|GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) starts Phase 3 Pivotal Study of Epidiolex|
|By Josh Gee|
|Monday, 11 May 2015 15:07|
Biopharmaceutical firm GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) has confirmed starting of Phase 3 clinical trial of Epidiolex for treating Lennox-Gastaut syndrome, a rare and severe form of childhood-onset epilepsy.
The firm got Orphan Drug Designation from U.S. Food and Drug Administration for Epidiolex in 2014. However, the top-line data from the trial would be available in early 2016.
Justin Gover, GW's Chief Executive Officer, opined that the starting of the trial in Lennox-Gastaut syndrome follows on from latest start of two Phase 3 pivotal trials of Epidiolex in Dravet syndrome along with the firm’s planned submission of NDA to the FDA in 2016. He added that Epidiolex has potential to meet significant unmet need.
The Phase 3 pivotal trial is a 14-week comparison of Epidiolex vis-a-vis placebo in total of 150 patients for assessing dose-ranging safety and efficiency of Epidiolex as an antiepileptic treatment.
The treatment period would be two-week titration period and would be having three arms of 50 patients. The first measure of the trial would be percentage change from baseline in number of drop seizures in patients.
Some other efficacy outcomes would also be analysed. LGS usually start before 4 years of age and may be a result of conditions such as brain malformations, central nervous system infections, severe head injuries and inherited degenerative conditions.
About 30 to 35 percent of patients have no cause. Patients have frequent seizures of a large number of convulsive as well as atonic seizures.
Most children having LGS witness slight impaired intellectual functioning besides developmental delays and behavioural disturbances. There are about 14,000-18,500 patients having LGS in United States and 23,000-31,000 patients with LGS in Europe.