Economy

Zogenix's Dravet Syndrome Treatment Returns 'Strong' Results

Zogenix's Dravet Syndrome Treatment Returns 'Strong' Results”

Patients taking ZX008 0.2 mg/kg/day also showed a reduction in mean monthly convulsive seizures of 33.7% compared to placebo (P =.019). ZX008 has received orphan drug designation in the United States and European Union (EU), for the treatment of Dravet syndrome. The biotech hopes to win approval for its formulation of the drug in both the USA and Europe.

Not only did Zogenix nail its primary endpoint, but ZX008 also demonstrated statistically significant improvements versus the placebo in all key secondary measures, including the proportion of patients with clinically meaningful reductions in seizure frequency and longest seizure-free interval. Epidiolex is an oral drug created from plant-derived cannabidiol. For comparison, only 2.5% of patients in the placebo group achieved that level of benefit. Patients treated with Fen-Phen were found to be at greater risk of developing heart problems, including pulmonary hypertension.

Patients in the study were randomized to either a 0.8 mg/kg daily dose of ZX008, a 0.2 mg/kg daily dose or placebo. You might remember fenfluramine as part of the "fen-phen" obesity regimen that was pulled from the market in 1997 because fenfluramine (at a higher dose) caused severe damage to people's heart valves.

"Dravet syndrome is a rare, but catastrophic form of epilepsy that can be devastating for patients and their families", Joseph Sullivan, MD, director of the Pediatric Epilepsy Center in UCSF Benioff Children's Hospital San Francisco, and principal investigator of Study 1 in the U.S., said in a statement.

Details of the adverse events have not been provided by the company but they did note that the drug was generally well tolerated with the incidence of serious adverse events was similar in the 3 treatment groups [12.5% (n=5) in the 0.8 mg/kg/day group; 10.3% (n=4) in the 0.2 mg/kg/day group; and 10.0% (n=4) in the placebo group].

David and Tom just revealed what they believe are the 10 best stocks for investors to buy right now. and Zogenix wasn't one of them!

Management will host a conference call this morning at 8:30 am ET to discuss the results.

Additionally, an FDA filing for approval of ZX008 won't happen until a second Dravet syndrome confirms efficacy.

Based in Emeryville, California, the pharmaceutical company expects results from a second trial in the first half of next year. More than 25,644,298 shares have changed hands.

When investing geniuses David and Tom Gardner have a stock tip, it can pay to listen. His clients may have positions in the companies mentioned. The Motley Fool has a disclosure policy.



Like this

Latest


30 September 2017
Woman Has Both Eyes Ripped Out And Is Stabbed Wednesday Night
One man has been arrested after police say he ripped out a woman's eyes in a gruesome attack. He says Roberson was sitting on top of the woman, using only his hands to destroy her face.

30 September 2017
North Korean firms in China ordered to close by January
But the latest sanctions need time before they begin to bite, the official China Daily cautioned in an editorial on Friday. However, they are also expected to talk about the pressing, global matter of North's nuclear and missile programs.

30 September 2017
Bristol-Myers Squibb Company (BMY) Shares Sold by Fisher Asset Management LLC
The biopharmaceutical company reported $0.74 earnings per share for the quarter, beating the consensus estimate of $0.73 by $0.01. Following the completion of the transaction, the director now directly owns 18,000 shares in the company, valued at $1,006,920.

30 September 2017
Lion does Cheetahs a favour after bite rules out Ospreys' Baldwin
Scott Baldwin is an early contender for the most freakish injury of the year after being bitten by a lion in Bloemfontein. The Ospreys hooker was forced to miss his side's game after the beast attacked him in South Africa.

30 September 2017
International Business Machines Corporation (NYSE:IBM) Rating Reiterated by Jefferies Group LLC
On Tuesday, July 19 the stock rating was maintained by UBS with "Neutral". (NYSE:IBM) on Tuesday, April 19 with "Neutral" rating. AVP share have plunged by -52.58% in percentage terms since the start of the year - and retreated -6.27% in the last month.

30 September 2017
Jury deliberating in Oklahoma beheading case
After that, the state is tasked with getting the jury to choose the punishment they think Nolen deserves - the death penalty. Defense attorneys argue that Nolen was insane when he killed his co-worker.

30 September 2017
No. 15 Oklahoma State looking to rebound at Texas Tech
It will take everything we have to play well enough to play this Saturday, so I think that helps them focus". The Cowboys start the season with a road series against Texas State on February 16-18.

30 September 2017
San Francisco and New York Giants legend Willie Mays honored by Major League Baseball
At the 2015 All-Star Game in Cincinnati, Mays was voted by the fans as one of Major League Baseball's "Four Greatest Players". He remains with the Giants organization in San Francisco and still attends most of the games.

30 September 2017
5.4 magnitude quake hits China, no casualties reported
Qingchuan was also one of the worst-hit areas when an 8.0-magnitude quake struck Sichuan's Wenchuan County on May 12, 2008. The world's deadliest natural disaster hit central and eastern part of China in 1556 leaving about 830,000 people dead.

30 September 2017
Huskers use big first half to pick up road win over IL
Nebraska's offense got the ball back and Lee again led a scoring drive, and he was a ideal 5-for-5 on the drive for 52 yards. The Scarlet Knights got on the board first with an 11-play drive, followed by a Cornhusker seven-play drive to tie it 7-7.



Recommended