Zogenix Phase 2 Study Show Durable Reduction in Seizure Frequency

67% of Patients Achieved At Least a 50% Reduction in Convulsive Seizures

Global Phase 3 Randomized, Controlled Study in LGS Currently Enrolling Patients

Zogenix, Inc. (NASDAQ:ZGNX), a pharmaceutical company developing therapies for the treatment of rare central nervous system (CNS) disorders, today announced that detailed results of the Phase 2, open-label study evaluating its investigational drug, ZX008 (low-dose fenfluramine hydrochloride), for the treatment of refractory patients with Lennox-Gastaut Syndrome (LGS), were published in the September 2018 issue of Epilepsia. Consistent with the previously-reported data from this study, the results demonstrated that ZX008 provided sustained, clinically meaningful seizure reduction in the majority of patients and was generally well-tolerated.

“This study was designed to confirm the potential effectiveness of ZX008 for patients with LGS,” said Lieven Lagae, M.D., Ph.D., lead study author and professor at the University of Leuven, Belgium, head of the Pediatric Neurology Department and director of the Childhood Epilepsy Program at the University of Leuven Hospitals. “The clinically meaningful reduction in convulsive seizures in this highly refractory patient cohort emphasizes the importance of the ongoing Phase 3 study of ZX008 as a treatment for LGS patients, who continue to struggle with seizure control despite current therapies.”

The single-center, Phase 2, open-label dose-finding trial was a 20-week core study and a long-term extension option for those patients who were responders in the core study. Results presented in the paper included up to 15 months of treatment for patients in the long-term extension. Patients initiated treatment of 0.2 mg/kg/day ZX008 twice-daily. Patients who were responders (i.e., achieved > 50% reduction in convulsive seizure frequency after 4 weeks) remained at their effective dose, while non-responders were considered for a dose increase up to 0.8 mg/kg/day at 0.2 mg/kg increments per 4 weeks.

https://www.biospace.com/article/zogenix-phase-2-study-results-published-in-epilepsia-show-zx008-provides-durable-reduction-in-seizure-frequency-in-patients-with-lennox-gastaut-syndrome/