Findings Presented by Zogenix at the NORD Rare Diseases and Orphan Products Breakthrough Summit in Washington, D.C.
EMERYVILLE, Calif., Oct. 16, 2017 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a pharmaceutical company developing therapies for the treatment of rare central nervous system (CNS) disorders, today announced interim results of the Sibling Voices Survey, which was developed by Zogenix to evaluate the psychosocial impact on the siblings of patients with severe childhood epilepsies, including Dravet syndrome and Lennox-Gastaut syndrome (LGS). The survey was conducted in collaboration with Lauren Schwartz, Ph.D., of the University of Washington, Department of Rehabilitation Medicine, and the results were presented at the National Organization for Rare Disorders (NORD) and Orphan Products Breakthrough Summit, taking place October 16-17, 2017, in Washington, D.C.
“In a recently conducted survey by the Dravet Syndrome Foundation, 74 percent of caregivers expressed concerns about the emotional impact on siblings of children with Dravet syndrome, and the interim results from the Sibling Voices Survey are a significant advancement in our understanding of the far-reaching implications that severe childhood epilepsies have on the lives of siblings and loved ones,” said Nicole Villas, President & Scientific Director of the Dravet Syndrome Foundation Board of Directors. “We are optimistic that the insights gained from the Sibling Voices Survey will assist in the development of tools to help families, and we are grateful for Zogenix’s dedication to addressing the unmet needs of this patient community.”
To date, there have been 183 total respondents to the Sibling Voices survey; this interim analysis focuses on the 27 youngest respondents (< 18 years old). Of siblings aged 9-12 years old, two-thirds reported feeling worried or scared when their sibling has a seizure and the majority (83 percent) feel easily scared and fearful their sibling will die. Siblings in the 13-17 years old range reported concerns over their parents being stressed and/or unhappy (60 percent) and over half (53 percent) reported feeling irritable and/or easily frustrated. Many of these same group of children (73 percent) stated they had been talked to about the possibility of their sibling with severe epilepsy dying and indicated feeling stressed and worried by this possibility (43 percent).
“The broader impact of severe childhood epilepsies on the entire family, and in particular to siblings, is an area of major concern expressed by many caregivers,” said Bradley Galer, M.D., Zogenix’s Executive Vice President and Chief Medical Officer. “To our knowledge, this study represents the first-of-its-kind research to quantify how having a child with severe epilepsy in the household affects other siblings. This is an essential step towards the creation of important resources for families in this difficult situation.”
Zogenix is currently conducting a Phase 3 clinical program in the U.S. and internationally of its investigational therapy, ZX008, for the treatment of Dravet syndrome. The Company recently reported positive top-line results from its first Phase 3 trial (Study 1) in this Phase 3 program. ZX008 for the treatment of Dravet syndrome has orphan designation in both the U.S. and Europe, and the development program has received Fast Track designation in the U.S. Zogenix intends to initiate a Phase 3 clinical trial for ZX008 in LGS before the end of 2017. ZX008 was recently designated as an orphan drug for the treatment of LGS.
Zogenix (Nasdaq:ZGNX) is focused on developing therapies for patients with rare central nervous system (CNS) conditions that have limited or no treatment options but face a critical need. For more information, visit www.zogenix.com.
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 the conduct of the Phase 3 clinical program of ZX008 for the treatment of Dravet syndrome; and the timing of initiation of a Phase 3 clinical trial in Lennox-Gastaut 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 the commencement, enrollment and completion of clinical trials; 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, as well as rules and regulations outside the United States, 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.
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Source: Zogenix, Inc.