Zogenix, Inc. (NASDAQ: ZGNX) is having yet another relatively strong day in the market today, and for good reason. Recently, the company released positive Phase 3 clinical data surrounding a treatment they have been working on for Dravet syndrome; a rare, yet severe form of epilepsy. While the data was first released last week, messages on message boards around the web show that the excitement has yet to die down. Of course, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:42), ZGNX is trading at $36.90 per share after a gain of $1.85 per share or 5.28% thus far today.
ZGNX Continues Skyward On Phase 3 Data
As mentioned above, Zogenix is having yet another incredible day in the market today following last week’s announcement of positive Phase 3 clinical data. The trial, assessing the clinical benefit of ZX008, a treatment for Dravet syndrome, proved to generate overwhelmingly positive results.
The Phase 3 trial was a randomized, double-blind, placebo-controlled study. 119 patients in the United States, Canada, Europe, and Australia with a median age of 8 years were enrolled into the study. The ZGNX study included a 6-week baseline observation period and patients were randomized into one of 3 groups. Patients were titrated to their target dose for more than 2 weeks and then remained at a fixed dose for 12 weeks. ZGNX informed investors that the mean baseline convulsive seizure frequency across the study groups was around 40 seizures per month. Here are the results that have investors clamoring to get their hands on Zogenix stock:
- Primary Endpoint – The primary endpoint of the study was an assessment of the change in the mean monthly convulsive seizure frequency between ZX008 0.8 mg/kg/day and placebo during the 14-week treatment period when compared to the 6-week baseline observation period.
- Primary Result – ZGNX said that patients who were taking ZX008 0.8 mg/kg/day attained a 63.9% reduction in mean monthly convulsive seizures compared to placebo. Also, the median percent reduction in monthly convulsive seizure frequency was 72.4% among ZX008 0.8 mg/kg/day patients compared to 17.4% in placebo patients.
- Smaller Dose – ZGNX also said that patients taking a smaller dose of ZX008 at only 0.2 mg/kg/day completed a reduction in the mean monthly convulsive seizures of 33.7% compared to placebo.
- Seizure Free Interval – Finally, the company said that the longest seizure-free interval for ZX008 0.8 mg/kg/day was found to be 20.5 days. For the smaller dose of 0.2 mg/kg/day, the longest seizure free interval was 14 days. Both of these proved to be compelling as 9 days was the longest seizure free interval in patients taking the placebo.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will be keeping a close eye on ZGNX. In particular, we’re interested in following the ongoing work surrounding ZX008 and considering the strong Phase 3 clinical results, we’ll be looking for an NDA relatively soon. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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