Updated Results of Phase 2 Study of ZX008 in Lennox Gastaut Syndrome to be Presented
Data Demonstrating Disease Burden and Negative Impact on Quality of Life of Patients and Families Will Also be Presented
EMERYVILLE, Calif., Nov. 21, 2017 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a pharmaceutical company developing therapies for the treatment of rare central nervous system (CNS) disorders, today announced the presentation of nine scientific posters adding to the growing body of evidence to support the continued investigation of ZX008 (low-dose fenfluramine) in rare, intractable forms of childhood onset epilepsy and two posters underscoring the significant burden Dravet syndrome and other forms of epileptic encephalopathies have on caregivers and family members. These posters will be presented at the 71st American Epilepsy Society (AES) Annual Meeting, which will take place at the Washington Convention Center in Washington, D.C., from December 1-5, 2017, and will also be presented in a Zogenix-hosted Scientific Exhibit Room on Sunday, December 3.
The data that will be presented during the poster sessions include additional efficacy and safety results from the first pivotal Phase 3 trial (Study 1) of ZX008 in patients with Dravet syndrome. Positive top-line results from this study were announced in September 2017 and demonstrated that as adjunctive therapy, ZX008 achieved statistically significant (p<0.001) convulsive seizure reduction compared to placebo. In addition to the Study 1 results, two other clinical study posters will provide updated results from the ongoing investigator-initiated, open label studies in Dravet syndrome and Lennox-Gastaut Syndrome. There will also be several scientific posters focused on the pharmacokinetics of ZX008, including an evaluation of interactions between Zogenix’s product candidate and other antiepileptic drugs, as well as information about ZX008’s potential mechanism of action. Additionally, two posters will focus on disease impact on caregivers in pediatric epilepsies, such as Dravet syndrome.
Finally, on Sunday, December 3, from 8:00 AM to 5:00 PM, Zogenix will host a Scientific Exhibit Room entitled, “Low-Dose Fenfluramine: An Update on Mechanisms, Efficacy, and Safety in the Treatment of Epileptic Encephalopathies.” In this Scientific Exhibit Room, Zogenix will feature the complete suite of preclinical, clinical and pharmacokinetics research on ZX008 and the impact of Dravet syndrome that will be presented at the AES Annual Meeting. Poster authors will be available to answer questions on their data at specified times.
Zogenix at the 71st AES Annual Meeting
| Saturday, December 2 – Poster Session 1 | ||
| Title: | Prophylaxis of Seizure-Induced Respiratory Arrest (S-IRA) with Fenfluramine in a Mouse Model of SUDEP | |
| Presenter: | Srinivasan Tupal, Southern Illinois University School of Medicine | |
| Poster Session #: | 1.268 | |
| Title: | Fenfluramine in the Treatment of Drug-Resistant Seizures: Back-Translation using Zebrafish and Mice | |
| Presenter: | Jo Sourbron, Laboratory for Molecular Biodiscovery, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium | |
| Poster Session #: | 1.275 | |
| Sunday, December 3 – Poster Session 2 | ||
| Title: | Fenfluramine Has In Vivo Activity as a Positive Allosteric Modulator of Sigma-1 Receptors | |
| Presenter: | Parthena Martin, Director, Non-Clinical Development, Zogenix, Inc. | |
| Poster Session #: | 2.032 | |
| Title: | ZX008 (Fenfluramine) in Dravet Syndrome: Results of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial | |
| Presenter: | Lieven Lagae, Professor Division of Paediatric Neurology, University Hospital Leuven | |
| Poster Session #: | 2.434 | |
| Title: | A Pilot, Open-Label, Dose-Finding Study of the Effectiveness and Tolerability of Low-Dose Fenfluramine (ZX008) in Lennox-Gastaut Syndrome | |
| Presenter: | Lieven Lagae, Professor Division of Paediatric Neurology, University Hospital Leuven | |
| Poster Session #: | 2.284 | |
| Title: | A Randomized, Open-Label, Single-Dose, 3-Way Crossover Study to Evaluate the Drug-Drug Interaction Between ZX008 (Fenfluramine Oral Solution) and Stiripentol/ Clobazam/ Valproate in Healthy Volunteers | |
| Presenter: | Brooks Boyd, Vice President, Development, Zogenix, Inc. | |
| Poster Session #: | 2.282 | |
| Title: | The Lack of Effect of Food on the Pharmacokinetics of ZX008 (Fenfluramine Oral Solution): Results of a Single-Dose, Two-Period Crossover Study | |
| Presenter: | Arnold Gammaitoni, VP of Global Medical and Scientific Affairs, Zogenix, Inc. | |
| Poster Session #: | 2.285 | |
| Title: | ZX008 (Fenfluramine Oral Solution) as Adjunctive Therapy for Dravet Syndrome Seizures: A Pharmacometric Approach to Quantify Potential Drug-Drug Interactions to Support Phase 3 Dose Selection | |
| Presenter: | Christopher Rubino, Institute for Clinical Pharmacodynamics | |
| Poster Session #: | 2.283 | |
| Title: | Development of the Caregiver Stress Scale for Caregivers of Children with Epilepsy | |
| Presenter: | Dagmar Amtmann, Department of Rehabilitation Medicine, University of Washington, Seattle, WA | |
| Poster Session #: | 2.407 | |
| Title: | Assessing the Impact of Caring for a Child with Dravet Syndrome: Results of a Caregiver Survey | |
| Presenter: | Jonathan Campbell, Clinical Pharmacy, University of Colorado Anschutz Medical Campus | |
| Poster Session #: | 2.408 | |
| Sunday, December 3 – Scientific Exhibit Room | ||
| Low-Dose Fenfluramine: An Update on Mechanisms, Efficacy, and Safety in the Treatment of Epileptic Encephalopathies | ||
| Date: | Sunday, December 3, 2017 | |
| Time: | 8:00 AM to 5:00 PM | |
| Location: | Scientific Exhibit Room 102 B, Street Level of the Walter E. Washington Convention Center | |
| Monday, December 4 – Poster Session 3 | ||
| Title: | Low-Dose Fenfluramine Provides Significant and Long-Term Seizure Reduction in Dravet Syndrome: Update and Follow-up of the Prospective Study | |
| Presenter: | An-Sofie Schoonjans, Department of Neurology-Pediatric Neurology, Antwerp University Hospital, University of Antwerp, Belgium | |
| Poster Session #: | 3.264 | |
About Zogenix
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 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 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 ZX008; 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; 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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Public Relations, INC Research/inVentivHealth
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