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GW Pharmaceuticals Stock Up on Positive Epidiolex Data
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GW Pharmaceuticals plc’s shares were up 6.2% after the company announced positive data from the first phase III study on its lead cannabinoid candidate, Epidiolex, for the treatment of Lennox-Gastaut syndrome (LGS).
The randomized, double-blind placebo-controlled study evaluated Epidiolex in patients (aged 2 years to 55 years) with a confirmed diagnosis of drug-resistant LGS currently uncontrolled on one or more concomitant anti-epileptic drugs (AEDs). Patients (n=171) were randomized into two arms – Epidiolex 20mg/kg/day or placebo, each receiving the current AED treatment.
Data from the study revealed a statistically significant reduction in the monthly frequency of drop seizures compared to placebo when assessed over 14 weeks of treatment, thereby meeting the primary endpoint. In addition, Epidiolex was generally well tolerated.
Meanwhile, the company has completed patient enrolment in the second phase III dose-ranging study on Epidiolex for the treatment of LGS. The study has three treatment arms – Epidiolex 20mg/kg/day, Epidiolex 10mg/kg/day and placebo. Top-line results from the study are expected around the end of the third-quarter 2016.
LGS, a rare kind of epilepsy, starts showing symptoms in patients between 3-5 years of age. According to information provided by the company, there are about 14,000–18,500 individuals suffering from LGS in the U.S., and 23,000–31,000 people with the disease in Europe.
We remind investors that in Mar 2016, the company announced positive data from a phase III study on Epidiolex for the treatment of Dravet syndrome. The company is now looking to submit a New Drug Application in the U.S. for the candidate in the first half of 2017.
In the U.S., Epidiolex, enjoys Fast Track designation for the treatment of Dravet syndrome, and Orphan drug status for the treatment of Dravet syndrome, LGS, tuberous sclerosis complex and infantile spasms. The candidate also enjoys Orphan Designation in the EU for the treatment of Dravet syndrome.
Epidiolex is also being evaluated in a phase III study for the treatment of tuberous sclerosis complex. Further, the company expects to initiate a phase III study on Epidiolex in infantile spasms in the fourth quarter of this year.
We expect investor focus to remain on further updates by the company on the development of Epidiolex.
GW Pharma currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include ANI Pharmaceuticals, Inc. (ANIP - Free Report) , Bristol-Myers Squibb Company (BMY - Free Report) and Pfizer Inc. (PFE - Free Report) , each sporting a Zacks Rank #1 (Strong Buy).
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GW Pharmaceuticals Stock Up on Positive Epidiolex Data
GW Pharmaceuticals plc’s shares were up 6.2% after the company announced positive data from the first phase III study on its lead cannabinoid candidate, Epidiolex, for the treatment of Lennox-Gastaut syndrome (LGS).
The randomized, double-blind placebo-controlled study evaluated Epidiolex in patients (aged 2 years to 55 years) with a confirmed diagnosis of drug-resistant LGS currently uncontrolled on one or more concomitant anti-epileptic drugs (AEDs). Patients (n=171) were randomized into two arms – Epidiolex 20mg/kg/day or placebo, each receiving the current AED treatment.
Data from the study revealed a statistically significant reduction in the monthly frequency of drop seizures compared to placebo when assessed over 14 weeks of treatment, thereby meeting the primary endpoint. In addition, Epidiolex was generally well tolerated.
Meanwhile, the company has completed patient enrolment in the second phase III dose-ranging study on Epidiolex for the treatment of LGS. The study has three treatment arms – Epidiolex 20mg/kg/day, Epidiolex 10mg/kg/day and placebo. Top-line results from the study are expected around the end of the third-quarter 2016.
LGS, a rare kind of epilepsy, starts showing symptoms in patients between 3-5 years of age. According to information provided by the company, there are about 14,000–18,500 individuals suffering from LGS in the U.S., and 23,000–31,000 people with the disease in Europe.
We remind investors that in Mar 2016, the company announced positive data from a phase III study on Epidiolex for the treatment of Dravet syndrome. The company is now looking to submit a New Drug Application in the U.S. for the candidate in the first half of 2017.
In the U.S., Epidiolex, enjoys Fast Track designation for the treatment of Dravet syndrome, and Orphan drug status for the treatment of Dravet syndrome, LGS, tuberous sclerosis complex and infantile spasms. The candidate also enjoys Orphan Designation in the EU for the treatment of Dravet syndrome.
Epidiolex is also being evaluated in a phase III study for the treatment of tuberous sclerosis complex. Further, the company expects to initiate a phase III study on Epidiolex in infantile spasms in the fourth quarter of this year.
We expect investor focus to remain on further updates by the company on the development of Epidiolex.
GW Pharma currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include ANI Pharmaceuticals, Inc. (ANIP - Free Report) , Bristol-Myers Squibb Company (BMY - Free Report) and Pfizer Inc. (PFE - Free Report) , each sporting a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>