Zogenix presents data on Fintepla at Epilepsy Society

 Zogenix announced that late-breaking data will be presented on the use of its investigational drug, Fintepla, in children and young adults with Dravet syndrome. These three presentations will include data from the second pivotal Phase 3 trial and long-term efficacy and safety data from a formal interim analysis of the ongoing open-label extension, or OLE, trial. A post-hoc exploration of the clinical meaningfulness of seizure control from the first pivotal Phase 3 trial will also be presented. The data will be presented at the American Epilepsy Society, or AES. Results from Study 1504 will be presented as a follow-up to top-line results that were released in July. Patients in Study 1504 were taking a background anti-epileptic drug medication regimen that included stiripentol and were randomized to placebo or Fintepla 0.5 mg/kg/day. Following a six-week baseline observation period, patients were titrated to their target dose over three weeks and then remained at that fixed dose for 12 weeks. Consistent with Study 1, Study 1504 met the primary endpoint and all key secondary endpoints. Results demonstrated the statistically significant efficacy of Fintepla when added to a stiripentol regimen in children and young adults with Dravet syndrome. Data from Study 1503 will be presented in two posters, one that focuses on effectiveness and overall tolerability of Fintepla and a second on the long-term cardiovascular assessments and observations. A total of 232 patients in Study 1503 were included in the interim analysis of the ongoing OLE trial. The median duration of treatment with Fintepla was 256 days and the range was 58-634 days. A total of 22 patients discontinued treatment. More than 90% of patients remained in the study.
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