On February 25th 2016, Edison Investments opined in a research report on GW Pharmaceuticals PLC : With four Phase III trials of Epidiolex (cannabidiol or CBD) in various forms 25 February 2016 of pediatric epilepsy, two for Dravet syndrome and two for Lennox-Gastaut syndrome (LGS) expected to provide top-line readouts in 2016 (with three in H116), investors are understandably laser-focused on these programmes. Based on an analysis of the previous results of other molecules in Dravet and LGS, as well as data from the expanded access programme, we are confident that the trials are sufficiently powered to demonstrate a statistically significant benefit for those patients taking Epidiolex.
That was an understatement! The GW Pharmaceuticals PLC stock soared 120% in today’s market trading on positive phase 3 data.
GW Pharmaceuticals PLC – On the management call the CEO of stated:
If approved, Epidiolex would be the first FDA-approved treatment for Dravet syndrome and would represent an exciting new class of anti-seizure drug that offers the potential for meaningful seizure management in otherwise treatment-resistant patients in the setting of a well-tolerated safety profile. This, we believe, is the unique proposition of Epidiolex.
Also with these results, we believe the physician-led US expanded access program has clearly turned out to be a good predictor of Epidiolex effect. Those insights from the expanded access program have led GW forward regarding our future development plans, which include Lennox-Gastaut syndrome, tuberous sclerosis complex, and additional targets in the field of childhood onset epilepsy that we expect to announce later this year. We believe that today’s trial results support our confidence regarding the outcome of trials in these other pediatric epilepsy conditions.
Morgan Stanley analysts opined on the GW Pharmaceuticals PLC news:
Bear thesis largely debunked. We think that much of the bear thesis has been proven overstated. While the placebo rate was slightly higher than historical trials, it was not as high as some investors expected. Similarly, the efficacy rate from this trial was slightly lower than that seen previously in the expanded access program, but definitively proves that the drug has an effect on patients refractory to multiple other medications. We believe the ability to up titrate the drug is likely to provide higher efficacy in the real world.
Disclosed data are impressive, but some skepticism likely to remain until full data are presented.
Only time will tell!