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New Study Finds that Cannabis Helps Tourette Syndrome Symptoms

Therapix Biosciences announced results of their Cannabis Specific Study at Yale University for Tourette syndrome program

NEW HAVEN, CT – 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 in New Haven, Conn. 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. 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.

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.

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

About Dr. Michael Block, MD, MS

Dr. Michael H. Bloch graduated from Yale School of Medicine and completed his child and adult psychiatry training at Yale. He is currently serving as Chief Resident at the Clinical Neuroscience Research Unit in the Yale Department of Psychiatry. His research interests focus on studying Tourette syndrome (TS), obsessive-compulsive disorder (OCD) and trichotillomania (TTM) across the lifespan. His research focuses on developing better treatments for children and adults with these conditions and examining predictors of long-term outcome with an emphasis on neuroimaging. Dr. Bloch sees children with TS, OCD and TTM as part of the Yale Child Study Center TS/OCD clinic and adults with the same conditions at the Yale OCD Research Clinic. He is also the Assistant Unit Chief at the Clinical Neuroscience Research Unit (CNRU), a comprehensive 12-bed inpatient unit located in the Connecticut Mental Health Center that cares for patients enrolled in several psychiatric research protocols.

In addition, Dr. Bloch is the Associate Training Director of the Child Study Center's innovative psychiatry residency program. The Solnit Integrated Program provides psychiatrists-in-training with the opportunity to integrate general, child and research psychiatry across all stages of their career and will be a major pathway by which the next generation of academic leaders in child psychiatry are developed. Dr. Bloch’s research includes Child Psychiatry; Tourette Syndrome; Obsessive-Compulsive Disorder; Trichotillomania; Meta-Analysis; Neuroimaging; Psychiatry and Psychology. His research focuses on developing better treatments for children and adults with these conditions and examining predictors of long-term outcome with an emphasis on neuroimaging.

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