Edison increases valuation of GW Pharmaceuticals amid Epidiolex trial in Dravet syndrome

UK-based cannabinoid-focused pharma company GW Pharmaceuticals is entering an important phase of its business development, according to a report by investment analysts Edison.

The company has begun its first Phase III pivotal study for Epidiolex, an investigational cannabidiol, in Dravet syndrome, a treatment-refractory form of childhood epilepsy. This is the first of four planned Phase III trials with Epidiolex in different indications that are due to begin in the second quarter of 2015.

The pivotal trial underway is the second part of a two-part Phase II/III randomized, double-blind, placebo-controlled study of Epidiolex in Dravet syndrome in children already treated with other anti-epileptics. This part will recruit up to 100 new patients, given 20mg/kg daily for 14 weeks, with the primary efficacy endpoint as the percentage change from baseline in convulsive seizure frequency over the treatment period.