Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL)'s asset IHL-216A has been observed in a preclinical study to have a strong neuroprotective effect in a widely known model of sports concussion.
The study compared IHL-216A to its component drugs, cannabidiol (CBD) and isoflurane, in a rodent model of sports concussion, comparing six groups of 24 rats.
NFL collaboration on sports-related concussion
The model was developed in collaboration with the US National Football League (NFL) to accurately represent the type of brain injury that occurs in sports-related concussion.
When animals were tested in a Y-maze task, which assesses spatial memory by determining the animal’s ability to discriminate between a novel and familiar arm, 24 hours after injury, those treated with IHL-216A were found to have no difference in discrimination index compared to sham (uninjured) animals.
By contrast, for injured animals treated with either vehicle or isoflurane alone after injury, the discrimination index was significantly reduced compared to sham animals.
The group treated with CBD alone had intermediate performance in the Y-maze between sham and vehicle-treated animals.
Spatial memory “restored”
These findings indicate that the defect in spatial memory observed at one day post-injury is restored in animals treated with IHL-216A.
In this model, concussions experienced by NFL players were scaled to Sprague Dawley rats, according to known biological relationships, to mimic the collision mechanics including high-velocity impact and head acceleration.
The injury was induced using a custom-built device, which provides one of the best-known simulations of sports concussion currently available in a rodent model.
The study was conducted at Monash University’s Department of Neuroscience.
Protective effect
The findings from this study further support the protective effect of IHL-216A in traumatic brain injury and expand upon the initial animal study conducted by Incannex in 2020.
Following current and previous positive preclinical observations, Incannex has commenced preparation of a pre-investigational new drug (IND) package for IHL-216A ahead of a meeting with the US Food and Drug Administration (FDA) scheduled for the third quarter of the year.
The meeting will allow Incannex to present a case to the FDA to conduct an expedited clinical trial program for a new drug application and marketing approval.
Confidence ahead of FDA meeting
Incannex Healthcare chief scientific officer Dr Mark Bleackley said: “It is exciting that we have observed a neuroprotective effect for IHL-216A in an animal model that replicates injuries observed in sports concussion.
“Combining the results from our two animal studies indicates that IHL-216A has the potential to be effective at reducing the effects of traumatic brain injuries across the spectrum of injury severity.
“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.”
About IHL-216A
IHL-216A is a combination drug that combines CBD with any volatile anaesthetic agent, including isoflurane. It has been designed to be administered soon after head trauma to reduce secondary brain injuries that lead to neurological deficits.
Due to the product’s potential therapeutic utility in contact sports, 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 traumatic brain injury (TBI) and Chronic Traumatic Encephalopathy (CTE).
About traumatic brain injury and concussion
Sixty-nine million people are estimated to incur a TBI every year. There are currently no registered pharmaceutical agents approved for the treatment of TBI and current treatment strategies range from rest to surgical interventions to deal with haematomas.
Watch: Incannex Healthcare study targeting concussion reveals neuro-protective properties of treatment