GW Pharmaceuticals, a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced on February 21 that a Phase 2a proof-of-concept study of a pipeline compound GWP42006 in adult patients with focal seizures did not meet its primary endpoint. GWP42006 is also being developed within the field of autism spectrum disorders (ASD) which will represent an increased therapeutic focus for ongoing development of this pipeline compound.
The Phase 2a placebo-controlled study evaluated the efficacy and safety of GWP42006, which features cannabidivarin (CBDV) as the primary cannabinoid molecule, as add-on therapy in 162 adult patients with inadequately controlled focal seizures. The trial was conducted outside the United States, primarily in Eastern Europe. In the trial’s preliminary top-line results, both active and placebo arms showed similar reductions in focal seizures of approximately 40 percent. The extent of this placebo response is substantially greater than that seen in published studies of other treatments in similar patient populations and the Company is now working to understand the potential reasons for this result. In the trial, GWP42006 was generally well tolerated. More patients in the active group (73 percent) experienced treatment emergent adverse events compared to the placebo group (48 percent). A majority of the GWP42006 patients experienced adverse events of mild or moderate severity. The incidence of serious adverse events was low (3.7 percent on active compared to 1.2 percent on placebo).
GWP42006 has shown anti-epileptic properties across a range of in vitro and in vivo models of epilepsy. GW will continue to explore potential development opportunities for this compound in the field of epilepsy.