GW Pharmaceuticals starts GWP42006 Phase 1 clinical trial for epilepsy treatment

Sep 18 2013

GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: GWP, "GW") announced today it has commenced a Phase 1 clinical trial of product candidate GWP42006 for the treatment of epilepsy.

Over the last five years, GW has conducted an extensive pre-clinical cannabinoid research program in the field of epilepsy in collaboration with the University of Reading in the United Kingdom. This research has led to the emergence of a number of promising cannabinoid therapeutic candidates showing anti-epileptic effects. GWP42006, one of the most promising of those candidates, is a non-psychoactive cannabinoid extracted from specific chemotypes of the cannabis plant which has shown the ability to treat seizures in pre-clinical models of epilepsy with significantly fewer side effects than currently approved anti-epileptic drugs.

"We are pleased to have advanced GWP42006 to first dose in man, a significant milestone in the development of this novel product candidate. The decision to progress into Phase 1 follows several years of highly promising pre-clinical research," stated Dr. Stephen Wright, Director of Research and Development at GW. "We believe that GWP42006 has the potential to become an important advance in the treatment of epilepsy, a condition for which there remains a substantial unmet medical need."

Dr. Ben Whalley, Senior Lecturer in Pharmacology at the Reading School of Pharmacy, said, "Our research collaboration with GW over the last several years has shown that GWP42006 not only exerts significant anticonvulsant effects in a wide range of preclinical models of seizure and epilepsy but is also better tolerated compared to existing anti-epileptic drugs. It is also noteworthy that GWP42006 appears to employ a different mechanism of action to currently available anti-epileptic treatments. Together, these findings fully support the exciting clinical development that is now underway and represent an important step towards a more effective and better tolerated treatment for epilepsy."

Separately, GW's activities in the field of epilepsy have expanded in recent months as a result of emerging interest among U.S. pediatric epilepsy specialists and patient organizations in the potential role of a distinct cannabinoid product candidate, Cannabidiol (CBD), in treating intractable childhood epilepsy. Three expanded access INDs have recently been granted by the FDA to U.S. clinicians to allow treatment of a small number of pediatric epilepsy patients with a CBD formulation supplied by GW. These activities may generate initial evidence to add CBD as a further pipeline candidate for clinical evaluation in epilepsy.

Epilepsy is a complex neurological disorder characterized by spontaneous recurrence surges of electrical activity in the brain resulting in unprovoked seizures. Epilepsy is estimated to affect 50 million people worldwide including, according to the Centers for Disease Control and Prevention, 2.2 million people in the United States. Drug therapy remains ineffective for seizure control in up to 30% of patients with epilepsy because either the drugs do not control the seizures or the patients cannot tolerate the side effects. Currently available drugs can cause significant side effects particularly affecting movement and cognition that can adversely affect the quality of life for epileptic patients.