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Zogenix Announces Presentation of New Data for FINTEPLA® for the Treatment of Dravet Syndrome at the Child Neurology Society Annual Meeting

EMERYVILLE, Calif., Oct. 21, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (ZGNX), a global pharmaceutical company developing rare disease therapies, announced that five posters related to its investigational therapy, FINTEPLA® (ZX008, fenfluramine oral solution), will be presented at the 48th Annual Meeting of the Child Neurology Society (CNS) being held in Charlotte, North Carolina, from October 23-26, 2019. The data will include pooled analyses of two pivotal Phase 3 studies, long-term safety and efficacy from the open-label extension trial of FINTEPLA for the treatment of seizures associated with Dravet syndrome, and new data on the impact of the relationships between caregiver-reported self-regulation and quality-of-life ratings in children and young adults with Dravet syndrome.

Below are the titles of the five posters that will be presented at the 2019 CNS Annual Meeting.  Authors will be available to answer questions on their posters at the times specified below.

  1. ZX008 (Fenfluramine HCl Oral Solution) Provides Long-Term, Clinically Meaningful Reduction of Convulsive Seizure Frequency in Young (<6 years old) Dravet Syndrome Subjects: Analysis from Long-Term Open-Label Study (J. Sullivan, R. Nabbout, K. Knupp et al)
    • Poster #62
    • Thursday, October 24, 4:00 – 5:30 pm
      & Friday, October 25, 7:00 – 8:15 am Eastern Time (ET)

       
  2. Defining a Minimal Clinically Important Difference in Seizure Frequency Using Data from a Phase 3 Clinical Study of Add-On, Low-Dose ZX008 (Fenfluramine HCl Oral Solution) in Dravet Syndrome Patients Receiving an Antiepileptic Drug Regimen Containing Stiripentol (A. Gammaitoni, J. Sullivan, D. Dlugos et al)
    • Poster #44
    • Thursday, October 24, 4:00 – 5:30 pm
      & Friday, October 25, 7:00 – 8:15 am ET

       
  3. ZX008 Fenfluramine HCl Significantly Reduces Frequency of Generalized Tonic-Clonic Seizures
    in Dravet Syndrome: Pooled Analysis from Two Phase 3 Clinical Trials (
    O. Devinsky, J. H. Cross,
    A. Gil-Nagel et al.)
    • Poster #41
    • Thursday, October 24, 12:45 – 2:00 pm
      & Thursday, October 24, 4:00 – 5:30 pm ET

       
  4. A Phase 1, Single-Dose, Open-Label Pharmacokinetic Study to Investigate the Drug-Drug Interaction Potential of ZX008 (Fenfluramine HCl Oral Solution) and Cannabidiol (B. Boyd, S. Smith, G. Farfel et al)
    • Poster #: 38
    • Thursday, October 24, 4:00 – 5:30 pm
      & Friday, October 25, 7:00 – 8:15 am ET

       
  5. Relationships Between Self-Regulation and Quality of Life: Results from a Phase 3 Study of ZX008 (Fenfluramine HCl Oral Solution) in Children and Young Adults with Dravet Syndrome (K. Bishop,
    G. Gioia, P. Isquith, G. Morrison)
    • Poster #36
    • Thursday, October 24, 4:00 – 5:30 pm
      & Friday, October 25, 7:00 – 8:15 am ET

About Zogenix

Zogenix is a global pharmaceutical company whose mission is to develop and commercialize therapies that transform the lives of patients and their families living with rare diseases. The company has two late-stage development programs underway: FINTEPLA® (ZX008, fenfluramine) for the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes, two rare and often-catastrophic childhood-onset epilepsies, and MT1621, a combination deoxynucleoside substrate enhancement therapy for the treatment of TK2 deficiency, a rare, debilitating, and often fatal genetic disorder that primarily affects infants and children and for which there are currently no approved therapies.

Zogenix recently resubmitted its New Drug Application for FINTEPLA for Dravet syndrome to the U.S. Food & Drug Administration; its application for FINTEPLA for Dravet syndrome is under review by the European Medicines Agency. Zogenix expects top-line data from its Phase 3 study of FINTEPLA in Lennox-Gastaut syndrome in the first quarter of 2020. FINTEPLA is also in development in Japan. Zogenix acquired Modis Therapeutics and the MT1621 program in September 2019.

Forward-Looking Statement
Zogenix cautions you that statements included in this press release or 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: the safety and efficacy profile of, and the potential for, FINTEPLA, if approved, to provide an important new treatment option for patients and families living with Dravet syndrome; and the potential timing of top-line data the on-going Phase 3 trial of FINTEPLA in patients with Lennox-Gastaut syndrome (LGS). 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 the poster presentations due to the risks and uncertainties inherent in Zogenix’s business, including, without limitation: the FDA may not accept or approve the resubmitted NDA for FINTEPLA; the timing of the data from Study 1601 of FINTEPLA in patients suffering from LGS could be delayed; the FDA may not agree with Zogenix’s interpretation of the results of the clinical trials of FINTEPLA, including any data presented in the poster presentations; the uncertainties associated with the clinical development and regulatory approval of product candidates such as FINTEPLA; and other risks described in Zogenix’s prior press releases as well as in public periodic filings with the U.S. Securities & 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.

CONTACTS:

Zogenix
Melinda Baker
Senior Director, Corporate Communications
+1 (510) 788-8732 | corpcomms@zogenix.com 

Investors
Andrew McDonald
Founding Partner, LifeSci Advisors LLC
+1 (646) 597-6987 | Andrew@lifesciadvisors.com