Zogenix, Inc. (NASDAQ: ZGNX) shares rose sharply Thursday, after the company disclosed top-line results from second Pivotal Phase 3 trial of ZX008 in dravet syndrome. The company reported that the trial met primary endpoint.
The company, based in Emeryville, California, is a pharmaceutical company developing therapies for the treatment of rare central nervous system (CNS) disorders, today reported positive top-line results from its second confirmatory Phase 3 study for its investigational drug, ZX008 (low-dose fenfluramine hydrochloride), for the treatment of children and young adults with Dravet syndrome.
The study results, which are consistent with those reported in Study 1, Zogenix’s first pivotal Phase 3 study, successfully met the primary endpoint and all key secondary endpoints, demonstrating that ZX008, at a dose of 0.5 mg/kg/day (maximum 20 mg/day), is superior to placebo when added to a stiripentol regimen.
Patients taking ZX008 achieved a 54.7% greater reduction in mean monthly convulsive seizures compared to placebo. The median reduction in monthly convulsive seizure frequency was 62.7% in the ZX008 group compared to 1.2% in placebo patients.
Said Professor Rima Nabbout "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."
Zogenix is dedicated to developing therapies for people living with severe central nervous system disorders who have limited or no treatment options.
Shares climbed $8.75, or 18.9%, to $55.05
