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 commenced the second of two Phase 3 clinical trials of Epidiolex® (cannabidiol or CBD) for the treatment of Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy. During 2014, GW received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for Epidiolex for the treatment of LGS. GW anticipates that top-line data from this trial will be available in the first quarter of 2016.
“With the commencement of this trial, GW’s pivotal program of four Phase 3 trials for Epidiolex in Dravet syndrome and Lennox-Gastaut syndrome is now fully underway,” stated Justin Gover, GW’s Chief Executive Officer. “The long-term prognosis for Lennox-Gastaut syndrome patients is poor in terms of seizure control and cognitive development and patients typically have continued seizure activity into adulthood. GW is committed to bringing Epidiolex to patients as a new option to address this significant unmet need.”
The LGS Phase 3 pivotal trial program comprises two studies, both of which comprise a randomized, double-blind, 14-week comparison of Epidiolex versus placebo. The treatment period consists of a two-week titration period followed by a 12-week maintenance period. One Phase 3 trial has two arms of 50 patients; 20mg/kg and placebo, whereas the second study also includes a low dose treatment arm, and therefore includes a total of 150 patients. The primary measure of efficacy in both trials will be the comparison between Epidiolex and placebo in the percentage change from baseline in number of drop seizures. Several additional efficacy and safety secondary outcome measures will be analysed. Following their participation in the studies, all patients are eligible to receive Epidiolex under a long term open label extension study.
In addition to the Epidiolex clinical programs in LGS and Dravet syndrome, GW has also announced plans to develop Epidiolex in a third target indication, Tuberous Sclerosis Complex, a rare pediatric genetic disorder, the most common symptom of which is epilepsy. GW expects to commence a TSC Phase 3 clinical program in the second half of 2015. (Original Source)
Shares of GW Pharmaceuticals closed yesterday at $120.86 . GWPH has a 1-year high of $128.25 and a 1-year low of $58.16. The stock’s 50-day moving average is $114.68 and its 200-day moving average is $89.90.
On the ratings front, GW Pharmaceuticals has been the subject of a number of recent research reports. In a report issued on April 22, Piper Jaffray analyst Joshua Schimmer reiterated a Buy rating on GWPH, with a price target of $147, which represents a potential upside of 21.6% from where the stock is currently trading. Separately, on April 14, Leerink Swann’s Joseph Schwartz reiterated a Buy rating on the stock and has a price target of $120.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Joshua Schimmer and Joseph Schwartz have a total average return of 16.1% and 33.3% respectively. Schimmer has a success rate of 66.7% and is ranked #140 out of 3621 analysts, while Schwartz has a success rate of 69.4% and is ranked #42.
GW Pharmaceuticals PLC is engaged in the research, development and commercialisation of cannabinoid prescription medicines to meet patient needs.