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LONDON, UK / ACCESSWIRE / April 11, 2018 / Active-Investors.com has just released a free research report on Therapix Biosciences Ltd (NASDAQ: TRPX). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/'symbol=TRPX as the Company's latest news hit the wire. On April 09, 2018, the Company announced positive top-line results from its investigator-initiated Phase-IIa study at Yale University, for treatment of Tourette syndrome. The results suggested 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. Register today and get access to over 1,000 Free Research Reports by joining our site below:
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Primary Endpoint was to Assess the Performance of THX-110 in Treatment of Adult Patients Suffering from Tourette Syndrome
The Phase-IIa study was a single-arm, open-label trial, which enrolled 16 subjects and each subject both received one daily treatment of THX-110 via oral administration and was followed-up for a period of 12 weeks. 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.
Subset of the Subjects Experienced Improvement in Tic Symptoms
The study showed that these 16 subjects with medication-refractory TS had a reduction of tic symptoms, resulting 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. Twelve of the 16 subjects elected to continue into a 24-week extension phase of the trial, which is nearing completion.
Complete results from this study will be presented at the 2018 European Society for the Study of Tourette syndrome meeting in Copenhagen, Denmark.
Therapix to Initiate a Study to Evaluate the Safety and Efficacy of Daily Oral THX-110 in Treating Tourette Syndrome
Adi Zuloff-Shani, Ph. D, Chief Technology Officer at Therapix, said that 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.
Dr. Adi added that based on these study results, the Company intends 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.
News report suggests that post the announcement of the news, shares of Therapix surged in pre-market trade.
Therapix Completed Pre-IND Communication with FDA on THX-110 for Tourette Syndrome
On February 07, 2018, Therapix held a pre-Investigational New Drug (pre-IND) communication with the US Food and Drug Administration (FDA) to discuss the regulatory pathway for the development of THX-110 for the treatment of Tourette Syndrome. Following the communication, the Company confirmed that the IND for THX-110 would not require any additional nonclinical data to support a phase-IIb study in the United States. Therapix intends to submit a NDA via the 505(b)(2) pathway.
About Tourette Syndrome
Tourette syndrome (TS) is a common neuropsychiatric disorder with onset in childhood, characterized by multiple motor tics and at least one vocal (phonic) tic. These tics characteristically wax and wane, can be suppressed temporarily, and are typically preceded by an unwanted urge or sensation in the affected muscles. Some common tics are eye blinking, coughing, throat clearing, sniffing, and facial movements. Tourette's does not adversely affect intelligence or life expectancy.
About Therapix Biosciences Ltd
Founded in 2004 and headquartered in Tel Aviv, Israel, Therapix Biosciences Ltd is a specialty clinical-stage pharmaceutical company specializing in the development of cannabinoid-based therapies, proprietary formulation for the treatment of CNS and pain disorders.
Stock Performance Snapshot
April 10, 2018 - At Tuesday's closing bell, Therapix Biosciences' stock tumbled 11.31%, ending the trading session at $5.33.
Volume traded for the day: 227.08 thousand shares, which was above the 3-month average volume of 122.42 thousand shares.
After yesterday's close, Therapix Biosciences' market cap was at $218.52 million.
The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 1.8% at the end of the session.
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