Incannex Healthcare (ASX: IHL) has revealed more positive in vivo research for its IHL-216A drug, this time regarding traumatic brain injury and has filed a patent application to cover this intellectual property.
IHL-216A comprises cannabidiol (CDB) and isoflurane, and was compared against CBD-alone during the in vivo traumatic brain injury trial.
Incannex’s research revealed IHL-216A exhibited “stronger neuroprotective properties” and outperformed CBD.
According to Incannex, the CBD and isoflurane act synergistically to reduce neuronal damage, neuroinflammation and behavioural deficits that result from traumatic brain injury.
The study was undertaken in rodents with an induced injury and a placebo group with 108 rats across treatment groups.
Rats where either treated with CBD and isoflurane alone or with the IHL-216A combination drug.
In post-mortem Nissl staining analysis of rodent brain tissue, it was found IHL-216A outperformed CBD in reducing neuronal damage in hippocampal regions cornu ammonias 1 (CA1) by 53% and CA2 by 60%.
Incannex noted these brain regions are important in the formation and storage of memories.
Additionally, IHL-216A reduced the Iba1 neuroinflammation marker by 35% more than CBD alone and 123% more than just isoflurane.
IHL-216A also outperformed CBD and isoflurane in animal behavioural tests.
Incannex chief executive officer and managing director Joel Latham said the animal study results were “extremely pleasing” and “steadfastly demonstrate significant improvements in the key markets of secondary brain injury” in a controlled environment.
“Our intent is for IHL-216A to be the first line of defence to dampen the short and long-term effects of traumatic brain injury caused by any means, but particularly in contact sports such as the NFL and the major contact sporting codes in Australia where CTE is a growing concern.”
Advancing IHL-216A for traumatic brain injury
As part of the IHL-216A development program, Incannex recently filed an international patent application called Compositions and method for the treatment or prevention of traumatic brain injury.
This will provide Incannex with the ability to pursue patent protection for the drug in treating traumatic brain injury in international jurisdictions.
Official reports from the International Examiner have considered Incannex’s claim for IHL-216A in treating traumatic brain injury to be novel, inventive and meet requirements.
As a result, Incannex is looking at options to expedite patent filings in key jurisdictions as part of its broader intellectual property strategy.
Following the successful in vivo research using IHL-216A in traumatic brain injury, Incannex is evaluating the most efficient clinical trial program so it can then pursue a US Food and Drug Administration new drug application “as quickly as possible”.
Incannex expects to begin the clinical program early next year.