GW sees R&D investment as core to its strategic vision. We believe that there is a very significant opportunity to leverage our lead position in cannabinoids by entering into new pharmaceutical partnerships to develop a new cannabinoid medicines across a range of disease areas.
Cannabinoid pharmacology provides a rationale for the potential therapeutic use of cannabinoids across a wide range of therapeutic areas. The company has developed a proprietary and validated cannabinoid technology platform and formed constructive collaborations with leading international scientists, universities and institutions in the field.
GW’s extensive research continues to yield highly promising data and new intellectual property and provides GW with the potential to develop and license several new cannabinoid drug candidates in the coming years. The strategy aims to identify pharmaceutical companies with whom to partner in the development and commercialisation of new drugs, with a focus on the following areas:
Several GW cannabinoids have shown anti-inflammatory properties in a number of models of inflammation (Bolognini et al. 2010; Maione et al. 2011, Costa et al. 2007), and have the capacity to inhibit the production in tissues of chemical mediators of inflammation.
GW commenced a Phase IIa study in the inflammatory diseases area in early 2012. This study isinvestigating the efficacy and safety of GWP42003 in the treatment of ulcerative colitis and will include 62 patients. The chief investigator is Dr. Peter Irving at Guy’s and St Thomas’s Hospital, London. Cannabinoids have shown potential in the treatment of Inflammatory Bowel Disease in standard in vivo models (Borrelli et al. 2009, Jamontt et al. 2010).
Separately, GW has entered a formal research collaboration with Professor Clive Page at King’s College London focused on the effect of cannabinoids on various models of airways inflammation and Professor Tamas Biro at the University of Debrecen, Hungary, to investigate the actions of cannabinoids in acne.
GW has initiated a clinical study programme comprising three Phase IIa studies. Thes studies build on highly promising pre-clinical data demonstrating desirable effects of a number of GW cannabinoids on various features of the metabolic disease, notably plasma insulin, cholesterol and liver fat. The three Phase IIa studies are as follows:
- A multi-centre, randomised, double blind, placebo controlled, parallel group pilot study examining the effects on plasma lipid status of GWP42003 and GWP42004 at varying doses and at different ratios in patients with insulin resistance. This study is now fully recruited with a total of 62 patients.
- A randomised controlled study, exploring the effect of GWP42003 on liver fat in 24 patients with non-alcoholic fatty liver disease. This study is fully recruited.
- A 60 patient randomised controlled Phase IIa study investigating whether GWP42003 and GWP42004 can prevent weight gain in patients taking anti-psychotic therapy.
As part of GW’s research effort in this therapeutic area, GW is also working to set up clinical trials in the Gulf, a region with a high prevalence of diabetes.
Neurodegenerative diseases are known to be associated with abnormalities of the endocannabinoid system (Fernandez-Ruiz 2009; Blázquez et al. 2011; Bisogno & Di Marzo 2011). Studies in Huntington’s Disease have shown that both the CB1 and CB2 receptors have a role in disease progression, and cannabinoids are neuroprotective in animal models of Huntington’s Disease. A small preliminary clinical study programme looking at the impact of treatment with cannabinoids in Huntington’s Disease in collaboration with the Spanish network for the study of neurodegenerative diseases has just completed. In addition, cannabinoids have been shown to have symptom-relieving and neuroprotective activity in models of Parkinson’s Disease (Garcia et al. 2011) and Alzheimer’s Disease.