GW Pharmaceuticals plc, a biopharmaceutical company, has started a phase 2 clinical trial of GWP42006 in adult patients with epilepsy. GWP42006 is the non-psychoactive cannabinoid cannabidivarin (CBDV) extracted from the cannabis plant.
“The start of this phase 2 CBDV study represents another important milestone for GW’s research in the field of epilepsy,” stated Justin Gover, GW’s chief executive officer.
“While much of the recent attention regarding GW has been associated with our Epidiolex childhood epilepsy programme which has now advanced into phase 3 trials,we believe that CBDV represents an additional product pipeline opportunity as a next-generation epilepsy therapy. GW has completed significant pre-clinical work on CBDV as well as a phase 1 trial which demonstrated a reassuring safety profile, and we look forward to progressing this phase 2 trial during 2015.”
This study is a two-part, phase 2, double blind, randomised, 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 US 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 March 30, 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.