Clinical Programs

Therapix Biosciences Issues CEO's Letter to Shareholders

TEL AVIV, Israel, May 15, 2018 /PRNewswire/ -- Therapix Biosciences Ltd. (Nasdaq: TRPX) a specialty, clinical-stage pharmaceutical company focusing on the development of cannabinoid-based treatments, issued today a letter to its shareholders, from the CEO and chairman of the company.

Therapix Biosciences logo

To our shareholders,

"Therapix Biosciences has experienced an encouraging and optimistic start to 2018. Our most significant milestones are detailed in depth below.

All of these activities led to Q2 2018 being an important inflection point in our Company's development as we hope to see the fruits of these efforts in our product pipelines in each of our focus areas in drug development.

In March 2017, we completed our initial public offering in the United States and listed the company's American Depositary Shares on Nasdaq, and following on from this have decided to focus our efforts on building awareness in the U.S.

We therefore announced, last week, that we would be delisting our ordinary shares from the TASE.

Therapix Biosciences has embraced the scientific discoveries of the Chairman of our Scientific Advisory Board, Raphael Mechoulam.

Prof. Mechoulam not only discovered the active ingredients of the Cannabis plant, but also the synergistic effect of the Endocannabinoids system, leading to what he called the "Entourage Effect". 

We believe that Therapix is the only company in the world that combines these discoveries to potentially lead to the next generation of Cannabinoid Therapies. We have focused our efforts on the synergistic effect of our proprietary formulation of the Endocannabinoid-mimetic; PEA, with the Cannabinoid THC.

We believe our Cannabinoid Entourage Platform – one of Therapix's key competitive advantages – is one of the most compelling elements of what we offer and how we differentiate ourselves.

We plan to show that the Therapix Entourage Program is also beneficial for botanical sourced Bioactives. We believe that there is an opportunity to license our technology to leading producers of botanical Cannabinoid products, without cannibalizing our internal programs. 

I am happy to take this opportunity to answer some of your questions about our plans and also would like to thank my Therapix team, our Academic Partners in the U.S., Europe and Israel (Yale, Hannover, HU), and our other Stakeholders for their contributions.

Together, we believe that we are accomplishing great things and I look forward to continued success in the coming year."

Kind Regards,

Ascher Shmulewitz M.D. Ph.D.
Chairman & CEO

Highlights of activities in 2017 and 2018:

In March 2017, we completed our initial public offering in the United States and listed the company's American Depositary Shares on Nasdaq. And by December 2017, we completed, on time and within our budget, the enrollment for a Phase IIa study at Yale University for THX-110 for Tourette Syndrome.

Based on our internal research programs, we expanded the indications for this and in 2018, we intend to initiate two new studies for Obstructive Sleep Apnea ("OSA") and chronic pain.

As part of this initiative, we evaluated the Opioid-sparing effects of Novel Pharmaceutical Cannabinoids discovered by Prof. Mechoulam and we intend to enter into a Licensing Agreement with the Hebrew University, forming a new Subsidiary co-founded with Prof. Mechoulam, to address the dire need for a new class of medications for the treatment of Chronic Pain.

Our commitment to bridge the gap between the use of Cannabinoids and Medical practice, has resulted in the formation of an internal program of Precision Medicine, which we intend to implement through a wholly-owned Subsidiary; Evero Health. The focus of Evero will be in the area of integrative solutions, including cannabinoids for the management of Chronic Pain. We have co-founded a Center-of-Excellence with Maccabi HMO, to focus in the area of sleep and pain. Maccabi has been a pioneer in the area of Data-Mining in Healthcare. We believe that this work, in collaboration with our other Academic Partners will lead to a new understanding of the benefits of combining Cannabinoids with other medications.

We have had positive interactions and communications with the FDA. The result of these interactions is that we were allowed to proceed as projected with the clinical development of THX-110 for Tourette Syndrome. THX-110 potentially will become the first cannabinoid-based medicine for TS, offering alternatives to existing drugs (often associated with significant adverse events for the sufferer).

In March 2018, we were pleased to announce FDA Clearance of an Investigational New Drug (IND) for Phase IIa Clinical Trial of THX-110 in treatment of Chronic Pain. The following month, we announced the top-line positive results for the Tourette study, and we plan to present the full report by June 2018. We believe that our programs are well received by regulatory agencies in the U.S. and Europe.

As part of our community outreach effort, Therapix will be sponsoring the Annual Meeting of the European Society for the Tourette Society, which will take place June 13th-15th in Copenhagen, Denmark. The results of the trial will be presented by principal-investigator Dr. Michael Bloch

This year, we are launching two additional THX-110 clinical trials for (i) Obstructive Sleep Apnea ("OSA") with Assuta Medical Centers, Israel's largest private hospital chain; and (ii) the treatment of Chronic Pain.

Realizing that our Entourage Program is just as important for the botanical sourced products, we are intent to launch a New Program ("THXB-110") based on a proprietary botanical blend of Cannabis for the prevention of Migraines. This program may possibly lead to Licensing Agreements with regional retailers, rather than developing a botanical drug. We continue to develop our Anti-Microbial Program. We are working closely with researchers at the Souraski Medical Center in Tel Aviv and at the Weizmann Institute to develop a better understanding of our findings of an "Entourage Effect" to Antibiotics. The result of this work could potentially lead to repurposing antibiotics for Multi Drug-Resistant strains of bacteria.

Finally, we are encouraged by the pre-clinical findings with our Ultra-Low Dose Cannabinoid Program. This work could potentially lead to a way to address an issue of cognitive deterioration resulting from either Brain Trauma or Brain Aging, in the young and mature adults, respectively.

In summary, we have embarked on trying to solve major medical needs in three areas: (i) CNS; (ii) Infection; and (iii) Pain; and expect to complete enrollment for the Tourette, OSA, and Pain IIa Studies by Q1 2019.

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), for the treatment of Obstructive Sleep Apnea (OSA), and the treatment of Pain; THX-130 for the treatment of Mild Cognitive Impairment (MCI) and Traumatic Brain Injury (TBI); and THX-150 for the treatment of infectious diseases. Please visit our website for more information at www.therapixbio.com

Forward Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Because such statements deal with future events and are based on Therapix's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Therapix could differ materially from those described in or implied by the statements in this press release. For example, forward-looking statements include statements regarding the Company's plans with respect to its clinical trials and its intent to report material developments and information regarding such trials. In addition, historic results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in Therapix Biosciences Ltd.'s Annual Report on Form 20-F filed with the Securities and Exchange Commission (SEC) on May 1, 2017 and in subsequent filings with the SEC. Except as otherwise required by law, Therapix disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.

Investor Contact
Suzanne Lyons,
Investor Relation Director
[email protected]

Media Contact
Sydney Masters
[email protected]
M: 917-584-8385
P: 212-987-6804

 

SOURCE Therapix Biosciences Ltd