GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announced that it has commenced a Phase 3 clinical trial of Epidiolex® (cannabidiol or CBD) as an adjunctive therapy for the treatment of seizures associated with Tuberous Sclerosis Complex (TSC), a rare genetic disorder, the most common symptom of which is epilepsy. Epilepsy occurs in around 80-90% of TSC patients and is a significant cause of morbidity and mortality. TSC is the third indication that GW is targeting within its Epidiolex clinical development program, which includes four Phase 3 pivotal trials in Dravet syndrome and Lennox-Gastaut syndrome, both rare and catastrophic forms of childhood-onset epilepsy. On March 14, 2016, GW announced positive results from the first of these pivotal trials in Dravet syndrome.
“We are pleased to announce the start of this pivotal clinical trial of Epidiolex in TSC, which follows the recent positive results from our trial in patients with Dravet syndrome. Our decision to evaluate Epidiolex in TSC is based on findings from the physician-led Epidiolex expanded access program, which found that TSC patients reported reductions in seizure activity,” stated Justin Gover, GW’s Chief Executive Officer. “With the commencement of this trial, GW’s Epidiolex development program now encompasses three rare epilepsy indications with pivotal trials fully underway. GW is committed to establishing Epidiolex as a new therapy to address the significant unmet need among patients who have few treatment options.”
“In patients with TSC, epilepsy is common, presents early and can become more difficult to treat over time. The results of our open-label study of Epidiolex in children with TSC have been very encouraging and we are excited to begin this important placebo-controlled clinical trial,” stated Elizabeth Thiele, MD, PhD, Director, Pediatric Epilepsy Program at Massachusetts General Hospital, Director, Herscot Center for Tuberous Sclerosis Complex and Professor of Neurology, Harvard Medical School and Principal Investigator of the trial. “As one of the largest TSC treatment centers in the country, our focus has always been on finding new and innovative solutions that improve the lives of people living with TSC.”
At the 69th Annual Meeting of the American Epilepsy Society in December 2015, safety and efficacy data on 10 patients diagnosed with TSC from the physician-led open-label Epidiolex expanded access program were presented by Massachusetts General Hospital for Children (Geffrey et al 2015) on Epidiolex treatment of refractory epilepsy in these patients. The percent of patients who reported a 50% or greater reduction in seizures were 50%, 50%, 40%, 60% and 66% at 2, 3, 6, 9, and 12 months of treatment with Epidiolex, respectively. Side effects were seen in five patients (50%) and most were resolved with anti-epileptic drug or CBD dose adjustment.
This single Phase 3 dose-ranging trial is a 16-week comparison of Epidiolex versus placebo in a total of approximately 200 patients, aged one to 65, to assess its safety and efficacy as an adjunctive anti-epileptic treatment. The primary measure of this trial is the percentage change from baseline in seizure frequency during the treatment period. Primary endpoint seizures include focal motor seizures with or without impairment of consciousness or awareness and generalized convulsive seizures. Several additional efficacy and safety secondary outcome measures will be analysed. Following completion of the study, patients may be eligible to receive Epidiolex through a long term open-label extension study. (Original Source)
Shares of GWPH closed last Friday at $79.69, up $1.04 or 1.32%. GWPH has a 1-year high of $133.98 and a 1-year low of $35.83. The stock’s 50-day moving average is $60.85 and its 200-day moving average is $69.81.
On the ratings front, GWPH has been the subject of a number of recent research reports. In a report issued on March 21, Piper Jaffray analyst Joshua Schimmer reiterated a Buy rating on GWPH, with a price target of $147, which implies an upside of 84.5% from current levels. Separately, on March 15, Merrill Lynch’s Tazeen Ahmad reiterated a Buy rating on the stock and has a price target of $175.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Joshua Schimmer and Tazeen Ahmad have a total average return of -15.0% and 62.8% respectively. Schimmer has a success rate of 28.5% and is ranked #3779 out of 3788 analysts, while Ahmad has a success rate of 68.2% and is ranked #36.
The street is mostly Bullish on GWPH stock. Out of 6 analysts who cover the stock, 6 suggest a Buy rating . The 12-month average price target assigned to the stock is $162.00, which implies an upside of 103.3% from current levels.
GW Pharmaceuticals Plc engages in the business of discovering, developing and commercializing novel therapeutics from proprietary cannabinoid product platform in a broad range of disease areas. The company operates through the following segments: Commercial, Sativex Research & Development and Pipeline Research & Development. The Commercial segment promotes Sativex through strategic collaborations with major pharmaceutical companies for the currently approved indication of spasticity due to multiple sclerosis.