Incannex Healthcare (ASX: IHL) has revealed it will work with Monash Trauma Group on an “extensive” in vivo study evaluating the protective effect of IHL-216A in sports concussion.
Monash Trauma Group is a specialised team of academic researchers at Monash University’s Department of Neuroscience. The team will collaborate with Incannex on the research, which will use a unique model of traumatic brain injury (TBI).
The unique TBI model has been develop with the US National Football League (NFL) to “accurately represent the type of brain injury that occurs in sports related concussion”.
This model was based on scaling NFL player concussions to large Sprague Dawley rats in accordance to known biological relationships.
The injury to the model is given with a custom-built device to mimic the collision mechanics including high velocity impact and head acceleration.
Incannex said the device provides the best-known simulation of sports concussion injury available in a rat model.
IHL-216A is a combination of cannabidiol and isoflurane and this research aims to compare the protective effect of IHL-216A to CBD, isoflurane (both as individual treatments) and a vehicle.
A range of behavioural, physiological and molecular evaluations will be done to assess the TBI damage.
This information will then feed into clinical trial planning and is required for drug registration.
Incannex noted this step negates the need to carry out an in-human proof-of-concept study, which can save time and expense.
“Undertaking this extensive and well-recognised animal model study, instead of the in-human proof of concept study, has the effect of reducing the overall development time and expense associated with our drug registration plan,” Incannex managing director and chief executive officer Joel Latham explained.
“Furthermore, the company will collect additional data from an animal study that it would not be able to compile in human studies.”
“This additional data will inform the design and end points of our pivotal clinical trials,” Mr Latham added.
Previous positive in vivo study
This latest study expands on Incannex’s in vivo research using IHL-216A on TBI in 2020 which yielded “positive results”.
It found the CBD and isoflurane acted “synergistically” to reduce neuronal damage, neuroinflammation and behavioural deficits that commonly result from TBI.
The study showed IHL-216A exhibited stronger neuroprotective properties than CBD alone. An interesting finding as some elite athletes have been known to use CBD post-match.
Most famously, is Nate Diaz from the MMA, who has previously been seen inhaling CBD vape pens in post-match press interviews.