Therapix Biosciences Ltd. (NASDAQ: TRPX; TASE: THXBY) 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.