Clinical and Pre-Clinical Programs

Research and Development

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.