Zogenix offered investors exactly the kind of gourmet data they were looking for this morning with a clean sweep of promising data for its late-stage drug ZX008, designed to tackle a severe form of childhood epilepsy. And the news powered a big spike in its share price $ZGNX as Wall Street continues to shower rewards on clear successes.
The first of two Phase III studies for this drug, researchers say they tracked a clear dose-dependent response for this treatment, with a dramatic drop in the rate of seizures experienced by patients with Dravet syndrome.
The key score: At the high end, the dose cut the monthly convulsive seizure frequency by 72.4% in the 0.8 mg/kg/day patients drug arm compared to a 17.4% drop in placebo patients.
The drug also scored a clean sweep on the secondary endpoints.
Zogenix’s stock price initially soared more than 200% on the news, a sign of the euphoria that now greats a big win in biotech. But the zeal cooled a little and by mid-morning the biotech had to settle for a 123% jump in share price.
Leerink’s Paul Matteis was among the first analysts to offer a congratulatory note this morning:
Not only did the clinical trial meet its primary endpoint with a high degree of statistical significance – the magnitude of clinical benefit was better than we expected, and in the ballpark of prior compassionate use studies that conveyed an unprecedented level of benefit.
The biotech is well on its way to completing enrollment for Study 2, which is expected to read out in H1 2018, with a new drug application to follow in the second half — provided all goes according to plan.
Zogenix’s success came at the expense of GW Pharmaceuticals $GWPH, which had less impressive – though positive — late stage data of its own last year. GW said that Epidiolex — a liquid therapy using purified cannabadiol — triggered a mean reduction in convulsive seizures of 39% among treatment-resistant patients with Dravet syndrome, compared to only 13% among the placebo group.
GW’s stock plunged 15% this morning.
This is the last big stock catalyst expected in Q3, which has seen a series of dramatic ups and downs in the biotech arena.
“We are extremely pleased with the top-line efficacy and safety results from Study 1 which reinforce the potential of ZX008 to be an important new treatment for seizure control in children with Dravet syndrome. We look forward to presenting further data in future publications and at medical conferences,” said CEO Stephen Farr in a statement.
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