Repurposing Approved Cannabinoids for New Indications:
- Using FDA approved compound: Dronabinol (biosynthetic THC)
- Effective as stand-alone or in combination
- Significant benefits of cannabis shown in multiple indications: CNS, pain, cancer, anti-inflammatory, dermatology, psychiatric disorders
Two Clinical Programs to Treat Underserved Central Nervous System Disorders
- THX-TS01: for the treatment of symptoms related to Tourette Syndrome (TS). Several studies show the beneficial effects of THC in treatment of TS patients.
- The THX-TS01 program takes a unique approach to cannabinoid formulation using the “Entourage Effect.” THX-TS01 is a combination drug based on dronabinol, an FDA approved synthetic analog of THC, and PEA, PEA is naturally occurring in various food sources such as egg yolk, soybeans and milk. In parts of Europe, PEA derived products (e.g., Normast® and Pelvilen®) have been marketed as a food for special medical purposes. In April 2015, Health Canada added PEA to its list of Natural Health Products, a class of health products which includes vitamins, mineral supplements, herbal preparations, traditional and homeopathic medicines, probiotics and enzymes.
- Therapix is seeking orphan drug designation to treat TS.
- In a letter dated September 29, 2016, the FDA informed us that our request cannot be granted at this time, and is being held in abeyance until and subject to us providing the FDA additional information pertaining to the overall prevalence of TS in both children and adults, and further clinical data to support our scientific rationale for our request for orphan drug designation within 12 months. We intend to respond within the 12 month period, or during any extension thereof.
- THX-ULD01: targeted to the high value and under-served market of mild cognitive impairment (MCI), using a unique and proprietary drug development platform: The “Ultra Low-Dose.”
Both programs use a 505 (b)(2) regulatory strategy based on prior FDA approval of dronabinol. The 505 (b)(2) strategy entails a relatively low scientific-technological risk compared with development of new chemical entities, combined with relatively low development costs and fast time to market.
Therapix is developing unique nasal and sub-lingual delivery and formulations to optimize efficacy of active cannabinoid compounds. Nasal and sub-lingual administration of THC has been shown to be superior to oral administration.
Approvals for indications such as TS and MCI may lead to applications in several additional therapeutic indications, including pain, cancer, anti-inflammatory, dermatology, and psychiatric disorders.