GW Pharma begins second Phase III trial of Epidiolexto treat lennox-gastaut syndrome

Last year, the company secured orphan drug designation from the US Food and Drug Administration (FDA) for Epidiolex to treat LGS.

The company intends to report top-line data from this Phase III trial in the first quarter of next year.

The LGS Phase III pivotal trial program includes two studies, both of which include a randomized, double-blind, 14-week comparison of Epidiolex versus placebo including a two-week titration period followed by a 12-week maintenance period.

Of the two, one Phase III trial has two arms of 50 patients 20mg/kg and placebo, while the second includes a low dose treatment arm and therefore includes a total of 150 patients.

GW chief executive officer Justin Gover said: "With the commencement of this trial, GW’s pivotal program of four Phase III trials for Epidiolex in Dravet syndrome and Lennox-Gastaut syndrome is now fully underway.

"The long-term prognosis for Lennox-Gastaut syndrome patients is poor in terms of seizure control and cognitive development and patients typically have continued seizure activity into adulthood.

"GW is committed to bringing Epidiolex to patients as a new option to address this significant unmet need."

In both the trials, the primary measure of efficacy will be the comparison between Epidiolex and placebo in the percentage change from baseline in number of drop seizures.

Furthermore, several additional efficacy and safety secondary outcome measures will be analysed in these trials.

After participation in these trials, all patients are eligible to receive Epidiolex under a long term open label extension study.

Apart from Epidiolex clinical programs in LGS and Dravet syndrome, the company has also announced plans to develop Epidiolex for the treatment of Tuberous Sclerosis Complex, a rare pediatric genetic disorder.

The company intends to begin a TSC Phase III clinical program in the second half of this year.