Blog Coverage Zogenix Announces Completion of Enrollment for the Phase III Trial in Dravet Syndrome
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LONDON, UK / ACCESSWIRE / May 1, 2017 / Active Wall St. blog coverage looks at the headline from Zogenix, Inc. (NASDAQ: ZGNX) as the Company announced on April 27, 2017, 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. Register with us now for your free membership and blog access at:
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Zogenix' Study 1 is a three-arm, fixed-dose, placebo-controlled trial with 40 subjects per treatment group being conducted in the US, 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.
"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 CEO 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 program."
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.
Dravet Syndrome
Dravet syndrome is a rare, catastrophic, lifelong form of epilepsy that begins in the first year of life with frequent and/or prolonged seizures. Previously known as Severe Myoclonic Epilepsy of Infancy (SMEI), it affects 1: 15,700 individuals, 80% of whom have a mutation in their SCN1A gene. Common issues associated with Dravet syndrome include, Prolonged seizures, Behavioral and developmental delays, Movement and balance issues, Orthopaedic conditions, Sleeping difficulties, Chronic infections, Sensory integration disorders and Disruptions of the autonomic nervous system.
Patients with Dravet syndrome face a 15%-20% mortality rate due to SUDEP (Sudden Unexpected Death in Epilepsy), prolonged seizures, seizure-related accidents such as drowning, and infections.
Stock Performance
At the closing bell, on Friday, April 28, 2017, Zogenix's stock ended the trading session flat at $11.00. A total volume of 145.01 thousand shares were traded at the end of the day. In the last three months and previous six months, shares of the Company have advanced 36.65% and 28.65%, respectively. Moreover, the stock gained 3.48% in the last twelve months. At Friday's closing price, the stock's net capitalization stands at $272.91 million.
Earnings Alert: Zogenix announced that it will report its financial results for the first quarter ended March 31, 2017, after the market close, and will host a corporate update conference call and webcast on May 04, 2017 at 4:30 PM ET.
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