IHL-216A is a combination cannabinoid drug to be administered in the immediate period after primary blunt head injury. Incannex is assessing its ability to protect the brain against secondary injury mechanisms that cause neuronal cell death and raised intracranial pressure in the days and weeks following head trauma in sports, and all other applicable scenarios resulting in head trauma (falls, vehicle collisions, violence, combat etc.).
Ablating secondary brain injury may improve positive outcomes for long term neurological sequelae including chronic traumatic encephalopathy (‘CTE’), a major health risk associated with contact sports e.g. MMA, NFL, AFL and NRL.
Incannex has filed patents covering key aspects of IHL-216A to be used as a neuroprotective agent administered post-head trauma. The IHL drug discovery team believes that an optimal fixed dose of APIs within IHL-216A will result in the provision of neuroprotection, defined as reduced neuronal cell death and damage.
Incannex is currently undertaking a comprehensive animal study to formally assess the neuroprotective capability of IHL-216A. The trial introduces rodents to head trauma, implemented consistently in a highly controlled environment to inflict a reproducible injury. Eight separate rodent cohorts will be administered components or combinations of IHL-216A at varying doses soon after the trauma. The rodents will then undertake behavioural tests at various intervals to assess their neurocognitive and motor function. Incannex will also monitor secondary injury cascades, assess structural damage to the brain using magnetic resonance imaging and perform micro-scale cellular analysis post-mortem to discern and compare neuronal damage across the cohorts.
The study is being conducted to discern optimal combination dosages for the upcoming in-human clinical trial in MMA fighting athletes and will contribute to the Company’s FDA data package. IHL-216A is designed to satisfy World Antidoping Authority (‘WADA’) and Australian Anti-Doping Authority’s (‘ASADA’) specifications for use by athletes at risk of TBI and CTE.
Incannex’s animal study being undertaken now and the future MMA fighters clinical trial will contribute to a FDA 505(b)(2) new drug application for exclusive marketability; details of which were released in the announcement on the 03rd of March 2020 and entitled, “IHL-216A (TBI/Concussion) accelerated FDA approval pathway”.