GW Pharma shares more than double after positive Phase III trials for epilepsy drug
pharmafile | March 15, 2016 | News story | Manufacturing and Production, Research and Development | Epidiolex, GW Pharma, US FDA, epilepsy in children, phase III
Shares in UK-based GW Pharmaceuticals (Nasdaq: GWPH) more than doubled on the Nasdaq Monday after the company announced positive results for late-stage trials for its trial drug Epidiolex (cannabidiol or CBD) to treat Dravet syndrome, a rare and severe form of epilepsy in children.
The company said Phase III trials for its trial drug Epidiolex met the primary endpoint of a significant reduction in convulsive seizures assessed.
Epidiolex has both Orphan Drug Designation and Fast Track Designation from the US Food and Drug Administration (FDA) in the treatment of Dravet syndrome, a rare and debilitating type of epilepsy for which there are currently no treatments approved in the US.
Justin Gover, GW’s chief executive, said: “The positive outcome of this Phase III trial is a significant milestone in the development of Epidiolex as a potential new treatment for patients suffering with 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. In light of this positive data, we will now request a pre-NDA meeting with the FDA to discuss our proposed regulatory submission. We also look forward with excitement to the upcoming results from the two Phase III trials in Lennox-Gastaut syndrome and the second pivotal trial in Dravet syndrome.”
Further data will be presented in future publications and medical meetings, the company said in a statement.
Mary Anne Meskis, Executive Director of the Dravet Syndrome Foundation, said: “Dravet syndrome is one of the most catastrophic types of epilepsy in children and safe and effective treatments are desperately needed. We are thrilled to learn of these positive results, which bring much needed hope to the children and families who have been living with these debilitating seizures.”
In addition to this first Phase III trial, GW is conducting a second Phase III trial in Dravet syndrome.
The company is also conducting clinical trials in Lennox-Gastaut syndrome, another rare and severe form of epilepsy. The first Phase III trial is a placebo-controlled trial of Epidiolex over a 14 week treatment period and has randomized 171 patients. The trial results are expected in the second quarter of 2016.
The primary measure of efficacy in these two trials will be the comparison between Epidiolex and placebo in the percentage change in number of monthly drop seizures during the 14-week treatment period compared with the 4-week baseline observation period.
Shares in GW Pharma closed up $46.25 at $84.71 Monday, on the Nasdaq.
Anjali Shukla
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