Clinical stage cannabinoid development company, Incannex Healthcare Limited (ASX: IHL) has partnered with the Monash Trauma Group at the Department of Neuroscience to conduct an extensive in vivo study in relation to the neuroprotective capability of IHL- 216A; a proprietary combination pharmacotherapy (drug) comprising cannabidiol (CBD) and isoflurane.
The study will use a unique model of traumatic brain injury (TBI) that 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.
In this model, concussions experienced by NFL players have been scaled to Sprague Dawley rats, according to known biological relationships, to mimic the collision mechanics including high velocity impact and head acceleration. The injury is induced using a custom-built device, which provides the best-known simulation of sports concussion currently available in a rodent model.
This NFL concussion model study will expand upon the initial in vivo study undertaken by Incannex in 2020, the results of which were announced in December 2020.The protective effect of IHL-216A will again be compared to CBD, isoflurane, and vehicle across a range of behavioural, physiological, and molecular analyses that assess the damage caused by TBI.
CEO and Managing Director, Joel Latham, said the study has been designed according to Good Laboratory Practices; a framework within which laboratory studies are planned, performed, monitored, and reported. Should the Company receive positive results, the thoroughness of this study means that Incannex will be able to proceed directly to a pivotal Phase 2 clinical trial, eliminating the need to run a preliminary proof of concept clinical trial as originally planned.
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,” Mr Latham said.
“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.”
IHL-216A is a combination drug that combines CBD with any volatile anaesthetic agent, including isoflurane. IHL-216A 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 the World Anti-doping Authority (WADA) and Australian Anti-Doping Authority’s (ASADA) specifications for use by athletes at risk of TBI and Chronic Traumatic Encephalopathy, otherwise known as CTE.
IHL-216A components, CBD and isoflurane, have previously been found by Incannex to act synergistically to reduce neuronal damage, neuroinflammation and behavioural deficits that are consequences of TBI.
In experiments, IHL-216A outperformed CBD in reducing neuronal damage in post-mortem Nissl staining analysis of brain tissue by 53% for CA1 and 60% for CA2 in the hippocampal region of the brain. IHL-216A reduced the Iba1 neuroinflammation marker by 35% more than CBD alone and 123% more than isoflurane administered alone.
