GW Pharma succeeds with second epilepsy trial for Epidiolex

GW Pharmaceuticals has revealed its cannabis-derived treatment has been found to reduce seizures for two forms of epilepsy.

Phase III pivotal trials for its Epidiolex drug in the treatment of Lennox-Gastaut Syndrome, a rare and severe form of childhood-onset epilepsy, achieved the primary endpoint of producing a significant reduction in the monthly frequency of drop seizures compared with placebo over the 14-week treatment period of the trial.

GW's success with the Lennox-Gastaut trial follows similar positive results in the pivotal Phase 3 trial of Epidiolex for the treatment of Dravet syndrome.

GW, which has won Orphan Drug status from the US Food and Drug Administration (FDA) for the treatment of the two syndromes, said it aims to make a new drug application (NDA) submission with the FDA for Epidiolex "in the first half of 2017".

Chief executive Justin Gover said the company was particularly pleased that this result was consistent with the Dravet trial as the result "further demonstrates that Epidiolex offers the potential to be a new effective therapy within the field of treatment-resistant childhood-onset epilepsies".

Linda Laux, MD, director of the Comprehensive Epilepsy Center at the Lurie Children's Hospital of Chicago and assistant professor of pediatrics, Northwestern University Feinberg School of Medicine, said the data "show that Epidiolex has the potential to provide a robust and clinically meaningful reduction in seizures in this highly treatment-resistant population together with an acceptable safety and tolerability profile".

The trial was conducted among 171 patients aged 2-55 years with a confirmed diagnosis of drug-resistant LGS currently uncontrolled on one or more concomitant anti-epileptic drugs. The primary efficacy endpoint of the randomized, double-blind placebo-controlled was a comparison between Epidiolex and placebo in the percentage change in the monthly frequency of drop seizures during the 14 week treatment period - a two-week dose escalation period followed by 12 weeks of maintenance - compared to the four-week baseline period before randomization.

GW shares surged 26% to 636.05p, their highest point since July last year.