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Therapix's First-in-Class Therapy Demonstrates Reversal of Age-Related Cognitive Impairment in Pre-Clinical Study
Date:9/27/2017

TEL AVIV, Israel, Sept. 27, 2017 /PRNewswire/ -- Therapix Biosciences Ltd. (Nasdaq: TRPX) ("Therapix" or the "Company"), a specialty, clinical-stage pharmaceutical company focusing on the development of cannabinoid-based drugs, today announced new pre-clinical data generated in the Company's development program for the treatment of Mild Cognitive Impairment, or MCI. Therapix's proprietary ultra-low dose tetrahydrocannabinol ("THC") drug candidate ("THX-ULD01") significantly reversed age-related cognitive impairment in old mice (p=0.01). The pre-clinical animal study was designed and conducted by Professor Yosef Sarne of the Sackler Faculty of Medicine at Tel Aviv University.

"The data from this pre-clinical animal study suggest that extremely low doses of THC, which are devoid of any psychotropic effect and do not induce desensitization, could potentially provide a safe and effective treatment for cognitive decline in aging humans," remarked Professor Sarne.

In the study, old female mice (24-month-old) were injected once with 0.002 mg/kg of THC, which is 3-4 orders of magnitudes lower than doses that induce the conventional cannabinoid effects in mice. These mice performed significantly better than vehicle-treated old mice, and performed similarly to naive young mice aged two months, in six different behavioral assays that measured various aspects of memory and learning. The beneficial effect of THC lasted for at least seven weeks. Professor Sarne added, "the model demonstrated a relatively long-lasting increase in neuroprotection and neuroplasticity, as well as a larger volume and higher tissue density in various regions of the brain of THC-treated old mice as measured by MRI."

Adi Zuloff-Shani, Ph.D., Chief Technology Officer of Therapix, stated, "This promising data obtained by Professor Sarne and his team further demonstrate the clinical and commercial potential of THX-ULD01 for the treatment of MCI. Based on the discovery of significantly improved therapeutic impact at ultra-low doses (ULD) of THC, it is our continued belief that THX-ULD01 has the potential to fulfill the growing unmet medical need in MCI." Dr. Zuloff-Shani continued, "Further, this data echoes similar findings in pre-clinical models that demonstrate the neuroprotective role of ULD THC, which are expected to be followed by human trials for this potential first-in-class therapy."

Professor Sarne's scientific publication detailing these findings, titled, "Reversal of age-related cognitive impairments in mice by an extremely low dose of tetrahydrocannabinol (THC)," was recently accepted for publication in Neurobiology of Aging, and will be presented at the International Association for Cannabinoid Medicines' (IACM) 9th Conference on Cannabinoids in Medicine being held September 29-30, 2017 in Cologne, Germany.

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 on 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-TS01 targets the treatment of Tourette syndrome; and THX-ULD01 targets the high-value and under-served market of mild cognitive impairments. Please visit our website for more information at www.therapixbio.com.

About THX-ULD01:

THX-ULD01 is a proprietary, new, ultra-low dose formulation of dronabinol, or synthetically-conjugated THC, which is intended to provide a treatment for Mild Cognitive Impairment (MCI). TXH-ULD01 is being developed to be delivered either by sublingual or nasal administration. Recent pre-clinical animal studies have found that an ultra-low dose of THC could potentially protect the brain from long-term cognitive impairment, which may be caused by lack of oxygen supply, seizures or use of drugs. Certain pre-clinical studies also suggest that ultra-low doses of THC cause animals to improve performance in behavioral tests that measure learning and memory.

About Mild Cognitive Impairment:

Mild cognitive impairment ("MCI") is an intermediate stage between the expected cognitive decline of normal aging and the more-serious decline of dementia. It can involve problems with memory, language, thinking and judgment that are greater than normal age-related changes. MCI causes cognitive changes that are serious enough to be noticed by the individuals experiencing them, or to other people, but the changes are not severe enough to interfere with daily life or independent function. People with MCI, especially those involving memory problems, are more likely to develop Alzheimer's disease or other dementias than people without MCI. MCI is a widespread condition that increases with age at a rate of 10% among 70–79-year-olds and 25% among 80–89-year-olds. There is currently no FDA approved treatment for MCI.

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-ULD01 for the treatment of MCI. 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

 

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