14th Mar 2016 11:44
LONDON (Alliance News) - Shares in GW Pharmaceuticals PLC more than doubled in price on Monday after the company reported positive results from a key late stage study of its flagship treatment epidiolex in Dravet syndrome, a rare form of childhood epilepsy.
Shares in the company were up 234.25 pence at 450.75p, their highest level since December. The stock was easily the best performer on AIM.
GW Pharmaceuticals said it achieved its primary endpoint in the study of a "significant reduction" in convulsive seizures compared with a placebo.
Epidiolex has both an orphan drug designation, and a fast designation from the US Food and Drug Administration in the treatment of Dravet syndrome, and is also being assessed in late stage trials for Lennox-Gastaut syndrome, also another rare form of epilepsy, and soon in a third epilepsy indication, Tuberous Sclerosis Complex.
The trial results come as positive news after late stage trials of the company's Sativex drug for the treatment of pain in patients with advanced cancer failed to meet their primary endpoint last year.
"The positive outcome of this Phase 3 trial is a significant milestone in the development of Epidiolex as a potential new treatment for patients suffering from Dravet syndrome. We are excited about the potential for Epidiolex to become the first FDA approved treatment option specifically for Dravet syndrome patients and their families," said Chief Executive Officer Justin Gover in a statement.
GW Pharmaceuticals said that, in light of the positive phase III data, it will now request a pre-new drug application meeting with the US FDA to discuss its proposed regulatory submission. The company is conducting a second phase III trial in Dravet syndrome, and is currently recruiting patients.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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