Traumatic Brain Injury

IHL-216A Traumatic Brain Injury (TBI)

About

IHL-216A is a novel cannabinoid combination product for treatment of Traumatic Brain Injury (TBI).

Program Overview

  • The long-term consequences of concussion and minor TBI include cognitive deficits, depression and anxiety that can have severe negative consequences on quality of life. These are associated with secondary injury cascades that persist after the initial impact to the brain.
  • Current recommendations after concussion or mTBI are rest and avoiding strenuous activities such as sports, work, and school.
  • IHL-216A combines cannabidiol (CBD) and isoflurane to target inflammatory, oxidative and excitative components of the secondary injury mechanism.
  • Treatment is designed to improve recovery time and decrease the impact of the injury on quality of life.

Development

  • Incannex have demonstrated that the CBD isoflurane combination that comprises IHL-216A reduces molecular, physiological, and functional deficits associated with TBI in a rodent injury model to a greater extent than either drug alone.
  • A formulation for delivery of IHL-216A to humans is currently being developed.
  • IHL-216A will then be assessed for efficacy and safety in a comprehensive clinical development program that will be conducted under an FDA IND.
  • Results from clinical trials will be used to seek approval via the FDA505(b)2 pathway.