Clinical and Pre-Clinical Programs
Repurposing Approved Cannabinoids for New Indications:
- Utilizing FDA approved cannabinoid-based drugs such as Dronabinol (Δ⁹-tetrahydrocannabinol, THC)
- Harnessing the “Entourage Effect” hypothesis, coined by Professor Raphael Mechoulam, by combining Dronabinol with in Palmitoylethanolamide (PEA), a cannabinoid mimetic lipid molecule, for a range of indications of unmet medical needs: Tourette’s Syndrome (TS), Obstructive Sleep Apnea (OSA), chronic pain
- Employing antibacterial qualities of cannabinoids to potentiate ineffective approved antibiotics in battle with Multi Drug Resistant (MDR) bacteria
- Developing innovative synthetic cannabinoids with high CB2 receptor affinity in different pain indications
- Taking advantage of the therapeutic efficacy of ultra-low dose THC in the treatment of Mild Cognitive Impairment (MCI) induced by Traumatic Brain Injury (TBI)
- Developing alternative drug delivery methods for better bioavailability and effectiveness with lower side effects (such as buccal)
Four clinical programs to treat underserved central nervous system disorders
- THX-110: A drug candidate platform for the treatment of symptoms related to Tourette syndrome (TS), as well as Obstructive Sleep Apnea (OSA) and chronic pain.
- The THX-110 program takes a unique approach to cannabinoid formulation using the “Entourage Effect” hypothesis (i.e. in which Endocannabinoid system constituents work synergistically together). THX-110 is a proprietary combination drug based on dronabinol and PEA. PEA is a cannabinoid mimetic lipid molecule, which naturally occurs in various plant and animal sources.
- THX-130: An “Ultra Low-Dose” THC targeting the high value and unserved market of Mild Cognitive Impairment (MCI), using a unique and proprietary drug development and delivery dosage platform.
- THX-150: A drug candidate intended for the treatment of infectious diseases. It consists of a selected antibacterial agent, with THC or a combination of THC and PEA, to potentially exert antimicrobial synergy.
- THX-160: An innovative and proprietary CB2 receptor agonist formulation intended for the treatment of pain. This specific CB2 receptor agonist was synthesized by Professor Raphael Mechoulam, Ph.D.
THX-110, THX-130 and THX-150 are using a 505 (b)(2) regulatory strategy based on prior FDA approval of dronabinol. The 505 (b)(2) strategy entails a relatively lower risk compared with development of new chemical entities, combined with relatively lower development costs and potential faster time to market.