Australian medical cannabis company Impression Healthcare (ASX: IHL) has finalised the design of a clinical program to assess novel cannabinoid formula IHL-216A on neurocognitive function after traumatic brain injury and concussion.
The formula is being assessed on its ability to protect the brain against the main injury mechanisms which cause cell death and other negative consequences in the days and weeks following head trauma.
Impression chief medical officer Dr Sud Agarwal said clinical success would infer a wide number of uses, including the possibilities of a long-term “prevention plan” for chronic traumatic encephalopathy (CTE) which can occur after repetitive hits to the head.
“The best evidence available today suggests that CTE is not caused by any single injury, but rather by years of regular brain trauma,” he said.
“By treating concussion in the days following those injuries, IHL-216A will have effectively created a CTE prevention plan which lessens the effects of traumatic brain injury in the short-term [and] potentially lessens the patient’s risk of developing CTE.”
CTE is widespread in contact sports and a critical medical issue for players and sporting organisations such as the Australian Football League and the National Football League.
It has become highly topical in recent days with Graham “Polly” Farmer being the first Australian Rules player to be diagnosed with CTE.
According to Impression, CTE can only be diagnosed during brain examination at autopsy and doctors say the only known risk factor in developing CTE is repetitive head injury.
More and more current and former AFL players have donated their brains to the Australian Sports Brain Bank for research as awareness of the debilitating disease grows.
Impression has planned two variants of IHL-216A for phase 1b and 2b in-human and animal trials.
It has procured high-quality CBD isolate – a powdered cannabidiol extract which is 99% pure and contains the medicinal parts of cannabis – and sourced other APIs and placebo materials with local manufacturers.
Importantly, the products are designed to satisfy World Anti-doping Authority and Australian Anti-Doping Authority specifications for use by elite athletes at risk of traumatic brain injury and CTE.
In-human trials will investigate neurocognitive function for up to 50 Australian MMA fighters who have sustained moderate to severe concussion due to repeated knocks to the head.
Some of those participants will receive IHL-216A and some will receive a placebo.
Concussions will be measured and determined using the FitGuard concussive measuring smart mouthguard and FDA-recognised neurocognitive tests.
The neurocognitive tests cover important aspects of cognition including attention, memory, language, reaction time and perception.
Each fighter will complete baseline tests which will be repeated at various intervals to compare IHL-216A and placebo cohorts.
Along with measuring duration to recovery (often called “return to play”), secondary endpoints will involve assessments of brain activity as defined by an electroencephalogram and an array of brain-injury related blood biomarkers.
Animal trials will provide important supportive data, providing more flexibility in a highly-controlled environment to assess formula variations and post-mortem data resulting from mild, moderate and severe head trauma.
The IHL-216A trials are expected to commence by mid-year.
They will join other clinical programs being conducted by Impression to test medicinal cannabis products for the treatment of obstructive sleep apnoea, temporo-mandibular joint disorder and periodontitis.
Each indication represents major global markets with potentially significant annual sales.
“Three of the indications currently have no existing registered pharmacotherapy (or drug) treatment,” Dr Agarwal said.
“This raises the possibility of patients receiving government subsidies for products which demonstrate suitable safety and efficacy profiles in clinical trials.”