Press Release-TEL AVIV, Israel, June 5, 2018 -- Therapix Biosciences Ltd., a specialty, clinical-stage pharmaceutical company focusing on the development of cannabinoid-based treatments, announced that on June 05, 2018, the first subject was enrolled for its Phase IIa, sponsor-initiated clinical trial using the Company's cannabinoid-based technology THX-110 for Obstructive Sleep Apnea (OSA), at Assuta Medical Center, the largest private hospital network in Israel.
The OSA Phase IIa proof-of-concept trial, titled "Examining the Efficacy of a Therapeutic Combination of Dronabinol (Pharma-grade ∆9-tetrahydracannabinol) and Palmitoylethanolamide (PEA) for Obstructive Sleep Apnea", is conducted under the leadership of Professor Yaron Dagan, head of the Sleep Medicine Institute at Assuta, and Principal Investigator, Dr. Lilach Kemer. The clinical trial is a single-arm, open-label trial, in which 30 subjects receive one daily treatment of the drug via oral administration and is followed-up for one month with the primary efficacy endpoint evaluating a significant change in the AHI (apnea-hypopnea index – which refers to the severity of sleep apnea as measured during a sleep test), which assesses the quality of sleep before and after treatment. The clinical trial is designed to prove the safety, tolerance and efficacy of the drug's treatment, and to assess its performance in adult patients suffering from symptoms of Obstructive Sleep Apnea.
Adi Zuloff-Shani, Ph.D., Chief Technology Officer of Therapix, said "We are very excited by the potential of our innovative THX-110 to potentially make a difference in OSA treatment and to improve the quality of life outcomes for patients who suffer from OSA. The initiation of this study represents a significant milestone for Therapix Biosciences as it marks the start of the Company's third clinical program. We believe that our rapid progress, from receiving the Israeli Ministry of Health and Ethics committee clearance to initiating patients' enrollment, is indicative of the expertise of our internal team, as well as, the relationships we've built with our investigator partners."
It is estimated by the American Academy of Sleep Medicine (AASM) that 12 percent of the U.S. adult population suffer from OSA, and the economic burden of undiagnosed sleep apnea in the United States alone is at nearly $150 billion annually.
Professor Dagan said "Obstructive Sleep Apnea affects millions of people around the globe at a growing rate, while current treatments such as noninvasive ventilation devices (CPAP) and oral appliances, unfortunately lead to low compliance. We are enthusiastic to be working with Therapix on researching a pharmaceutical alternative for OSA."
"We are looking forward to this trial as Therapix believes it has the potential to demonstrate that THX-110 can treat different medical indications. The positive topline results shown in our phase IIa trial in Tourette syndrome conducted at Yale University, have led us to believe that our novel solution, based on the entourage effect of endocannabinoids, could potentially enhance treatments for unmet needs including OSA," said Ascher Shmulewitz M.D., interim Chief Executive Officer of Therapix.
In order to improve patient compliance and adherence to therapy, Therapix and Maccabi Health Services, the parent organization of Assuta Healthcare System, have entered into a two-year agreement. The Company's agreement with Maccabi Healthcare Services ("Maccabi") provides data-mining research as part of the co-formation of a Center of Excellence for sleep and 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 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); THX-150 for the treatment of infectious diseases; and THX-160 for the treatment of pain. 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 April 30, 2018 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.