TEL AVIV, Israel, March 20, 2018 /PRNewswire/ -- 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, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug application (IND) for THX-110 in the treatment of Chronic Low Back Pain. Therapix expects to commence a Phase IIa clinical trial in the second quarter of 2018.
"We believe that the clearance of this IND by the FDA is a significant milestone for Therapix and for its platform technology THX-110 and for patients suffering from chronic low back pain for whom existing medicines often do not provide adequate relief," stated Adi Zuloff-Shani, Ph.D, Therapix's Chief Technology Officer. "Pain represents an epidemic that is mirrored by the large and growing opioid crisis, which is having an extreme cost in terms of human lives. However, utilizing the power of the 'entourage effect,' which we have previously observed in our proprietary compound in other indications, may allow us to provide a potentially safe and efficacious treatment for chronic low back pain."
The chairman and co-founder of Comprehensive Pain Specialists ("CPS"), Dr. Peter Kroll, one of the nation's largest chain of pain clinics stated, "Our challenge for us as pain specialists is to effectively address the complex issues facing the chronic pain population without perpetuating the opioid crisis. Having opiate-sparing technologies such as this compound for low back pain, one of the conditions we treat most frequently, could potentially mean fewer costly procedures and could avoid the reliance upon high-risk medication protocols. I believe it is vital to have tools like these to continue to treat patients safely and responsibly."
The Phase IIa Clinical Trial titled "Examining the Efficacy of THX-110 [Dronabinol (synthetic Δ9-tetrahydracannabinol) and Palmitoylethanolamide (PEA)] for Chronic Low Back Pain" is a single-arm, open-label trial, in which each subject receives one daily treatment of the drug via oral administration and is followed-up for a period of 6 weeks with an additional 2 weeks follow up after the last study treatment. Approximately 20 subjects are expected to participate and receive the drug in the context of the Clinical Trial at the Comprehensive Research Institute (CRI) in Hendersonville, TN, U.S.A. The primary endpoint of the Clinical Trial is to prove the safety, tolerance and efficacy of THX-110 in the treatment of adult patients suffering from chronic low back pain, with efficacy measured by the improvement of quality of life outcomes. In addition to chronic low back pain, Therapix is conducting a clinical development program for THX-110 in the treatment of Tourette syndrome (TS) and Obstructive Sleep Apnea (OSA).
Ascher Shmulewitz, M.D, Ph.D, Therapix Chairman and interim CEO of Therapix said: "Despite all efforts to reduce the suffering of chronic pain patients, the pharmaceutical industry has had limited success in treating some of the conditions, especially in situations that may be related to endocannaboid deficiency.
"The endocannabinoid system is involved in a host of homeostatic and physiologic functions, including modulation of pain and inflammation. Cannabinoids that act as ligands of the endocannabinoid system exert significant effects in various chronic pain conditions. We believe that the use of THX-110 may be a promising treatment in the management of chronic pain."
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 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.
Forward Looking Statements
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.
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SOURCE Therapix Biosciences Ltd