GW Pharma shares jump on Phase 3 data for cannabis-based drug
- A cannabis-derived drug from GW Pharmaceuticals proved effective in reducing the frequency of seizures among children and teens with a rare form of epilepsy, the London-based company said Monday.
- Data from the first of two Phase 3 trials testing the drug, Epidiolex, against Lennox-Gastaut syndrome (LGS) showed treatment led to a statistically significant reduction in the number of seizures, compared to a baseline.
- The news buoyed shares of GW Pharma upwards by nearly 12% on the London Stock Exchange, and morning trading led to a similar spike on U.S. markets, although those gains were pared back somewhat by Monday's close.
Monday's data follows previous positive results from a separate Phase 3 trial testing Epidiolex against another form of epilepsy known as Dravet syndrome. GW Pharma is developing the drug, which is derived from an oil found in the cannabis plant, for two other seizure disorders in addition to LGS and Dravet.
In the most recent Phase 3 trial, GW Pharma tested Epidiolex in 171 children with LGS, split equally between those receiving treatment and those receiving a placebo. Before treatment, participants averaged 74 drop seizures, or a seizure which led to a fall, per month.
Patients who received Epidiolex experienced a 44% median reduction in the number of drop seizures per month, while those on the placebo saw only a 22% drop. The difference between groups was statistically significant.
Although the drug was deemed to be well tolerated, side effects were broadly experienced. Nearly nine out of ten patients in the treatment arm experienced an adverse event, compared to 69% of patients receiving a placebo. Severe adverse events, including one death, were reported in twenty patients. The death, however, was judged to be unrelated to treatment, according to the company.
GW Pharma has already completed enrollment for a second Phase 3 trial testing Epidiolex against LGS, which should support a filing with the Food and Drug Administration sometime in the first half of 2017, provided the data is positive.
LGS usually surfaces in early childhood and has a number of known causes, although there is no evident precipitating factor in as many as 30% of patients. The company estimates LGS affects between 14,000 and 18,500 patients in the U.S., along with 23,000-31,000 patients in Europe.
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