- Zogenix (NASDAQ:ZGNX) is set for a big move today after announcing positive results from a Phase 3 clinical trial assessing lead candidate ZX008 (low-dose fenfluramine hydrochloride) in patients with a rare and severe form of epilepsy called Dravet syndrome, a Fast Track-designated indication.
- The 119-subject study met its primary endpoint of demonstrating superiority to placebo as measured by the change in the frequency of convulsive seizures from baseline (p<0.001). All key secondary endpoints were also met.
- ZX008 was generally well-tolerated with the occurrence of adverse events consistent with the known safety profile of fenfluramine. The incidence of treatment-emergent adverse events in the ZX008 cohort was 95.0% in the high dose (0.8 mg/kg/day) group and 94.9% in the low (0.2 mg/kg/day) dose group compared to 65.0% for placebo. The rates of serious adverse events in the three groups were 12.5%, 10.3% and 10.0%, respectively. Five participants discontinued treatment.
- A second Phase 3, Study 1504, is underway.
- Management will host a conference call this morning at 8:30 am ET to discuss the results.
- Update: Shares are up 212% premarket on robust volume.
- Now read: Zogenix: The Proof Is In The Publications
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