EMERYVILLE, Calif., Sept. 08, 2016 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ: ZGNX ), a pharmaceutical company developing therapies for the treatment of orphan and central nervous system (CNS) disorders, today announced that the Company is sponsoring four poster presentations at the 12 th European Congress on Epileptology (ECE), taking place this week in Prague, Czech Republic. One poster will feature an update on the efficacy and safety data on ZX008 (low-dose fenfluramine) as an adjunctive therapy for seizures associated with Dravet syndrome from the new patient cohort included in the ongoing Belgian open-label study. This poster will primarily be an encore of the data that were presented in a podium presentation at the 14 th International Child Neurology Congress in May 2016.
The three burden of illness-related poster presentations will focus on better understanding the burden Dravet syndrome causes for the patient and their family, and also on identifying clinically relevant outcome measures to assess the impact on the lives of Dravet syndrome patients and their caregivers.
Once the last poster is presented, all four posters will be available here: http://www.zogenix.com/c/newsroom/publication...ations.php . “Our presence at ECE, and our collaborative research into the disease burden of Dravet syndrome, is indicative of Zogenix’s commitment to patients and their families affected by epilepsy,” said Stephen J. Farr, Ph.D., President and CEO. “Importantly, we remain encouraged by the continued meaningful reduction in seizure frequency and sustained cardiovascular safety being demonstrated in the ongoing Belgian open-label study. We are also dedicated to identifying the core clinically relevant quality of life-related outcome measures associated with this devastating condition to better reflect the impact treatments may have. In addition, our ZX008 Phase 3 program for Dravet syndrome continues to enroll patients in the U.S. and internationally, and Zogenix expects that the U.S. and European submissions for market authorization for ZX008 in Dravet syndrome will occur in 2017.”
ZX008 is designated as an orphan drug in both the U.S. and Europe, and also received Fast Track designation in the U.S., for the treatment of Dravet syndrome.
Zogenix at the 12 th European Congress on Epileptology
Title: Fenfluramine Significantly Reduces Seizure Frequency in Dravet Syndrome: A Prospective Study of a New Cohort of Patients Date: Tuesday 13th September 1:00-2:30 pm Poster Session #: P593
Title: Describing the Humanistic Burden of Illness in Dravet Syndrome – Important Questions Remain Date: Wednesday 14th September 1:00-2:30 pm Poster Session #: P283
Title: What areas of lives of caregivers of children with severe, refractory epilepsy are affected by caregiving? An expert panel report Date: Wednesday 14th September 1:00-2:30 pm Poster Session #: P214
Title: Towards a Composite Clinical Endpoint: Identifying a Core Set of Patient and Caregiver Relevant Outcome Measures Through Qualitative Research on the Global Impact of Dravet Syndrome Date: Wednesday 14th September 1:00-2:30 pm Poster Session #: P293
About the ZX008 Phase 3 Program The Zogenix study entitled, "A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) in Children and Young Adults With Dravet Syndrome," is being conducted for patients with Dravet syndrome whose seizures are not adequately controlled on their current seizure medication. For more information, please visit www.clinicaltrials.gov listing (NCT02682927).
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.
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 timing of the commencement of the second Phase 3 clinical study for ZX008 and ZX008’s potential as a treatment 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 the commencement, enrollment and completion of clinical trials; the potential that earlier clinical trials and studies 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, 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.
CONTACT: Investors: Andrew McDonald Founding Partner, LifeSci Advisors LLC 646-597-6987 | Andrew@lifesciadvisors.com
