GW Pharmaceuticals plc (GWPH) has once again changed the landscape of the cannabis industry as the company reported its second positive Stage 3 Clinical trial for its Epidiolex product.
The results for this trial were for the treatment of Lennox-Gastaut syndrome (LGS) and Epidiolex was able to significantly reduce the number of drop seizures over a 14-week period when compared to a placebo.
In this study, Epidiolex achieved the primary endpoint of a significant reduction in drop seizures assessed over the entire treatment period compared with a placebo. Epidiolex has both Orphan Drug Designation and Fast Track Designation from the FDA.
Significant Drop in Number of Seizures
The difference between Epidiolex and a placebo emerged during the first month of treatment and was sustained during the entire treatment period.
During the treatment, patients taking Epidiolex achieved a median reduction in monthly drop seizures of 44% compared with a reduction of 22% in patients receiving placebo, a difference that was considered to be statistically significant.
Future Catalysts Ahead
GW Pharmaceuticals CEO Justin Gover said the company is looking forward to advancing Epidiolex toward the submission of a New Drug Application with the FDA in the first half of 2017.
GW Pharmaceuticals said it is conducting a second Phase 3 dose-ranging trial of Epidiolex for the treatment of LGS, which is fully enrolled at 225 patients.
The second trial has three treatment arms and the company expects to report top-line results from this trial toward the end of the third quarter of this year.
Continues to Execute
This trial follows the announcement in March 2016 of positive results in a pivotal Phase 3 trial of Epidiolex for the treatment of Dravet syndrome.
GWPH is trading above $95 this morning after the shares fell more than 6.5% on Friday. We continue to remain favorable on the company and Technical420 will continue to hold onto shares in its mock portfolio.