7th May 2014 13:29
LONDON (Alliance News) - GW Pharmaceuticals PLC Wednesday said it expects to start a phase II/III clinical trial for developmental childhood Epilepsy drug Epidiolex in the second half of 2014, after the US Food and Drug Administration confirmed that its investigational new drug application is now open.
Epidiolex has already received orphan drug designation from the FDA for the treatment of Dravet syndrome, a rare and catastrophic treatment-resistant form of childhood epilepsy, and opening of the the investigational new drug application is a key step in the process of getting a drug approved.
"This journey began with requests from the US epilepsy physician and patient community to utilize Epidiolex and has now led to GW embarking on its own formal development program with a view to seeking market authorization from the FDA as rapidly as possible. We are committed to providing a prescription cannabidiol medicine for children with Dravet syndrome who have exhausted all other therapeutic options," GW Pharma Chief Executive Justin Glover said in a statement.
GW Pharma is a specialist biopharma company that developed cannabinoid treatment Sativex to help patients with multiple sclerosis deal with the resulting spasticity and cancer patients deal with pain, and Epidiolex for the treatment of childhood epilepsy. It also has several cannabinoid developmental drugs in phase II trials, including a potential ulcerative colitis treatment, a type-2 diabetes treatment, and a schizophrenia treatment.
The company said the phase II/III trial will test the safety, tolerability, and efficacy of single and multiple doses of Epidiolex to treat Dravet syndrome in children who are being treated with other anti-epileptic drugs. Part one comprises the pharmacokinetic and dose-finding elements of the trial in a total of 30 patients over a three week treatment period. Part two is a placebo-controlled safety and efficacy evaluation of Epidiolex over a three month treatment period in a total of 80 patients.
It said it expects to start an additional phase III trial in Dravet syndrome in the first quarter of 2015 in parallel with part two of the first Phase II/III trial.
Epidiolex has also been given orphan drug designation by the FDA for Lennox-Gastaut syndrome, another childhood epilepsy condition. GW Pharma said it expects to hold a pre-investigational new drug application meeting with the FDA for Epidiolex in the treatment of this syndrome in mid-2014, and aims to conduct two Phase III trials in the syndrome during 2015.
Separately, the company said it swung to a net loss in the first half of its current financial year as higher research and development costs more than offset a rise in revenue.
The company reported a GBP8.0 million loss for the six months to March 31, compared with a profit of GBP124,000 a year earlier, as revenue rose to GBP15.0 million, from GBP12.9 million, but R&D costs rose to GBP21.0 million, from GBP15.1 million.
Its fiscal second quarter loss widened to GBP5.2 million, from GBP1.9 million, as revenue fell to GBP7.5 million, from GBP7.7 million, and R&D costs rose to GBP11.9 million, from GBP8.7 million.
GW Pharma shares were down 3.2% at 354.75 pence Wednesday.
By Steve McGrath; [email protected]; @stevemcgrath1
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