Therapix Biosciences and Assuta Medical Center to Initiate Clinical Trial in Obstructive Sleep Apnea
Planned Phase IIa Trial Will Expand the Company’s Proprietary Cannabinoid-Based Technology Pipeline to Potentially Treat Three Therapeutic Areas of High Unmet
TEL AVIV, Israel, October 18, 2017 /PRNewswire/ — Therapix Biosciences Ltd. (Nasdaq: TRPX) (“Therapix” or the “Company”), a specialty, clinical-stage pharmaceutical company focusing on the development of cannabinoid-based treatments, signed an agreement with Assuta Medical Center, the largest hospital network and private healthcare provider in Israel, to conduct a Phase IIa, sponsor-initiated trial (the “OSA Trial”) for the treatment of Obstructive Sleep Apnea (“OSA”) using the Company’s proprietary cannabinoid-based technology, THX-OSA01.
The OSA trial, titled “Examining the Efficacy of a Therapeutic Combination of Dronabinol (synthetic ∆9-tetrahydracannabinol) and Palmitoylethanolamide for Obstructive Sleep Apnea,” will be conducted under the leadership of Professor Yaron Dagan, head of the Sleep Medicine Institute at Assuta, and Principal Investigator, Dr. Lilach Kemer. Thirty patients with a confirmed OSA diagnosis will be evaluated for one month with the primary efficacy endpoint evaluating a significant change in the AHI Index, which assesses the quality of sleep before and after treatment.
Professor Dagan said, “Breathing sleep disorders affect a substantial and growing percentage of the adult population. Currently, the standard treatments for obstructive sleep apnea (OSA) are noninvasive ventilation devices (CPAP) and oral appliances that are very inconvenient to the patient, thus result in low compliance. There are currently no approved pharmaceutical approaches. As such, we are enthusiastic to be working with Therapix in its development of a potentially transformational therapy in this area of high unmet medical need.”
Dronabinol, one component of THX-OSA01 and an exogenous CB1 and CB2 receptor agonist, has been shown in a proof-of-concept study by an independent group to potentially reduce abnormal respiratory events and associated hypoxemia in patients with OSA. In a study, conducted by researchers from the department of medicine at the University of Illinois, Chicago, in 17 adults with moderate-to-severe OSA, dronabinol significantly reduced the apnea-hypopnea index (“AHI Index”).
Adi Zuloff-Shani, Ph.D., Chief Technology Officer of Therapix, said, “We are excited to collaborate with Professor Dagan, a recognized key opinion leader and world-renowned expert in sleep medicine. A main point of interest in this trial will be investigating the power of the ‘entourage effect,’ which we have previously observed in our proprietary compound in other indications, to enhance the treatment of OSA. We believe the benefits of this effect, in which the two cannabinoids, tetrahydracannabinol (THC) and palmitoylethanolamide (PEA) work synergistically, ensure this trial will expand our knowledge of the utility of THX-OSA01 as a potential OSA treatment.”
Josh Blacher, Chief Financial Officer of Therapix, said, “In addition to the potential commercial opportunities we believe may lie ahead of us in our proprietary treatments for Tourette syndrome and Traumatic Brain Injury, our exploration of the OSA market is a third indication that may have potential to be commercialized in the future if our clinical trials are successful.”
According to the American Academy of Sleep Medicine (AASM) and Frost & Sullivan, a global research and consulting firm, OSA affects 29.4 million American men and women, which represents 12 percent of the U.S. adult population and the economic burden of undiagnosed sleep apnea in United States alone is estimated at nearly $150 billion annually by Frost & Sullivan.
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 two internal drug development programs based on repurposing an FDA approved synthetic cannabinoid (dronabinol): THX-OCA01 targets the treatment of the symptoms of Tourette Syndrome; and THX-ULD01 targets the high-value and under-served market of mild cognitive impairments and Traumatic Brain Injury (TBI). Please visit our website for more information at www.therapixbio.com.
THX-OCA01 is a drug candidate for the treatment of the symptoms of obstructive sleep apnea and it is based on two components: (1) dronabinol, the active ingredient in an FDA approved synthetic analog of tetrahydrocannabinol (“THC”), which is the psychoactive molecule in the cannabis plant, and (2) palmitoylethanolamide (“PEA”), which is an endogenous fatty acid amide that belongs to the class of nuclear factor agonists, which are proteins that regulate the expression of genes. The combination of THC and PEA may induce a reaction known as the “entourage effect.” The basic tenet of the entourage effect is that cannabinoids work together, or possess synergy, and affect the body in a mechanism similar to the body’s own endocannabinoid system, which is a group of molecules and receptors in the brain that mediates the psychoactive effects of cannabis. This entourage effect may account for the pharmacological actions of PEA. Based on an activity enhancement of other physiological compounds, PEA may indirectly stimulate the cannabinoid receptors by potentiating their affinity for a receptor or by inhibiting their metabolic degradation, and by doing so, may increase the uptake of cannabinoid compounds, such as THC. Thus, it is speculated that the presence of the PEA molecule likely increases the efficacy of orally administered THC, while reducing the required dosage and decreasing associated deleterious adverse events.
About Obstructive Sleep Apnea:
According to the Mayo Clinic, obstructive sleep apnea, or OCA, is a potentially serious sleep disorder. It causes breathing to repeatedly stop and start during sleep. There are several types of sleep apnea, but the most common is obstructive sleep apnea. This type of apnea occurs when your throat muscles intermittently relax and block your airway during sleep. A noticeable sign of obstructive sleep apnea is snoring. OSA affects 29.4 million American men and women, which represents 12 percent of the U.S. adult population, according to The American Academy of Sleep Medicine (AASM) and Frost & Sullivan.