Sunday, February 09, 2020 9:41:41 PM
Zogenix down 33% after hours on disappointing Fintepla data
Feb. 6, 2020 4:41 PMZogenix, Inc. (ZGNX)GWPHBy: Douglas W. House, SA News Editor
Zogenix (NASDAQ:ZGNX) slumps 33% after hours in reaction to its announcement of results from a Phase 3 clinical trial evaluating two doses of Fintepla (fenfluramine oral solution) (ZX008) in patients with a severe form of childhood-onset epilepsy called Lennox-Gastaut syndrome.
The company says the higher dose met the primary endpoint of the change from baseline in seizure frequency compared to placebo. Specifically, patients receiving 0.7 mg/kg/day experienced a median reduction of 26.5% in monthly drop seizure frequency versus 7.8% for control (p=0.0012). The proportion of patients with at least a 50% reduction in monthly drop seizures, a secondary endpoint, was 25.3% compared to 10.3% for placebo (p=0.0165).
The results for the lower dose (0.2 mg/kg/day) were not statistically significant.
Phase 2 data published in September 2018 showed a 53% median reduction in seizure frequency with 62% of treated patients experiencing at least a 50% drop (median dose of 0.4 mg/kg/day).
By comparison, 20 mg/kg/day of GW Pharmaceuticals' (GWPH +7.1%) Epidiolex (cannabidiol) resulted in a 44% median reduction drop seizure frequency (vs. 22% for placebo) (package insert data).
GW Pharmaceuticals (NASDAQ:GWPH), whose Epidiolex (cannabidiol) was approved for Lennox-Gastaut in June 2018, is up 9% after hours.
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