Date: 2015-05-06
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: GW Pharmaceuticals (UK)
Product: GWP42006 (cannabidivarin)
Action
mechanism: cannabinol derivative/endocannabinoid modulator. GWP42006 is the non-psychoactive cannabinoid cannabidivarin (CBDV) extracted from the cannabis plant.
Disease: epilepsy
Therapeutic area: CNS diseases - Neurological diseases
Country: UK
Trial
details: This study is a two-part, Phase 2, double blind, randomized, placebo controlled study. Part A is designed to investigate the pharmacokinetics, safety and tolerability of GWP42006 compared with placebo in 30 patients, as add-on therapy in patients with inadequately controlled focal seizures (NCT02369471). Part B will evaluate the efficacy of GWP42006 compared with placebo in 100 patients, as add-on therapy to treat inadequately controlled focal seizures (NCT02365610)
Latest
news: * On May 6, 2015, GW Pharmaceuticals announced that it has commenced a Phase 2 clinical trial of GWP42006 in adult patients with epilepsy. This study is a two-part, Phase 2, double blind, randomized, placebo controlled study. Part A is designed to investigate the pharmacokinetics, safety and tolerability of GWP42006 compared with placebo in 30 patients, as add-on therapy in patients with inadequately controlled focal seizures. Part B will evaluate the efficacy of GWP42006 compared with placebo in 100 patients, as add-on therapy to treat inadequately controlled focal seizures. This study follows completion of a Phase 1 trial in 66 healthy subjects in 2014. In this trial, CBDV was well tolerated even at the highest tested dose and no significant side effects were observed. There were no serious or severe adverse events, nor any withdrawals due to adverse events.
GW’s patent portfolio related to CBDV includes a granted patent in Great Britain for the use of CBDV in the treatment of epilepsy and a Notice of Allowance for the corresponding application with the U.S. Patent and Trademark Office (USPTO) covering CBDV alone or in combination with standard anti-epileptic drugs. The issued patent from this application will provide an exclusivity period until 30 March 2031. In total, GW has four patent families with claims related to the use of CBDV in the treatment of epilepsy and CBDV in combination with CBD in the treatment of epilepsy, as well as compositions, extraction techniques, and CBDV extracts.
