Clinical stage pharmaceutical company Incannex Healthcare (ASX: IHL) has confirmed its drug candidate IHL-216A has been observed to have a strong neuroprotective effect in a widely known model of sports concussion.
The pre-clinical study used by Incannex was developed in collaboration with the US National Football League (NFL) to mimic the type of brain injury (concussion) that occurs in sports.
The study was organised to compare IHL-216A’s component parts (CBD and isoflurane) to IHL-216A, being the combination drug developed by IHL.
Conducted at Monash University’s Department of Neuroscience, the study compared six groups of 24 Sprague Dawley rats which were subject to scaled concussions using a custom built device to mimic collision mechanics similar to those experienced by NFL players.
The rats were tested in a Y-maze task, which assesses spatial memory by determining an animal’s ability to discriminate between a new and familiar arm of the Y structure.
One full day after injury, rats treated with IHL-216A were found to have no difference in discrimination index compared to uninjured animals.
In contrast, an injured group of 24 rodents treated with CBD alone only showed intermediate recovery performance in the Y-maze.
Findings from the study indicate any defects in spatial memory observed 24 hours following injury were restored in animals treated with IHL-216A.
The results further support the protective effects of IHL-216A in traumatic brain injury and expand upon an initial animal study conducted by Incannex in 2020.
In the 2020 study, Incannex observed that IHL-216A outperformed CBD alone by 53% for CA1 and 60% for CA2 parts of the brain, demonstrating less neuronal damage experienced by rodents relative to CBD.
These regions of the brain are known to be important in the formation and storage of memories.
Incannex has now commenced preparation of a pre-investigational new drug (IND) information package for meetings with the US Food and Drug Administration later this year.
Incannex chief scientific officer Dr Mark Bleackley said the study demonstrated the potential for IHL-216A to be a valuable drug in treating sports-related concussion.
“It is exciting that we have observed a neuroprotective effect for IHL-216A in an animal model, which replicates injuries observed in sports concussion… combining the results from our two animal studies indicates [this drug] has the potential to reduce the effects of traumatic brain injuries across the spectrum of injury severity,” he said.
“The data also gives us the confidence to proceed to clinical development, the first step of which is preparing for a pre-IND meeting with the FDA to get confirmation that our proposed clinical development strategy is acceptable.”
Football player brain study
According to a 2017 brain study, 99% of brains belonging to deceased NFL players and 91% of brains from college football players had various stages of chronic traumatic encephalopathy (CTE).
CTE is a progressive and fatal brain disease associated with repeated traumatic brain injuries including concussions and multiple blows to the head.
Symptoms of CTE include memory loss, confusion, impaired judgment, impulse control problems, aggression, depression and, eventually, progressive dementia.
No current treatments for prescription
Dr Bleackley said there are currently no post-concussion drug treatments which doctors can prescribe to sportspeople who experience concussion and traumatic brain injury.
“By reducing the secondary effects of the concussion, the introduction of IHL-216A as a treatment medication may see players return to the field sooner and lower their risk of ongoing concussion symptoms and CTE,” he said.
He said Incannex would target the use of IHL-216A in all forms of concussion and brain trauma, including falls and vehicle accidents.