GW Pharma surges on new epilepsy trial success
UK-based GW Pharmaceuticals surged ahead on the stock market after it announced its cannabis-based drug Epidiolex had succeeded in a phase 3 trial that could lead to a new use.
The company’s Q1 results, announced at the same time, show that Epidiolex (cannabidiol) is gaining traction in the US market, where it has been approved for the rare forms of childhood epilepsy Lennox-Gastaut syndrome and Dravet Syndrome since last summer.
GW is also hoping for approval in tuberous sclerosis complex, and analysts have suggested that with these three indications in the bag the drug could go on to break the billion dollar annual sales barrier at peak.
GW said it plans to file for a new use for Epidiolex in the final quarter, to treat patients with tuberous sclerosis complex, another form of rare childhood epilepsy.
Results from the trial showed that both groups saw significant reductions in seizure frequency compared with placebo, meeting the trial’s primary endpoint.
Results for both the 25 and 50 mg/kg/day dose groups were similar, with seizure reductions of 48.6% and 47.5% from baseline respectively, versus 26.5% for placebo.
The company said there were no surprises in terms of safety, with most common adverse events including somnolence, decreased appetite and diarrhoea.
The company said that there were fewer incidences of adverse events in the lower dose of 25mg/kg/day, and that label expansion discussions with the FDA will focus on the lower dose.
This is close to the dose range already included in US prescribing information, said GW’s chief medical officer Volker Knappertz.
Tuberous sclerosis complex (TSC) is a rare genetic condition that causes tumours to grow in many different organs of the body.
It affects up to 80,000 children in the US and 1-2 million people worldwide.
In its results GQ said Q1 revenues were $39.2 million after Epidiolex’s approval in June last year.
The company is still losing money however, with the results showing that its losses widened by almost 28% to $50.1 million.
Epidiolex is a cannabis-derived medicine designed to give therapeutic benefits without the ‘highs’ associated with ingesting the plant in its raw form.
Shares were up almost 3% on the Nasdaq following the news.
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