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