Zogenix Announces Positive Phase 3 Trial Results on the Efficacy and Safety of FINTEPLA (ZX008) in Dravet Syndrome

Zogenix (NASDAQ:ZGNX) a pharmaceutical company developing therapies for the treatment of rare diseases, announced today that late-breaking data will be presented on the use of its investigational drug, FINTEPLA^® (ZX008; low-dose fenfluramine), in children and young adults with Dravet syndrome.

As quoted in the press release:

These three presentations will include data from the second pivotal Phase 3 trial (Study 1504), and long-term efficacy and safety data from a formal interim analysis of the ongoing open-label extension (OLE) trial (Study 1503). A post-hoc exploration of the clinical meaningfulness of seizure control from the first pivotal Phase 3 trial (Study 1) will also be presented. The data will be presented at the 72^ndAmerican Epilepsy Society (AES) Annual Meeting in New Orleans. Full posters can be found on www.zogenix.com here.

Results from Study 1504 (poster 3.461) will be presented as a follow-up to top-line results that were released in July 2018. Patients (n=87) in Study 1504 were taking a background anti-epileptic drug (AED) medication regimen that included stiripentol and were randomized to placebo (n=44) or FINTEPLA 0.5 mg/kg/day (n=43).  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.

Click here to read the full press release.