GW Pharmaceuticals (GWPH) Announces Positive Results for Phase 3 Pivotal Trial for Epidiolex, Shares Soar

Shares of GW Pharmaceuticals Plc (GWPH) were trading up +13.45 or +12.50 percent to $121.01 per share in Monday’s premarket after the company announced that Epidiolex had reached positive results in a Phase 3 pivotal trial for Epidiolex (cannabidiol) in the treatment of Lennox-Gastaut Syndrome. GW Pharmaceutical stock closed at $107.56 per share, down -2.20 or -2.00 percent in Friday’s regular trading session.

Stock Analysis

Wiltshire, UK based GW Pharmaceuticals plc is a biopharmaceutical company founded in 1998.
The company is best known for its development and marketing of multiple sclerosis drug nabiximols, known under the brand name Sativex. Sativex is produced using a derivative of the cannabis plant and is the first cannabis based medication to gain full approval in any country and is used for the treatment of spasticity due to multiple sclerosis. After GW Pharmaceuticals was given a Fast Track designation to speed up its development program for Epidiolex, a treatment for Dravet syndrome, a rare form of childhood epilepsy, the treatment underwent 3 clinical trials last year.
GW Pharmaceuticals (GWPH) Announces Positive Results for Phase 3 Pivotal Trial for Epidiolex, Shares Soar
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 Epidiolex, which is presently in Phase 3 clinical development, is designed to treat Lou Gehrig’s disease and Tuberous Sclerosis Complex in addition to childhood epilepsy.

This morning, GW Pharmaceuticals announced it had reached positive results of the second randomized, double blind, placebo controlled Phase 3 clinical trial for Epidiolex or cannabidiol also known as CBD. Epidiolex showed positive results for the treatment of seizures associated with Lennox-Gastaut syndrome or LGS, a rare form of severe childhood onset epilepsy.

Orrin Devinsky, M.D., of New York University Langone Medical Center's Comprehensive Epilepsy Center and principal investigator in the trial stated in this morning’s press release that, “The positive outcome in this second trial of Epidiolex in patients with Lennox-Gastaut syndrome demonstrates the effectiveness of this product in this particularly difficult to treat, childhood-onset epilepsy. The data from the Epidiolex Dravet and LGS studies offers the prospect of an FDA-approved CBD medicine that shows both clinically meaningful seizure reduction and a consistent safety and tolerability profile. I believe Epidiolex has the potential to become an important new option within the field of treatment-resistant epilepsy.”

The trial showed that when added to a patient’s current treatment, Epidiolex achieved its primary endpoint for both dosage levels with high statistical significance. According to the study, patients taking 20 mg/kg/day achieved a median reduction in monthly drop seizures of 42 percent compared to 17 percent for patients taking a placebo.

Patients taking the 10 mg/kg/day dosage of Epidiolex showed a median reduction of 37 percent of monthly drop seizures versus a 17 percent reduction in patients taking a placebo. The current trial follows a June 2016 trial in which the drug achieved positive results for the treatment of seizures related to LGS or Lou Gehrig’s syndrome, and the March 2016 trial where the drug tested positive for the treatment of seizures related to Dravet syndrome.

The company expects to submit a New Drug Application or NDA for the treatment to the U.S. Food and Drug Administration by the first half of 2017. With this morning’s action, GW Pharmaceutical stock will open at a new yearly high and could test its all time high of $122.82 made in April of 2015.

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Published on Sep 26, 2016
By Jay Hawk
Jay Hawk
Jay Hawk enjoyed a 12-year professional financial markets career incorporating extensive first hand futures and options experience obtained by trading in the stock, commodity and forex markets on U.S. exchanges. Since retiring as a full-time financial market professional, he has been actively trading stock, commodities, forex and options for his own account and managing funds for others, as well as writing financial market commentary and educational articles.

Copyrighted 2020. Content published with author's permission.

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