GW to trial cannabinoid therapy on infantile spasms

The AIM-traded firm, which focuses on discovering, developing and commercialising therapeutics from its proprietary cannabinoid product platform, said that the US Food and Drug Administration has also granted Orphan Drug Designation for Epidiolex, for the treatment of IS.

GW’s board said it expects to commence a two-part pivotal Phase 3 study in the fourth quarter of 2016.

“We are pleased to add infantile spasms as a fourth target indication for Epidiolex, demonstrating GW's ongoing commitment to addressing the significant unmet medical need within the field of pediatric epilepsy,” said Justin Gover, CEO of GW Pharmaceuticals.

“Currently, there are limited treatment options for children suffering from infantile spasms and outcomes for patients with the disorder include higher mortality, ongoing development of additional seizure disorders as the patient matures, and often severe cognitive and developmental delay.”

Epidiolex is already being developed in three other orphan indications within the field of pediatric epilepsy - Dravet syndrome, Lennox-Gastaut syndrome and Tuberous Sclerosis Complex.

In March, GW announced positive results from the first Phase 3 trial in Dravet syndrome, with results from the first Phase 3 trial in Lennox-Gastaut syndrome expected this month.