GW Pharma's Epidiolex meets Phase III endpoint in LGS

UK biopharma company GW Pharmaceuticals (AIM: GWP) today announced positive results of the second randomized, double-blind, placebo-controlled Phase III clinical trial of its investigational medicine Epidiolex (cannabidiol or CBD) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy.

GW Pharmaceuticals is now on track to file the drug with US regulators in the first half of 2017, and the news sent the firm’s shares soaring 13% to 790 pence by late afternoon trading. Epidiolex has the potential to be a breakthrough medication for children with rare forms of epilepsy, for whom there are no effective treatments.

In this trial, Epidiolex, when added to the patient’s current treatment, achieved the primary endpoint for both dose levels with high statistical significance. During the treatment period, patients taking Epidiolex 20mg/kg/day achieved a median reduction in monthly drop seizures of 42% compared with a reduction of 17% in patients taking placebo (p=0.0047), and patients taking Epidiolex 10mg/kg/day achieved a median reduction in monthly drop seizures of 37% compared with a reduction of 17% in patients on placebo (p=0.0016).