|GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) starts Second Phase 3 Pivotal Study of Epidiolex|
|By Josh Gee|
|Thursday, 11 June 2015 15:00|
GW Pharmaceuticals PLC- ADR(NASDAQ:GWPH), which is focussed on developing as well as commercialising novel therapeutics from proprietary cannabinoid product platform has started second of two Phase 3 clinical trials of Epidiolex which treats Lennox-Gastaut syndrome. The LGS is a rare and severe form of childhood-onset epilepsy.
GW had got Orphan Drug Designation in 2014 from U.S. Food and Drug Administration (FDA) for Epidiolex for which the top-line data would be available by first quarter of 2016.
Justin Gover, GW's Chief Executive Officer , opined that the starting of the trial has led to GW's pivotal program of Phase 3 trials for Epidiolex in Dravet syndrome.
Gover added that long-term prognosis for Lennox-Gastaut syndrome patients is bad in seizure control as well as cognitive development along with patients have continued seizure activity into adulthood.
The trial program consists of studies which has randomized and 14-week comparison of Epidiolex versus placebo. The treatment has two-week titration period after which there is a 12-week maintenance period.
A single Phase 3 trial has two arms of 50 patients while second study also has low dose treatment arm which means 150 patients.
The primary measure of effectiveness would be comparison between Epidiolex and placebo and number of drop seizures. Some more efficacy as well as safety secondary outcome measures would be analysed. After participation in studies, all patients would be able to get Epidiolex under long term open label extension study.
Besides this, GW has confirmed plans to develop Epidiolex in third target indication along with Tuberous Sclerosis Complex, a rare pediatric genetic disorder. The firm is expecting commencement of a TSC Phase 3 clinical program in the second half of 2015.