About Therapix Biosciences — Company Overview

Therapix Biosciences Ltd. (NASDAQTRPXTASETHXBY) a specialty clinical-stage pharma­ceu­tical company special­izing in the devel­op­ment of cannabinoid-based thera­pies, propri­etary formu­la­tion for the treat­ment of CNS and pain disor­ders.

 With this focus, the company is currently engaged in the following drug devel­op­ment programs based on repur­posing an FDA-approved Pharma-grade cannabi­noid (Dronabinol): THX-110 for the treat­ment of Tourette syndrome (TS), for the treat­ment of Obstructive Sleep Apnea (OSA), and for 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.


Rational of  THX-110:

We believe our propri­etary THX-110 drug candi­date takes a unique approach to the treat­ment of Tourette’s Syndrome.

THX-110 is a combi­na­tion drug candi­date based on two compo­nents — THC and PEA, which we believe may induce a reaction known as the “entourage effect” A term coined by Prof. Raphael Mechuolam, who discov­ered THC, who’s a pioneer in cannabis research (known as ‘the grand­fa­ther of cannabis’) and is on our scien­tific board. THX-110 contains: (1) Dronabinol, the active ingre­dient in an FDA approved synthetic analog of tetrahy­dro­cannabinol, or THC, which is the psychoac­tive molecule in the cannabis plant, and (2) palmi­toylethanolamide, or 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 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 cannabi­noid system. The endocannabi­noid is a biolog­ical system, composed of endocannabiniod, which are endoge­nous lipid-bases retro­grade neuro­trans­mit­ters, which bind to cannabi­noid recep­tors, and cannabi­noid recep­tors proteins, that are expressed throughout the mammalian periph­eral and central nervous system (including the brain). 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, we believe 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.


Overview of the Yale trial

The Yale study is a phase IIa, single-arm, open-label study, in which subjects receive once-daily oral treat­ment of the inves­ti­ga­tional drug for 12 weeks. The objec­tive of the clinical study is to prove the safety, toler­a­bility and efficacy of THX-110 in adult patients with Tourette syndrome. The primary efficacy endpoint is the change from baseline to the end of the 12-week treat­ment in the Yale Global Tic Severity Scale Total Tic Score (YGTSS-TTS), which is a clinical measure designed to provide an evalu­a­tion of tic severity. Secondary efficacy endpoints include demon­strating the safety and toler­a­bility of THX-110 and to evaluate its benefit on premon­i­tory urges, quality of life and disease severity.