trial.
“We are encouraged by that (strength of seizure reduction data) and believe our drug will be used fairly early during treatment,” Chief Executive Officer Stephen Farr said on a call with analysts.
Zogenix said it would now focus on submitting applications for marketing approval of its drug in the United States and Europe in the fourth quarter of 2018.
GW’s treatment is not yet on the market as the company awaits action from the Drug Enforcement Administration. It expects the drug to be available to patients by fall 2018.
GW’s Nasdaq-listed shares were down slightly at $140.05 in early trading.
Zogenix is also conducting a study to see if its drug can be safely taken along with GW’s treatment.
The company said last September that the treatment met the main goal of the first late-stage study of the drug.
Zogenix’s shares rose were up 18 percent at $54.30 in early trading on Thursday after hitting a record high of $58.30.
Reporting by Manas Mishra; Editing by Saumyadeb Chakrabarty