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.
About THX-OSA01:
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.
Forward-Looking Statements
This press release contains forward-looking statements about the Company's expectations, beliefs, and intentions.
Forward-looking statements can be identified by the use of forward-looking words such as "believe", "expect", "intend", "plan",
"may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives
or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical
matters. Such forward-looking statements used in this press release include, among other things, references to the clinical and
commercial potential of THX-OSA01 for the treatment of Obstructive Sleep Apnea. Actual results could differ from those projected
in any forward-looking statements due to numerous factors. Such factors include, among others, our ability to raise the
additional funding needed to continue to pursue our business and product development plans, the inherent uncertainties associated
with developing new products or technologies, our ability to obtain regulatory approval for our product candidates, our ability
to commercialize our product candidates, competition in the industry in which we operate and overall market conditions. Any
forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no
obligation to publicly update or review any forward-looking statement, whether as a result of new information, future
developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks
and uncertainties affecting the Company is contained under the heading "Risk Factors" in Therapix Biosciences Ltd.'s annual
report on Form 20-F dated May 1, 2017 filed with the SEC, which is available on the SEC's website,
www.sec.gov.
For further information:
Investor Contact:
Josh Blacher, CFO, Therapix Biosciences, josh@therapixbio.com
Therapix Biosciences Ltd.
For further information: +972-3-616-7055
Media Contact:
Susan Forman, DGI
+1-212-825-3210
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SOURCE Therapix Biosciences Ltd