GW Pharmaceuticals ($GWPH), at work on treatments derived from cannabis, is planning to expand its focus to schizophrenia after charting some positive signs in an exploratory trial.
The company compared cannabidiol, the active ingredient in its lead drug, with placebo in 88 patients with schizophrenia who didn't respond to first-line therapy. GW Pharma's treatment demonstrated a statistically significant improvement on three measures of schizophrenia severity, the company said, adding that "the majority of other endpoints in the study were in favor of (cannabidiol) and approached statistical significance in many cases."
On the safety side, cannabidiol's most common side effects were diarrhea, nausea and headache, but the overall frequency of adverse events was similar to placebo, GW Pharma said.
The exploratory study is designed to generate hypotheses and doesn't pave a path to the FDA, but GW Pharma believes it has seen enough to consider pursuing further studies in schizophrenia. And investors would seem to agree, sending the company's shares up about 10% on Tuesday morning.
GW Pharma has seen its market value soar over the last year on the promise of its pipeline of drugs crafted from cannabidiol, a part of the marijuana plant that doesn't induce a high. Epidiolex, the company's top prospect, is in the midst of Phase III trials to determine how well it can reduce seizure rates for children with Dravet and Lennox-Gastaut syndromes, two rare epileptic disorders.
The company has been consistently running small, open-label studies to spotlight potential new applications for its pipeline, talking up plans to launch new studies based on the positive results. And cannabidiol's potential effect on schizophrenia is no different, with GW Pharma CEO Justin Gover pointing out a possible path forward in rare forms of the disorder.
"We believe that the signals of efficacy demonstrated in this trial, together with a notably reassuring safety profile, provide GW with the prospect of new and distinct cannabinoid neuropsychiatric product pipeline opportunity," Gover said in a statement. "Similar to our approach for Epidiolex, we believe that our future research in this area may lie within pediatric orphan neuropsychiatric indications and we intend to explore this as a focus for future trials."
- read the statement