TEL AVIV, Israel, Feb. 7, 2018 /PRNewswire/ -- Therapix
Biosciences Ltd. (Nasdaq: TRPX) ("Therapix" or the "Company"), a
specialty clinical-stage pharmaceutical company focusing on the
development of cannabinoid-based treatments, announced today that
it has held a pre-Investigational New Drug (pre-IND) communication
with the U.S. Food and Drug Administration (FDA) to discuss the
regulatory pathway for the development of THX-110 for the treatment
of Tourette Syndrome.
"Following this informative communication with the FDA, we can
confirm that the IND for THX-110 will not require any additional
nonclinical data to support a phase IIb study in the the United States. We intend to submit the a
NDA via the 505(b)(2) pathway. We believe that this enables us to
continue our clinical program with minimum risk, which is
consistent with our platform of repurposing and reformulating for
unmet and under-served needs for Tourette Syndrome. We expect to
evaluate THX-110 in a phase IIb clinical study in the second
quarter of 2018," said Dr. Adi Zuloff-Shani, Chief Technology
Officer at Therapix.
"THX-110 has the potential to become the first cannabinoid based
medicine for Tourette Syndrome. Currently, two antipsychotic agents
are the only FDA-approved medications for this neurological
disorder: Haloperidol and Pimozide. However, these drugs are also
often associated with significant adverse events," said Dr.
Ascher Shmulewitz, Chairman and
interim CEO of Therapix. "If approved, THX-110 could provide people
who suffer from Tourette Syndrome with a treatment alternative to
the antipsychotic agents," Dr. Shmulewitz added.
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); THX-130 for
the treatment of Mild Cognitive Impairment (MCI) and Traumatic
Brain Injury (TBI); THX-120 for the treatment of Obstructive Sleep
Apnea (OSA); and THX-150 for the treatment of infectious
diseases.
Please visit our website for more information
at www.therapixbio.com
About THX-110
THX-110 is a combination drug candidate
for the treatment of Tourette syndrome and Obstructive Sleep Apnea.
It is based on two components: (1) dronabinol (an FDA approved
synthetic analog of ∆9-tetrahydracannabinol, or "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 could increase the efficacy of orally
administered THC, while reducing the required dosage and decreasing
associated deleterious adverse events.
About Tourette Syndrome
Tourette Syndrome (TS) is a
neuropsychiatric disorder, characterized by physical (motor) tics
and vocal (phonic) tics. Motor or phonic tics are sudden, brief,
intermittent, involuntary or semi-voluntary movements or sounds,
respectively. They typically consist of brief, coordinated,
repetitive movements, gestures, or utterances that mimic fragments
of normal behavior. Tic symptoms of TS typically manifest between 4
and 6 years of age, and peak in severity between the ages of 10 and
12 years. However, they often improve over the course of
adolescence. Motor tics generally precede the development of phonic
tics in TS, and the onset of simple tics usually predates that of
complex tics.
TS appears in a wide range of tics severity, from mild symptoms
that do not cause serious impairment and often go unnoticed, to
loud noises and forceful movements that can result in self-injury.
Many with TS experience additional neurobehavioral problems and
co-morbidities including OCD and ADHD.
The most severe cases of the disease are often observed in
adults. The persistence of the disease into adulthood may have
serious consequences that may include self-injurious tics and those
that cause social unease, such as echolalia (repeating other
people's words), and coprolalia (uttering swear words).
Reports on TS adults who exhibited poor response to medications and
were hospitalized due to deterioration of their clinical state
further support the deleterious effect of the disease in adult
patients.
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 product candidates. 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:
Oz
Adler
+972-3-616-7055
oz@therapixbio.com
Media Contact:
Sydney
Masters
+1-212-987-6804
SydneyMasters2@yahoo.com
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SOURCE Therapix Biosciences Ltd