Nasdaq-listed Therapix Biosciences Ltd., a Tel Aviv-based company developing a cannabinoid-based drug for the treatment of Tourette Syndrome, announced on Monday it had successfully completed a phase IIa clinical trial for its product.
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Established in 2004, clinical-stage Therapix Biosciences develops drugs for the treatment of neurological conditions, pain management, and infectious diseases. Its therapies are based on a cannabis compound called Dronabinol, a synthetic THC that has already been approved by the U.S. Food and Drug Administration for the treatment of conditions such as chemotherapy-induced side-effects.
Tourette, which is usually diagnosed in early childhood, is a neurological disorder that affects 1 in every 360 children, according to the U.S. Centers for Disease Control and Prevention (CDC). It is characterized by repetitive, involuntary movements and noises called tics. In 10%-15% of those affected the symptoms are severe enough to be considered a disability, according to the U.S. National Institute of Neurological Disorders and Stroke, and the most common medical treatment is antipsychotics, which are not completely effective and can have problematic side effects.
Conducted at Yale University, Therapix Biosciences' 12-week trial enrolled 16 adult participants. The average tic reduction across all 16 participants was 21%, the company said, with six experiencing an improvement of over 25%, and 12 participants electing to continue into a 24-week extension phase.
The company now intends to launch a randomized, double-blind, placebo-controlled study for the drug.
"We believe that the efficacy demonstrated in this study further reinforce the potential role of cannabinoids in the field of central nervous system and movement disorders, and suggests that Therapix Biosciences may have a proprietary cannabinoid product candidate in the treatment of Tourette syndrome," Chairman and interim CEO of Therapix Biosciences Ascher Shmulewitz said in a statement.