Data from two Phase III trials (with 171 and 225 patients, respectively) of Epidiolex in Lennox-Gastaut (LGS) patients are coming soon with the first trial to report out in June with the second coming in Q316. In the latest expanded access programme data, Epidiolex reduced atonic/drop seizure frequency by a median of 71.1%. Previous data suggest a placebo response rate in LGS of around 10% which, combined with the size of the trials, indicates sufficient power to demonstrate a difference.
Positive Dravet results increase confidence in LGS
In March, GW Pharmaceuticals Plc (NASDAQ:GWPH) announced clinically and statistically significant results from its 120-patient Phase III trial of Epidiolex (cannabidiol or CBD) in Dravet syndrome, another severe form of paediatric epilepsy like LGS. The treatment arm showed a 39% reduction in convulsive seizures per month compared to 13% for placebo (p=0.01). On average, patients were taking three anti-epileptic treatment regimens concomitantly (though were still seeing a median convulsive seizure frequency of 13 per month) and had previously tried and failed four other treatments.
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