TEL AVIV, Israel, May 8, 2017 /PRNewswire/ -- Therapix Biosciences Ltd. (Nasdaq: TRPX) ("Therapix"), a specialty clinical stage pharmaceutical company specializing in the development of cannabinoid-based drugs, today announced that it entered into a trial agreement with the Hannover Medical School to conduct a proof-of-concept Phase II clinical study with its lead compound, THX-TS01, for patients suffering from Tourette Syndrome.
Therapix Biosciences
As previously reported, this investigator initiated study, is projected to be initiated during the third quarter of 2017, subject to receiving necessary regulatory approvals in Germany. The study will be conducted at Hannover Medical School in Germany under the leadership of principal investigator, Professor Kirsten Muller-Vahl. The study will be a randomized, double-blind, placebo controlled cross-over proof-of-concept Phase II clinical study to evaluate the safety, tolerability and efficacy of up to twice daily oral THX-TS01 in treating adults with Tourette Syndrome (the "Hannover Study"). Each subject will be randomized to receive either THX-TS01 or placebo in a 1:1 ratio via oral administration. A total of 20 patients will be evaluated in a cross-over design. In the first stage, the patients will be randomized to either treatment or placebo and will be treated for a duration of 13 weeks. Afterwards, the patients will be crossed-over and will be treated for an additional 13 weeks; patients who initially received placebo will receive treatment and vice versa. The primary endpoint of the Hannover Study is to evaluate the safety, tolerance and efficacy of THX-TS01. The primary efficacy endpoint will be measured according to Yale Global Tic Severity Scale Total Tic Score, a widely-accepted index for assessing symptom severity and frequency. In addition, the effect of THX-TS01 will be evaluated by several secondary endpoints, including additional scales for measuring tics severity as well as other mental disorders that often accompany Tourette Syndrome, including OCD and ADHD.
"The therapeutic effect of THC in several CNS-related indications has long been established and my lab at Hannover Medical Schools feels fortunate to have been centrally involved in that research," stated Professor Kirsten Muller-Vahl, department of Psychiatry, Socialpsychiatry and Psychotherapy and head of the Tourette outpatient clinic at Hannover Medical School. Professor Muller-Vahl continued, "This robust study that we are embarking upon with Therapix Biosciences will assess the potential synergistic effect of THC in combination with PEA, in what my esteemed colleague Professor Raphael Mechoulam coined the 'Entourage Effect' many years ago. We're enthusiastic to be conducting this study, and optimistic about its findings," concluded Professor Muller-Vahl.
Dr. Elran Haber, Therapix's Chief Executive Officer, stated "We're excited to embark upon the Hannover Study. Hannover Medical School is well regarded as a center of excellence in this area of research, and Professor Muller-Vahl is a recognized key opinion leader in both cannabinoid-based therapeutics and Tourette Syndrome." Dr. Haber concluded, "We're optimistic that the Hannover Study, in conjunction with our currently ongoing study at Yale University, will support earlier research done with cannabinoid-based therapies and may suggest that THX-TS01 is a safe and efficacious treatment for this highly debilitating disease with high unmet medical need."
