Featured Company News – Zogenix Shares Positive Results from Phase-3 Clinical Trial of ZX008 for Treating Dravet Syndrome

LONDON, UK / ACCESSWIRE / October 2, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Zogenix, Inc. (NASDAQ: ZGNX), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=ZGNX. The Company announced on September 29, 2017, positive top-line results from its first Phase-3 trial (“Study 1”) for its investigational drug, ZX008 (low-dose fenfluramine hydrochloride) used for the treatment of the Dravet syndrome. For immediate access to our complimentary reports, including today’s coverage, register for free now at:

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The Dravet syndrome is a genetic dysfunction in the brain, which leads to potentially fatal, long-lasting, fever-related seizures that do not respond to standard treatment. The trial achieved its primary endpoint, which showed that ZX008, at a dose of 0.8 mg/kg/day, showed better results than placebo as an adjunctive therapy in the treatment of the Dravet syndrome in children and young adults based on change in the frequency of convulsive seizures between the 6-week baseline observation period and the 14-week treatment period. ZX008 0.8 mg/kg/day also exhibited statistically significant improvements versus placebo in all key secondary measures. Likewise, ZX008 0.2 mg/kg/day dose also demonstrated statistically significant improvement compared to placebo.

ZX008 Could be a Savior for Patients With Dravet Syndrome

Joseph Sullivan M.D., Director of the Pediatric Epilepsy Center in UCSF Benioff Children’s Hospital San Francisco, and Principal Investigator of Study 1 in the US, expressed his views on the trial results. He highlighted that the Dravet syndrome is a rare and catastrophic form of epilepsy, which can be devastating for patients as well as their families. He is particularly thrilled with the results for the Phase-3 clinical trial of ZX008. He believes the results validate the remarkable effectiveness of low-dose fenfluramine for patients with the Dravet syndrome, and if the drug gets approved, it would play a critical role in treating this challenging disease.

Study Design

The Phase-3 clinical trial is a randomized, double-blind, placebo-controlled study. Around 119 patients across sites in the United States, Canada, Europe, and Australia with a median age of 8 years (and range of 2 – 18 years) were enrolled for this study. It comprised a 6-week baseline observation period, post which patients were randomized to one of three treatment groups: (i) ZX008 0.8 mg/kg/day (30 mg maximum daily dose; n=40); (ii) ZX008 0.2 mg/kg/day (n=39); and (iii) placebo (n=40) in which ZX008 or placebo was added to current regimens of antiepileptic drugs. Patients were titrated to their target dose for more than two weeks and then remained at that fixed dose for 12 weeks. The mean baseline convulsive seizure frequency across the study groups was nearly 40 seizures per month.

Study Endpoints and Results

The primary endpoint measure was an assessment of the change in mean monthly convulsive seizure frequency between ZX008 0.8 mg/kg/day and placebo during the 14-week treatment period versus the 6-week baseline observation period.
The patients who were taking ZX008 0.8 mg/kg/day attained a 63.9% reduction in mean monthly convulsive seizures compared to placebo (p<0.001). Whereas, 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.
A key secondary endpoint was a similar analysis for a comparison of ZX008 0.2 mg/kg/day and placebo.
Patients taking ZX008 0.2 mg/kg/day completed a reduction in mean monthly convulsive seizures of 33.7% compared to placebo (p=0.019).
As a whole, these top-line results demonstrate a dose-response relationship for ZX008 in the adjunctive treatment of convulsive seizures in the Dravet syndrome.
Other key secondary objective of the study was to compare 0.8 mg/kg/day and 0.2 mg/kg/day ZX008 (independently) with placebo in terms of
the proportion of patients who achieved ≥50% reductions in monthly convulsive seizures;
the median of the longest convulsive seizure-free interval; and
the proportion of patients who achieved ≥75% seizure reductions.
The proportion of patients with ≥50% reduction in monthly convulsive seizures was 70% for ZX008 0.8 mg/kg/day (p<0.001) compared to 41% for ZX008 0.2 mg/kg/day (p=0.001), and 7.5% for placebo. Similarly, the proportion of patients with ≥75% reduction in monthly convulsive seizures was 45% for ZX008 0.8 mg/kg/day (p=0.001) compared to 20.5% for ZX008 0.2 mg/kg/day (p=0.033), and 2.5% for placebo.
The longest seizure-free interval (median) for ZX008 0.8 mg/kg/day was found to be 20.5 days (p<0.001) compared to 14 days for ZX008 0.2 mg/kg/day (p=0.011), and 9 days for placebo.

Adverse Effects Found to be Within Safety Profile

ZX008 was mostly well tolerated in this study as the adverse events were in-line with the known safety profile of fenfluramine. The incidence of treatment-emergent adverse events was greater in the treatment groups versus the placebo group, with 95% (n=38) of patients in the 0.8mg/kg/day group, and 94.9% (n=37) of patients in the 0.2 mg/kg/day group suffering at least one treatment-emergent adverse event compared to 65.0% (n=26) of patients in the placebo group.
On the other hand, the incidence of serious adverse events was similar in all the three groups with 12.5% (n=5) of patients in the 0.8 mg/kg/day group and 10.3% (n=4) of patients in the 0.2 mg/kg/day group suffering at least one treatment-emergent serious adverse event compared to 10.0% (n=4) of patients in the placebo group.
In fact, five patients in the 0.8 mg/kg/day segments had an adverse event, which led to study discontinuation compared to none in the other treatment groups.
Moreover, prospective cardiac safety monitoring throughout the study showed no clinical or echocardiographic proof of cardiac valvulopathy or pulmonary hypertension.

Zogenix on Track for Filing Regulatory Applications in the US

After getting positive results for ZX008 Phase-3 clinical trial, Stephen J. Farr, Ph.D., President and CEO of Zogenix extended sincere appreciation for the patients, families, and investigators involved in the study. He mentioned that his team is delighted with the top-line efficacy and safety results from Study 1, which reaffirms the potential of ZX008 in being a vital treatment for seizure control in children with the Dravet syndrome.

Besides, Farr also looks forward to presenting further data in future publications and at medical conferences. He anticipates to receive the top-line results from the second pivotal Phase-3 trial, Study 1504 (which is nearing full enrollment) in the first half of 2018. He also confirmed that Zogenix is on track for submitting applications for regulatory approvals in the US and Europe in the second half of 2018.

As of now, ZX008 is designated as an orphan drug in the US as well as Europe. However, it has received the Fast Track designation in the US for the treatment of Dravet syndrome.

Last Close Stock Review

On Friday, September 29, 2017, the stock closed the trading session at $35.05, skyrocketing 172.23% from its previous closing price of $12.88. A total volume of 29.13 million shares have exchanged hands, which was higher than the 3-month average volume of 514.85 thousand shares. Zogenix’s stock price skyrocketed 141.72% in the last three months, 223.04% in the past six months, and 227.88% in the previous twelve months. Furthermore, since the start of the year, shares of the Company have soared 188.48%. At Friday’s closing price, the stock’s net capitalization stands at $319.66 million.

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