Zogenix's ZX008 meets in Phase III for Dravet syndrome

Zogenix Inc. (NASDAQ:ZGNX) reported top-line data showing that ZX008 as adjunctive therapy met the primary endpoint of reducing mean monthly convulsive seizure frequency in the Phase III Study 1 to treat Dravet syndrome. Top-line data from the second Phase III trial -- Study 1504 -- of ZX008 to treat Dravet syndrome are expected next half, with regulatory submissions in the U.S. and EU to follow in 2H18.

On the primary endpoint, once-daily 0.8 mg/kg ZX008 reduced mean monthly convulsive seizure frequency from baseline to week 14 by 63.9% vs. placebo (p<0.001). ZX008 led to a median reduction in monthly convulsive seizure frequency of 72.4% vs. 17.4% for placebo. ZX008 also met all secondary endpoints, including a greater proportion of patients who achieved a ≥50% (70% vs. 7.5%, p<0.001) and ≥75% (45% vs. 2.5%, p=0.001) reduction in monthly convulsive seizures and of improving longest seizure-free interval (20.5 vs. 9 days, p<0.001), vs. placebo...