GW Pharmaceuticals plc (GWPH) continues to lead the medical cannabis movement…
This morning, the company reported its second positive Stage 3 Clinical trial for its Epidiolex product for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS).
This trial follows the announcement in June 2016 of positive results in the first pivotal Phase 3 trial of Epidiolex for the treatment of seizures associated with LGS, and the March 2016 announcement of positive results in the treatment of seizures associated with Dravet syndrome.
GW continues to executes on its robust pipeline of products in various stages of FDA testing and the company expects to submit a New Drug Application (NDA) in the first half of 2017.
Report Silences the Critics
This report could not come at a more perfect time as investors started to doubt the legitimacy behind any potential acquisition rumors, which were reported in early September.
GW Pharmaceuticals continues to make advancements in its pipeline of cannabinoid products. The company has a deep pipeline of products that are in various stages of FDA testing.
GWPH is trading north of $120 a share during pre-market trading and we continue to view the company as a top pick due to its: 1) It has a deep pipeline of products that are various stages of FDA testing, 2) its strong management team who continues to execute, 3) it’s the only pure-play cannabis biotech company, and 4) it is trading below the average Wall Street price target.
About the Study
The Phase 3 study randomized 225 patients into three arms. Some patients took 20mg of Epidiolex, while other took 10mg of Epidiolex or a placebo. On average, patients were taking approximately three anti-epileptic drugs (AEDs), having previously tried and discontinued an average of seven other AEDs. The average age of trial participants was 16 years and the median drop seizure frequency over the 4-week baseline period was 85.
The primary efficacy endpoint of this trial was a comparison between Epidiolex and placebo in the percentage change in the monthly frequency of drop seizures during the 14-week treatment period compared to the 4-week baseline period before randomization.
Epidiolex achieved its primary endpoint for both dose levels with high statistical significance in this trial as patients achieved a median reduction in monthly drop seizures of 42% compared with a reduction of 17% in patients taking a placebo. Patients who were taking a smaller dosage of Epidiolex also saw a median reduction in monthly drop seizures of 37% compared with a reduction of 17% in patients taking a placebo.
Safety Data is Consistent
A series of sensitivity analyses of the primary endpoint for both dose groups confirmed the robustness of these results. In both dose groups, the difference between Epidiolex and placebo emerged during the first month of treatment and was sustained during the entire treatment period.
Epidiolex was generally well tolerated in this trial as the pattern of adverse events was consistent with previously reported results in the previous two Phase 3 studies.
The most common adverse events were somnolence, decreased appetite, upper respiratory infection, diarrhea, and status epilepticus. Of the patients who completed this trial, 99% have opted to continue into an open-label extension trial.
New Drug Application for Epidiolex is on Track
Following the success of the first Dravet syndrome Phase 3 trial earlier this year, GW requested a pre-NDA meeting with the FDA to discuss a proposed Dravet syndrome NDA. This meeting took place in July 2016 and also included some discussion of data from the first Phase 3 LGS trial.
GW believes the guidance received enables the company’s proposed filing strategy to submit a single NDA that includes Phase 3 data from one Dravet trial and two LGS trials, which remains on track for a submission in the first half of 2017. GW now anticipates a simultaneous decision on both indications and does not expect to wait for results from the second trial in Dravet syndrome prior to this submission.
In order to support GW’s NDA, the company expects to provide the FDA with data from ten Phase 1 and Phase 2 studies, as well as safety data in over 1,800 patients from both the expanded access program and pivotal programs, including over 450 patients with one year or more of Epidiolex continuous exposure.
Pursing Other Indications
GW is currently conduction clinical trial programs in Dravet Syndrome, Tuberous Sclerosis Complex and Infantile Spasms.
In March 2016, GW announced positive results of the first pivotal Phase 3 trial of Epidiolex in Dravet syndrome. GW continues to enroll a second Phase 3 trial of Epidiolex in Dravet syndrome and will report these results upon completion.
GW has commenced a Phase 3 trial of Epidiolex in Tuberous Sclerosis Complex and expects to initiate a Phase 3 trial of Epidiolex in Infantile Spasms in the fourth quarter of this year.
Acquisition Costs Increase Post-Results
We continue to view GW Pharmaceutical as the top investment opportunity within the cannabis sector as it is the only company that trades on the Nasdaq which is focused on developing treatments from the actual cannabis plan.
Unlike Zynerba Pharmaceuticals (ZYNE) and Insys Therapeutics (INSY), which develop its treatments from synthetic cannabis; GW actually uses the actual cannabis plant and the benefits of this are shown through its continued success in FDA trials.
Although nothing has been announced on a potential acquisition of GWPH, the company’s valuation has certainly improved following this positive test and we continue to remain favorable on the shares!