Zogenix Phase 2 Study Results Published in Epilepsia Show ZX008 Provides Durable Reduction in Seizure Frequency in Patients With Lennox-Gastaut Syndrome
67% of Patients Achieved At Least a 50% Reduction in Convulsive Seizures
Global Phase 3 Randomized, Controlled Study in LGS Currently Enrolling Patients
“This study was designed to confirm the potential effectiveness of ZX008 for patients with LGS,” said
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.
Patients enrolled in the study (n=13) had refractory LGS and a baseline median seizure frequency of 61 per month (range: 21-1360) with multiple seizure types (defined as tonic, generalized tonic-clonic, myoclonic, absence, and atonic seizures/drop attacks). Patients failed a median of five anti-epileptic treatments, including vagus nerve stimulation and ketogenic diet (range: 3-7). Patients achieved a 53% median reduction in convulsive seizure frequency during the 20-week treatment period of the core study. A reduction in convulsive seizure frequency of at least 50% was seen in 62% of patients, with a reduction of at least 75% being reported in 23% of patients. The median dose of ZX008 was 0.4 mg/kg/day.
After 15 months in the long-term extension study (n=9), patients achieved a 58% median reduction in convulsive seizure frequency over the entire treatment period compared to baseline. Of these patients, 67% achieved at least a 50% reduction, and 33% achieved at least a 75% reduction in convulsive seizure frequency. At 15 months, the median dose of ZX008 was 0.4 mg/kg/day.
“The compelling results of this study supported commencing a global Phase 3 pivotal trial to evaluate the efficacy and safety of ZX008 for the treatment of seizures associated with LGS,” said
ZX008 was generally well-tolerated in this study and demonstrated a safety profile consistent with the findings of completed Phase 3 studies of ZX008 in patients with Dravet syndrome. No patient exhibited cardiac valvulopathy or pulmonary hypertension at any time in the study. The most common adverse events were decreased appetite (n=4; 31%) and decreased alertness (n=2; 15%).
LGS is a rare, severe form of epilepsy, marked by frequent and prolonged seizures, with peak onset between ages 3 and 5.1 LGS impacts approximately 30,000 – 50,000 people in the U.S. and
ZX008 for the treatment of LGS has previously been designated as an orphan drug by both the
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- Ferlazzo, E. et al. Lennox-Gastaut syndrome with late-onset and prominent reflex seizures in trisomy 21 patients. Epilepsia. 2009 Jan;50(6):1587-1595.
- Crumrine PK. Management of Seizures in Lennox-Gastaut Syndrome. Pediatric Drugs. 2011:13 (2): 107-118.
Source: Zogenix, Inc.