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GW Pharmaceuticals Begins Another Phase III Epidiolex Trial

GW Pharmaceuticals plc GWPH announced that it has initiated a phase III study on its lead cannabinoid candidate, Epidiolex, for the treatment of seizures associated with tuberous sclerosis complex (TSC).

The dose-ranging study will evaluate the safety and efficacy of Epidiolex as an adjunctive antiepileptic treatment, in comparison to placebo, for 16 weeks. A total of approximately 200 patients, aged between 1 to 65 years, will be enrolled in the study. The primary endpoint is the change from baseline in seizure frequency during the treatment period.

According to information provided by the company, approximately 50,000 individuals in the U.S. and nearly 1 million individuals in the world are suffering from TSC. Moreover, up to 80–90% of TSC patients are likely to develop epilepsy in their lifetimes, which is the most common presenting symptom of the disease.

We note that Epidiolex is being developed for the treatment of a number of rare pediatric epilepsy disorders. Currently, GW Pharma is evaluating the candidate in four phase III studies for Dravet syndrome and Lennox-Gastaut syndrome. Last month, the company has announced positive data from the first phase III study in Dravet syndrome. Results from the second phase III study are expected in the second half of this year. In addition, data from the two remaining phase III studies in Lennox-Gastaut syndrome are expected in the second quarter of 2016.

Meanwhile, the company expects to begin additional clinical development of Epidiolex in the second half of 2016, and file a New Drug Application for the candidate in the fourth quarter of the year.

We remind investors that 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 and Lennox-Gastaut syndrome. The candidate also enjoys Orphan Designation for the treatment of Dravet syndrome in the EU.

GW Pharma currently has a Zacks Rank #2 (Buy). Other favorably placed stocks in the health care sector include AMAG Pharmaceuticals, Inc. AMAG, Anika Therapeutics Inc. ANIK and Emergent BioSolutions, Inc. EBS,  each sporting a Zacks Rank #1 (Strong Buy).

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