Shares of GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) tumbled nearly 5% in after-hours trading Wednesday, after the drug maker announced negative results with GWP42006 in adult patients with focal seizures.
GWP42006 trial in focal seizures
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 vivomodels of epilepsy. GW will continue to explore potential development opportunities for this compound in the field of epilepsy.
GWP42006 progress in Autism Spectrum Disorders
In parallel with this study, GW has been evaluating GWP42006 in both general and syndromic pre-clinical models of ASD yielding promising signals on cognitive and social endpoints as well as repetitive behavior. These include both genetically determined abnormalities of neurobehavioral, and chemically-induced models, and include Rett syndrome and Fragile X among others. GW will continue to advance various clinical initiatives within the field of ASD, including a physician-led expanded access IND in 10 patients with autism as well as both open-label and Phase 2 placebo-controlled trials in Rett syndrome, a condition for which GWP42006 has received Orphan Drug Designation from the FDA. Open label data from the expanded access IND are expected later in 2018.
“GW’s R&D focus has evolved in the last few years towards pediatric neurology where we have generated significant positive clinical data. Whilst the results of this adult focal seizure study for GWP42006 are disappointing, we remain committed to advancing this pipeline compound to address unmet needs in the field of autism spectrum disorders, in which a promising body of pre-clinical data has already been generated, as well as continuing to explore the product’s potential within the field of epilepsy,” said Justin Gover, GW’s Chief Executive Officer. “The company’s top priority in 2018 remains Epidiolex, for which we have generated compelling positive data in three Phase 3 trials, and which is currently under regulatory review in the U.S. and Europe. We are very excited at the prospect of launching this potential breakthrough treatment later this year in the U.S., whilst continuing to progress our broad and innovative cannabinoid pipeline.”
GWPH has one of the best ratings by the Street. TipRanks reveals that the drug maker has a Strong Buy analyst consensus rating with 4 back-to-back buy ratings in the last three months. Meanwhile the average analyst price target of $171.33 suggests the stock has an upside potential of just over 29% from today’s closing price.