September 15, 2015
By Mark Terry, BioSpace.com Breaking News Staff
London, UK-based GW Pharmaceuticals plc announced today that its proprietary cannabinoid product, Cannabidiol (CBD), showed positive top line results in a Phase IIa clinical trial in patients with schizophrenia.
GW Pharmaceuticals focuses on the discovery and development of therapeutic drugs based on its proprietary cannabinoid product platform, in other words, the chemical components of marijuana. The study looked at 88 patients with schizophrenia who did not respond well to first line anti-psychotic medications. Patients received either CBD or a placebo as adjunct therapy.
CBD showed consistently better results over placebo. The company stated, “CBD was consistently superior to placebo, with the most notable differences being in the PANSS positive sub-scale (p=0.018), the Clinical Global Impression of Severity (p=0.04) and Clinical Global Impression of Improvement (p=0.02).” The company noted that the safety profile of the drug was “particularly reassuring, with no serious adverse events and an overall frequency of adverse events very similar to placebo.”
“The addition of Cannabidiol to the medication of patients who were only partially responsive to standard anti-psychotic treatment produced significant improvement in outcome measures compared with placebo,” said Philip McGuire, head of the Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience at King’s College London and principal investigator of the study in a statement. “Moreover, these improvements were not associated with adverse effects. The results are of particular interest because the pharmacology of CBD is distinct from existing anti-psychotic medications, all of which act via effects on dopamine receptors.”
GW Pharmaceuticals took a jump at the news. Shares traded on Oct. 15, 2014 for $114.78 and rose to $121 on April 24, 2015, and then to $129.69 on June 25, 2014. Prices dropped to $106.90 on Sept. 14, but is currently trading at $114.69.
Seven analysts gave the company an average recommendation of “buy,” according to Analyst Ratings Net. Two analysts gave it a “hold” rating and five gave it a “buy” rating. The average 12-month target price was $139.59.
The company’s drug was originally used to treat epilepsy (Sativex), but is showing positive results in schizophrenia treatment. On Aug. 6, 2015, the company FDA Fast Track and EMA Orphan Designations for Intravenous Cannabidiol in the Treatment of Neonatal Hypoxic-Ischemic Encephalopathy NHIE.aspx” target="_blank">received Fast Track designation from the U.S. Food and Drug Administration (FDA) for an intravenous form of CBD to treat Neonatal Hypoxic-Ischemic Encephalopathy (NHIE). The European Medicines Agency (EMA) also granted the drug orphan designation to treat perinatal asphyxia, which is the same condition as NHIE with a different name. There are no medications approved for either disorder in Europe or the U.S.
“GW believes that cannabinoids may have a potentially important role in the treatment of high need pediatric neurologic conditions,” said Justin Glover, the company’s chief executive officer in a statement. “As a result, we have developed a proprietary intravenous CBD formulation specifically for use in this most vulnerable of patient populations, newborn infants with NHIE. As there are no current treatment options beyond induced hypothermia for the affected newborns, there exists a dramatic need to develop new and effective therapies aimed at preventing acute brain damage and enhancing long-term brain repair.”
