Zogenix, Inc. announced on January 31st that the last patient has been randomized into the treatment period of Study 1504, its second Phase 3 clinical trial evaluating ZX008 (low-dose fenfluramine) as an adjunctive treatment for seizures in children and young adults with Dravet syndrome.
At the 71st American Epilepsy Society (AES) Annual Meeting in December, positive safety and efficacy data from the company’s Study 1 trial, exhibiting the drug’s ability to achieve a clinically meaningful benefit in the same indication, were presented.
Dravet syndrome is a pediatric epilepsy disorder in which a wide variety of seizure types plague the patient, and the condition is often associated with a high mortality rate. It typically begins in the first year of life of an otherwise healthy infant, and those affected can also experience developmental delays, and, at present, there aren’t any approved orphan drugs to treat the condition.
“The completion of patient randomization in Study 1504 represents another significant achievement in our ZX008 Phase 3 development program in Dravet syndrome,” said Stephen J. Farr, Ph.D., President and CEO of Zogenix in a press release. “We expect to announce top-line data from this study in the second quarter of this year. The data generated to date from the Phase 3 clinical program have further strengthened our confidence in the potential of ZX008 to become an important treatment option for the control of seizures in patients suffering from Dravet syndrome, a rare and catastrophic form of epilepsy.”