Full Results from Second Pivotal Phase 3 Trial of FINTEPLA® (ZX008) in Dravet Syndrome (Study 1504)
New Long-Term Efficacy and Safety Data from Open-Label Extension Trial (Study 1503)
Studies on the Impact of Severe Epilepsy on Quality of Life for Patients and Families
EMERYVILLE, Calif., Nov. 26, 2018 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ: ZGNX), a pharmaceutical company developing therapies for the treatment of rare diseases, today announced that data from nine abstracts, including four “late-breakers,” will be presented at the 72nd American Epilepsy Society (AES) Annual Meeting taking place in New Orleans from November 30 – December 4, 2018. The Zogenix-sponsored presentations will include new clinical data from the second pivotal Phase 3 study, data on the long-term efficacy and safety of FINTEPLA® (ZX008) in Dravet syndrome, along with data further demonstrating the significant burden that living with severe childhood onset epilepsy has on children, caregivers and family members.
In addition to the posters, Zogenix will host a Scientific Exhibit Room on Sunday, December 2 from 8:00 am – 11:00 am CT. Zogenix study investigators and authors will be present to discuss the posters in more detail and answer questions.
Below is an overview of the presentations.
| Fenfluramine HCl (Fintepla®) Provides Long-Term Clinically Meaningful Reduction in Seizure Frequency: Results of an Open-Label Extension Study |
| Presented by: Lieven Lagae M.D., Ph.D., University Hospital Leuven, Leuven, Belgium |
| Poster Session #: 3.463 |
| Monday, December 3, 12:00 – 2:00 pm CT |
| Long-Term Cardiovascular Safety of Fenfluramine HCl (Fintepla®) in the Treatment of Dravet Syndrome: Interim Analysis of an Open-Label Safety Extension Study |
| Presented by: Anupam Agarwal, M.D., Zogenix, Inc., Emeryville, CA on behalf of Wyman Lai, M.D., Children’s Hospital of Orange County Heart Institute, Orange, CA |
| Poster Session #: 3.453 |
| Monday, December 3, 12:00 – 2:00 pm CT |
| Fenfluramine (Fintepla®) Reduces Convulsive Seizure Frequency in Dravet Syndrome Patients Receiving an Antiepileptic Drug Treatment Regimen Containing Stiripentol: A Phase 3, Randomized, Placebo-Controlled Clinical Trial |
| Presented by: Rima Nabbout M.D., Ph.D., Necker Enfants Malades Hospital, Paris, France |
| Poster Session #: 3.461 |
| Monday, December 3, 12:00 – 2:00 pm CT |
| What Defines “Clinical Meaningful Changes in Seizure Frequency?” Analysis of Data From a Phase 3 Clinical Trial of ZX008 in Dravet Syndrome |
| Presented by: Arnold Gammaitoni, Pharm. D., Zogenix, Inc., Emeryville, CA on behalf of Rima Nabbout M.D., Ph.D., Necker Enfants Malades Hospital, Paris, France |
| Poster Session #: 3.202 |
| Monday, December 3, 12:00 – 2:00 pm CT |
| A Specific Serotonin Receptor is Critical in the Ability of Fenfluramine to Prevent Seizure-Induced Respiratory Arrest (S-IRA) in the DBA/1 Mouse Model of SUDEP |
| Presented by: Srinivasan Tupal, Ph.D., Southern Illinois University School of Medicine, Springfield, IL |
| Poster Session #: 2.230 |
| Sunday, December 2, 12:00 – 2:00 pm CT |
| Assessing Quality of Life in Siblings of Children With Severe Epileptic Encephalopathies: Comparative Analysis of Sibling Self-reports and Parental Perception of Sibling Responses | |||||
| Presented by: Laurie Bailey, Zogenix, Inc., Emeryville, CA | |||||
| Poster Session #: 2.243 Sunday, December 2, 12:00 – 2:00 pm CT | |||||
| Brief Scales for Caregivers of Children With Epilepsy | |||||
| Presented by: Mark Jensen, Ph.D., University of Washington Medicine, Seattle, WA | |||||
| Poster Session #: 2.406 Sunday, December 2, 12:00 – 2:00 pm CT | |||||
| Psychosocial Concerns of Siblings Growing Up With a Brother or Sister With a Severe Epileptic Encephalopathy | |||||
| Presented by: Laurie Bailey, Zogenix, Inc., Emeryville, CA | |||||
| Poster Session #: 2.424 Sunday, December 2, 12:00 – 2:00 pm CT | |||||
| Improved Everyday Executive Function With Fenfluramine HCl Oral Solution (Fintepla®): Results From a Phase 3 Study in Children and Young Adults With Dravet Syndrome | |||||
| Presented by: Kim I. Bishop, Ph.D., Global Pharma Consultancy, LLC, Basel, Switzerland | |||||
| Poster Session #: 2.454 Sunday, December 2, 12:00 – 2:00 pm CT | |||||
About Zogenix
Zogenix is committed to developing and commercializing transformative therapies to improve the lives of patients and their families living with rare diseases. For more information, visit www.zogenix.com.
Forward Looking Statements
Zogenix cautions you that statements included in this press release or in the poster presentations 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 include Zogenix’s plans to present data and other posters at AES and the potential efficacy of FINTEPLA (ZX008). These statements are based on Zogenix’s current beliefs and expectations. 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 or in any poster presentation 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 FINTEPLA; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA that could limit approval and/or commercialization, or that could result in recalls or product liability claims; 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
Media: Rachel Lipsitz
Public Relations, Syneos Health
858-449-9575 | rachel.lipsitz@syneoshealth.com