GW Pharmaceuticals PLC-ADR (NASDAQ:GWPH), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced that it has initiated the second Phase 3 clinical trial of Epidiolex® (cannabidiol or CBD) for the treatment of Dravet syndrome, a rare and catastrophic treatment-resistant form of childhood epilepsy. This follows GW’s recent announcement of the commencement of the first Phase 3 clinical trial of Epidiolex in Dravet syndrome. GW expects to complete patient recruitment into this second trial in 2015 and to report top-line results in early 2016.
“The start of our second pivotal Phase 3 clinical trial for Epidiolex in the treatment of Dravet syndrome marks another key milestone in our plan to submit a New Drug Application for Epidiolex to the FDA in mid-2016,” stated Justin Gover, GW’s Chief Executive Officer. “Therapeutic options for patients with Dravet syndrome are limited and GW is committed to bringing Epidiolex to the market as quickly as possible and to offering a new option to address this significant unmet need.”
The Phase 3 trial is a 14-week comparison of Epidiolex versus placebo in a total of 150 patients to assess the safety and efficacy as an adjunctive antiepileptic treatment. This Phase 3 trial will have three treatment arms of equal patient numbers; 20mg/kg of Epidiolex, 10mg/kg of Epidiolex, and placebo. The primary measure of this trial will be the percentage change from baseline in convulsive seizure frequency during the maintenance period of the study in patients taking Epidiolex versus placebo. Several additional efficacy and safety secondary outcome measures will be analysed. Following their participation in the study, all patients are eligible to receive Epidiolex under a long term open label extension study.
GW also expects to commence two Phase 3 clinical trials in Lennox-Gastaut syndrome in the second quarter of 2015.
Shares of GW Pharmaceuticals closed yesterday at $113.5 . GWPH has a 1-year high of $116.42 and a 1-year low of $44.60. The stock’s 50-day moving average is $92.53 and its 200-day moving average is $79.11.
On the ratings front, GW Pharmaceuticals has been the subject of a number of recent research reports. In a report issued on April 14, Leerink Swann analyst Joseph Schwartz reiterated a Buy rating on GWPH, with a price target of $120, which represents a potential upside of 5.7% from where the stock is currently trading. Separately, on April 8, Piper Jaffray’s Joshua Schimmer reiterated a Buy rating on the stock and has a price target of $147.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Joseph Schwartz and Joshua Schimmer have a total average return of 32.9% and 17.1% respectively. Schwartz has a success rate of 66.7% and is ranked #44 out of 3575 analysts, while Schimmer has a success rate of 66.3% and is ranked #174.
In total, 6 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $113.5 which is 2.6% above where the stock closed yesterday.
GW Pharmaceuticals PLC is engaged in the research, development and commercialisation of cannabinoid prescription medicines to meet patient needs.