1:34 PM
Jul 12, 2018
 |  BC Extra  |  Clinical News

Zogenix market cap grows with second Phase III win

Zogenix Inc. (NASDAQ:ZGNX) gained $9.60 (21%) to $55.90 on Thursday, adding about $338 million in market cap, after it reported top-line data showing ZX008 as an adjunctive therapy to stiripentol regimen met the primary endpoint in its second Phase III trial, Study 1504, to treat Dravet syndrome.

Daily 0.5 mg/kg oral ZX008 led to a 54.7% greater reduction in mean monthly convulsive seizures from baseline to week 15 compared with placebo (p<0.001).

ZX008 was also superior to placebo on all key secondary endpoints, including a percentage of patients achieving ≥50% (53.5% vs. 6.8%, p<0.001) and ≥75% reduction in monthly convulsive seizures (32.6% vs. 2.3%, p=0.004), and median longest seizure-free interval (22 vs. 13 days, p<0.005).

The double-blind, international trial enrolled 87 patients ages 2-19 on stable background therapy of stiripentol plus other antiepileptic drugs.

Zogenix reiterated plans to submit U.S. and EU regulatory applications in 4Q18. The company said FDA affirmed earlier this year that the Phase III Study 1 and Study 1504 trials were a suitable basis for an NDA submission.

Last year, ZX008 met the primary endpoint in Study I as an adjunctive therapy for Dravet syndrome. Study 1 did not permit use of stiripentol (see "Zogenix Soars on Phase III Data for Dravet Syndrome Candidate").

ZX008 is an oral solution of low-dose fenfluramine, a derivative of amphetamine that promotes the release of serotonin (5-HT) from neuronal storage vesicles and inhibits its reuptake.

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