TEL AVIV, Israel, Dec. 4, 2017 /PRNewswire/ — Therapix Biosciences Ltd. (Nasdaq: TRPX), a specialty clinical-stage pharmaceutical company specializing in the development of cannabinoid-based therapies, announces the completion of enrollment in its investigator-initiated Phase IIa study at Yale University evaluating its investigational compound THX-110, a therapeutic compound consisting of FDA-approved dronabinol (synthetic ∆-9-tetrahydracannabinol) and palmitoylethanolamide (PEA) , for Tourette syndrome. Sixteen patients have been enrolled in the study. Top-line results are currently anticipated in the first half of 2018.
“The completion of enrollment for this study is a significant milestone for Therapix,” said Dr. Adi Zuloff-Shani, Chief Technology Officer at Therapix. “We’re optimistic that this study will support earlier clinical research documenting the therapeutic benefits of cannabinoid-based therapies and may suggest that the combination of dronabinol and PEA, which we are developing as our investigatory compound THX-110, will demonstrate a safe and efficacious treatment for this highly debilitating disease with high unmet medical need. In addition, enrollment was completed on time and on budget.”
The study is sponsored by Therapix and led by Michael H. Bloch, M.D., Associate Professor at the Yale University Child Study Center, and James F. Leckman, M.D., Ph.D., Neison Harris Professor in the Child Study Center and Professor of Child Psychiatry at Yale University.
Dr. Bloch added, “As there are many adult patients with Tourette syndrome who do not respond to antipsychotic medications and other treatments currently approved to treat tic symptoms, we are hopeful that a new treatment with a novel mechanism of action will be safe, well-tolerated and efficacious and that it can advance to a large, double-blind, placebo-controlled study.”
The Yale study is a single-arm, open-label study, in which subjects receive once-daily oral treatment of the investigational drug for 12 weeks. The objective of the clinical study is to prove the safety, tolerability and efficacy of the combination of dronabinol and PEA in adult patients with Tourette syndrome. The primary efficacy endpoint is the change from baseline to the end of the 12-week treatment in the Yale Global Tic Severity Scale Total Tic Score (YGTSS-TTS), which is a clinical measure designed to provide an evaluation of tic severity. Secondary efficacy endpoints include demonstrating the safety and tolerability of the dronabinol and PEA combination and to evaluate its benefit on premonitory urges, quality of life, disease severity and comorbidities including ADHD, OCD, depression and anxiety. More information about the study is available on clinicaltrials.gov.
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Therapix Biosciences Ltd.