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Zogenix Announces Initiation of Multi-National Phase 3 Clinical Trial for ZX008 in Dravet Syndrome

EMERYVILLE, Calif., June 07, 2016 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing therapies for the treatment of central nervous system (CNS) disorders, today announced the initiation of the second Phase 3 clinical trial, a multi-national study (Study 1502), for the Company’s lead product candidate, ZX008, as an adjunctive treatment of seizures in children with Dravet syndrome. ZX008 is designated as an orphan drug in both the U.S. and Europe, and received Fast Track designation in the U.S., for the treatment of Dravet syndrome.

“We are excited to begin this clinical trial, as we view ZX008 as an important potential new treatment option for children and adolescents with Dravet syndrome,” said Lieven Lagae, M.D., Ph.D., Professor at the University of Leuven, Belgium (KUL), Head of the Paediatric Neurology Department of the KUL University Hospitals and Director of the Childhood Epilepsy Program at the KUL University Hospitals, and Principal Investigator of the Multi-National ZX008 trial. “This is a devastating epilepsy syndrome and a severely under-served patient population. The open-label clinical data generated to date for ZX008 have been compelling and we look forward to conducting this Phase 3 clinical trial.”

The Phase 3 program for ZX008 includes two randomized, double-blind placebo-controlled studies investigating two dose levels of ZX008 (0.2 mg/kg/day and 0.8 mg/kg/day, up to a maximum daily dose of 30 mg), as well as placebo. Zogenix intends to enroll 105 subjects in each of the two studies, with 35 patients in each treatment arm. The primary endpoint of both studies is the change in frequency of convulsive seizures as compared to placebo. The key secondary endpoints include 40% and 50% responder analyses, which are important for European regulatory submissions, and the convulsive seizure free interval, which is of significant interest to parents and to patients. The first Phase 3 clinical trial, Study 1501, is currently enrolling patients at sites throughout North America.

“The initiation of Study 1502, which will take place at sites in Western Europe and Australia, represents a significant milestone for Zogenix and our development of ZX008,” said Gail M. Farfel, Ph.D., Chief Development Officer of Zogenix. “We are encouraged by the sustained effectiveness and cardiovascular-related safety data, as well as high levels of sleep quality and quality of life, generated to date for ZX008 in Dravet syndrome in the ongoing open-label study in Belgium.”

About Zogenix

Zogenix, Inc. (Nasdaq:ZGNX) is a pharmaceutical company committed to developing and commercializing CNS therapies that address specific clinical needs for people living with orphan and other CNS disorders who need innovative treatment alternatives to improve their daily functioning.

About Dravet Syndrome

Dravet syndrome (also known as Severe Myoclonic Epilepsy of Infancy) is a rare, severe and therapy-resistant form of epilepsy most often caused by an identifiable gene defect that results in abnormal functioning of a sodium channel in the brain. Children with Dravet syndrome experience severe, long-lasting, fever-related seizures in the first year of life. Other seizures typically arise later, including myoclonus (involuntary muscle spasms) and status epilepticus (prolonged seizures), which often result in severe cognitive and developmental impairment. Episodes of status epilepticus require immediate emergency care and can be fatal.

Individuals with Dravet syndrome face a higher incidence of SUDEP (sudden unexplained death in epilepsy) and have associated conditions, which also require proper treatment and management. Children with Dravet syndrome do not outgrow this condition and it affects every aspect of their daily lives.

Forward Looking Statements

Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed" and similar expressions are intended to identify forward-looking statements. These statements are based on the company's current beliefs and expectations. These forward-looking statements include statements regarding subject enrollment in the Phase 3 clinical studies for ZX008 and ZX008’s potential as a treatment option for seizures associated with Dravet syndrome. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: the uncertainties associated with the clinical development and regulatory approval of product candidates such as ZX008, including potential delays in enrollment and completion of clinical trials; the potential that earlier clinical trials may not be predictive of future results; Zogenix's reliance on third parties to conduct its clinical trials, enroll patients, manufacture its preclinical and clinical drug supplies and manufacture commercial supplies of its drug products, if approved; unexpected adverse side effects or inadequate therapeutic efficacy of ZX008 that could limit approval and/or commercialization, or that could result in recalls or product liability claims; Zogenix's ability to fully comply with numerous federal, state and local laws and regulatory requirements that apply to its product development activities; Fast Track designation may not result in an expedited regulatory review process; and other risks described in Zogenix’s prior press releases as well as in public periodic filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

Source: Zogenix, Inc.

Posted: June 2016

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