Our company was co-founded in 1998 by Dr. Geoffrey Guy and Dr. Brian Whittle, two well-known entrepreneurs in the UK biotech sector. Drs. Guy and Whittle worked closely with both the UK Home Office and the UK’s medicines regulatory authority on establishing necessary licences and procedures so as to facilitate our cannabinoid research program.
Greenwich Biosciences, Inc.'s lead product candidate is Epidiolex® (cannabidiol or CBD), a liquid formulation of pure cannabidiol (CBD) for severe childhood-onset, drug-resistant epilepsy syndromes. Epidiolex (CBD) is the result of extensive pre-clinical research of CBD which dates back to 2007. This research has demonstrated significant anti-epileptiform and anticonvulsant activity using a variety of in vitro and in vivo models. In 2013, the US organization was established to commence a clinical program in childhood-onset epilepsies with initial focus on two rare and particularly difficult to treat forms of epilepsy: Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS), both of which have been granted orphan drug designation by the FDA. In addition, we have been granted Fast Track designation for Dravet syndrome by the FDA. We have since commenced Phase 3 development of Epidiolex (CBD) in a third orphan indication, Tuberous Sclerosis Complex (TSC) and expect to commence a Phase 3 trial in Infantile Spasms (IS).
In 2016, the first Phase 3 results were reported. Our company's focus is to bring novel, cannabinoid-based prescription medicines to patients in areas of serious unmet need and in which our medicines can make a real difference.
Our strategy is to maintain a world leading position in the field of cannabinoid science, and in the research, development and commercialization of cannabinoid molecules as novel prescription therapeutic candidates. In seeking to implement this strategy, we have developed an extensive international network of the most prominent scientists in the cannabinoid field. We have also assembled a large in-house team with extensive experience in multiple facets of cannabinoid pharmaceutical product development. We manufacture our prescription pharmaceutical products to meet the stringent cGMP requirements of the FDA and other global regulatory authorities and retain control over all facets of product development, manufacturing and commercial distribution.
Epidiolex (CBD) is an investigational drug not approved for any indication.