TEL AVIV, Israel, April 9, 2018 Therapix Biosciences Ltd. (NASDAQ: TRPX) ("Therapix" or "the Company"), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics from its proprietary cannabinoid product platform THX-110, announced today topline results from its investigator-initiated Phase IIa study at Yale University, suggesting that THX-110 [which is a combination of dronabinol (∆-9-tetrahydracannabinol) and palmitoylethanolamide (PEA)] significantly improved symptoms over time in adult Subjects with Tourette syndrome.
"The successful completion of this study is a key milestone in our clinical development plan of our proprietary drug candidate THX-110 for the treatment of Tourette syndrome for which current available treatments are frequently inadequate or unsafe," said Adi Zuloff-Shani, Ph.D, Chief Technology Officer at Therapix. "Moreover, these results are of particular interest as the pharmacology of THX-110 appears to be distinct from existing medications for TS and may offer a unique option for treating these patients. This study was designed primarily to confirm safety, tolerability and feasibility in this challenging patient population and is encouraging that we obtained positive data that suggests that the combination of dronabinol (∆-9-tetrahydracannabinol) and palmitoylethanolamide (PEA) (THX-110) should be pursued as a treatment for TS patients," continued Dr. Zuloff-Shani. "Based on these study results, we intend to initiate a randomized, double-blind, placebo controlled study to evaluate the safety, tolerability and efficacy of daily oral THX-110 in treating adults with Tourette syndrome."
The study was a single-arm, open-label trial, in which each subject both received one daily treatment of the drug via oral administration and was followed-up for a period of 12 weeks. Sixteen subjects participated in the study and received THX-110 at the Yale University Child Study Center at Yale University, USA. The primary endpoint of the study was to assess the performance of THX-110 in the treatment of adult patients suffering from symptoms of Tourette syndrome, as measured by the Yale Global Tic Severity Scale Total Tic Score (YGTSS-TTS), the gold-standard and customary index for assessing symptom severity. Treatment was given in a dose titration regimen with a maximum dose of THX-110 consisting of 10mg Dronabinol and 800mg PEA.
The study was investigator-initiated 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., of the Neison Harris Professor in the Child Study Center and Professor of Pediatrics Child Psychiatry at Yale University.
The study showed that these 16 subjects with medication-refractory TS had a reduction of tic symptoms (paired t-test: YGTSS-TTS mean difference (mean +/- SD) =7.9+/-8.4, t= 3.7, df=15, p=0.002) from baseline (YGTSS-TTS: 38.4 +/- 8.3) to endpoint (YGTSS-TTS: 30.5 +/- 10.9). This resulted in an average tic reduction of 21% across the entire sample.
Six of the 16 medication-refractory TS subjects experienced a response to treatment as defined by a reduction in YGTSS-TTS of greater than 25%. Improvement over time with treatment was also observed when generalized linear models were used to analyze repeated measures data on the YGTSS-TTS. THX-110 demonstrated no significant effects on comorbidity. The medication was generally well-tolerated by subjects with only two subjects stopping treatment early (one due to sedation and another due to lack of improvement in tic symptoms). Twelve of the 16 subjects elected to continue into a 24-week extension phase of the trial, which is nearing completion.
"In general, this study enrolled 16 adults, most of which had severe, refractory Tourette syndrome that had not responded to previous evidence-based treatment (e.g. antipsychotic medications, alpha-2 agonists, behavioral therapy) and multiple investigational compounds (e.g. topiramate, VMAT-inhibitors, repetitive transcranial magnetic stimulation, deep brain stimulation). A subset of these subjects experienced improvement in tic symptoms during the course of the study. The overall improvement of tics in this sample of severe, adult TS is quite encouraging and further placebo-controlled trials are needed in an attempt to demonstrate efficacy," said Dr. Michael Bloch, M.D., principal investigator of the study.
"We believe that the efficacy demonstrated in this study further reinforce the potential role of cannabinoids in the field of CNS and movement disorders and suggests that Therapix Biosciences may have a proprietary cannabinoid product candidate in the treatment of Tourette syndrome," stated Dr. Ascher Shmulewitz, M.D., Ph.D, Chairman and interim CEO of Therapix said. "These data are a catalyst for the acceleration of Therapix's Entourage Effect research interests."
Complete results from this study will be presented at the 2018 European Society for the Study of Tourette syndrome meeting in Copenhagen, Denmark.
About Therapix Biosciences
Therapix Biosciences Ltd. is a specialty clinical-stage pharmaceutical company led by an experienced team of Senior Executives and Scientists. Our focus is creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. With this focus, the company is currently engaged in the following drug development programs based on repurposing an FDA-approved synthetic cannabinoid (Dronabinol): THX-110 for the treatment of Tourette syndrome (TS), for the treatment of Obstructive Sleep Apnea (OSA), and for the treatment of Pain; THX-130 for the treatment of Mild Cognitive Impairment (MCI) and Traumatic Brain Injury (TBI); and THX-150 for the treatment of infectious diseases. Please visit our website for more information at www.therapixbio.com
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Because such statements deal with future events and are based on Therapix's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Therapix could differ materially from those described in or implied by the statements in this press release. For example, forward-looking statements include statements regarding the Company's plans with respect to its clinical trials and its intent to report material developments and information regarding such trials. In addition, historic results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in Therapix Biosciences Ltd.'s Annual Report on Form 20-F filed with the Securities and Exchange Commission (SEC) on May 1, 2017 and in subsequent filings with the SEC. Except as otherwise required by law, Therapix disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.
SOURCE Therapix Biosciences Ltd.