Zogenix, Inc. (ZGNX - Free Report) announced successful completion of its second confirmatory phase III study (Study 1504) evaluating its pipeline candidate, ZX008 (low-dose fenfluramine hydrochloride), for treating Dravet syndrome, a type of epilepsy in children and young adults.
The data was consistent with the positive results observed in the first pivotal phase III study in reducing monthly convulsive seizures.
Shares of Zogenix rallied 20.7% following the announcement. The company’s shares have increased 39.6% so far this year, outperforming the industry’s gain of 2.2%.
The two phase III studies – Study 1 and Study 1504 – were conducted for a planned new drug application seeking approval of ZX008 for the treatment of Dravet syndrome.
The phase III study – study 1504 – evaluated ZX008 in patients who were on stable background regimen of stiripentol plus other antiepileptic drugs compared to placebo. Data showed that 0.5 mg/kg/day (maximum 20 mg/day) dosage of ZX008 accounted for drug-drug interaction with stiripentol and achieved superiority over placebo.
Patients treated with ZX008 had 54.7% better reduction in mean monthly convulsive seizures versus placebo which was the primary endpoint of the study. The median reduction achieved by ZX008 in reducing monthly convulsive seizure frequency was 62.7% compared to 1.2% for placebo.
The encouraging results achieved by ZX008 demonstrate the potential of the candidate to make significant impact on patients who have uncontrolled convulsive seizures after treatment with stiripentol, the standard of care for treating Dravet syndrome in Europe.
A potential approval will boost the company’s top line as it holds potential to become new the standard of care.
The drug enjoys orphan drug designation in both the United States and Europe. The FDA has also granted the candidate breakthrough therapy designation for Dravet syndrome.
We remind investors that GW Pharmaceuticals PLC’s (GWPH - Free Report) Epidiolex was approved by the FDA last month for the treatment of Dravet syndrome and is under review in Europe. Insys Therapeutics, Inc.’s cannabidiol candidate also enjoys orphan drug status for Dravet syndrome in the United States.
Zacks Rank & Stock to Consider
Zogenix currently carries a Zacks Rank #3 (Hold). Summit Therapeutics PLC (SMMT - Free Report) is a better-ranked stock in the same space, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Summit’s loss estimates have narrowed from $2.34 to $1.67 for 2018 and from $3.03 to $1.70 for 2019 in the past 30 days. The company delivered positive earnings surprise in two of the trailing four quarters with an average beat of 9.35%.
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