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Zogenix, a pharmaceutical company developing therapies for the treatment of orphan and CNS disorders, has announced that the last patient has been randomized into the treatment period of Study 1, its first phase 3 clinical trial evaluating ZX008 (low-dose fenfluramine) as an adjunctive treatment for seizures in children and young adults with Dravet syndrome.
“The completion of patient randomization in Study 1 is an important milestone for our ZX008 phase 3 development program in Dravet syndrome,” said Stephen J. Farr, Ph.D, president and chief executive officer of Zogenix. “We look forward to the availability of top-line data from this study, which we expect in the third quarter of this year. We are grateful for the participation of the patients, their families and the investigators involved in our ongoing clinical programme.”
Study 1 is a three-arm, fixed-dose, placebo-controlled trial with 40 subjects per treatment group being conducted in the U.S., Canada, Europe, and Australia. Randomized subjects are titrated to their target dose (0.2 or 0.8 mg/kg/day ZX008, maximum of 30 mg/day, or placebo) over two weeks and then held at that fixed dose for 12 weeks of maintenance treatment. Subjects who complete Study 1 are eligible to enter a long-term, open-label extension study.
In addition to Study 1, Zogenix is conducting a second double-blind, randomized, two-arm pivotal phase 3 trial, Study 1504, in which all patients will be taking stiripentol, valproate and clobazam as part of their baseline standard care. In February 2017, the Company announced the initiation of the safety and efficacy portion of Study 1504, which compares a single dose of ZX008 versus placebo across the titration and 12-week maintenance periods. Study 1504 will enroll 40 subjects per treatment group.
Zogenix begins, treat dravet syndrome
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