Zogenix Announces Positive Top-line Results from Global Pivotal Phase 3 Trial of FINTEPLA® for the Treatment of Lennox-Gastaut Syndrome
- Primary Endpoint Achieved – Statistically Significant Reduction in Drop Seizures for FINTEPLA 0.7 mg/kg/day versus Placebo
- FINTEPLA Also Demonstrated Statistically Significant Improvement on Multiple Secondary Endpoints
- Zogenix to Host Conference Call and Live Webcast Today at 4:30 PM Eastern Time/1:30 PM Pacific Time
EMERYVILLE, California, February 6, 2020 – Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today reported positive top-line results from its global Phase 3 clinical trial (Study 1601) of its lead investigational therapy, FINTEPLA® (ZX008, fenfluramine oral solution) in Lennox- Gastaut Syndrome (LGS), a severe and treatment-resistant childhood-onset epilepsy. The trial met its primary objective of demonstrating that FINTEPLA at a dose of 0.7 mg/kg/day was superior to placebo in reducing the frequency of drop seizures, based on the change between baseline and the titration and maintenance treatment period (p=0.0012). The same dose of FINTEPLA (0.7 mg/kg/day) also demonstrated statistically significant improvements versus placebo in key secondary efficacy measures, including the proportion of patients with a clinically meaningful reduction (≥50%) in drop seizure frequency. A decrease in the frequency of drop seizures between baseline and the treatment period was observed for a lower dose of FINTEPLA (0.2 mg/kg/day) compared to placebo, but this change did not reach statistical significance (p=0.0915). FINTEPLA was generally well- tolerated, with the adverse events consistent with those observed in the Company’s two prior Phase 3 studies in Dravet syndrome.
“LGS is a rare and severe form of epilepsy where nearly all patients have highly treatment resistant and lifelong seizures. As a result, the frequent falls and injuries, and also the cognitive impairment, limit the quality of life for patients and caregivers, even with current treatment options,” said Associate Professor Kelly Knupp, M.D., MSCS, FAES of Children’s Hospital Colorado, Principal Investigator for Study 1601. “The results observed in this placebo- controlled study are indicative of the potential of fenfluramine to treat patients with refractory LGS. If approved, FINTEPLA could represent an important new treatment option for these patients and their families in need.”Read More