IHL’s novel drug IHL-216A could be the holy grail in concussion treatment, with promising preclinical study results showing it can restore spatial memory.

Clinical stage pharmaceutical company Incannex Healthcare (ASX:IHL) has announced its cannabinoid combination treatment IHL-216A has been observed to have a strong neuroprotective effect in a widely known model of sports concussion.

The preclinical study compared IHL-216A to its component drugs, cannabidiol (CBD) and isoflurane, in a rodent model of sports concussion 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.

The study conducted at the Department of Neuroscience, Monash University compared six groups of 24 Sprague Dawley rats. Rats were tested in a Y-maze task, which assesses spatial memory by determining the rat’s ability to discriminate between a new and familiar arm, 24 hours after injury.

injured animals treated with IHL-216A were found to have no difference in discrimination index compared to uninjured animals. This was in stark contrast to injured animals treated only with the vehicle (placebo).

These findings indicate that the defect in spatial memory observed at 1 day post injury is restored in animals treated with IHL-216A.

Further evidence of IHL-216A’s observed success is that the  animal cohort treated with CBD alone had only intermediate performance in the Y-maze between uninjured animals and vehicle treated injured animals. An interesting finding given that other cannabis companies have pursued the development of neuroprotection tools using only CBD vaping.

Study supports previous observations

The latest findings further support the protective effect of IHL-216A in traumatic brain injury (TBI) and expands upon the 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 the rats relative to CBD. These regions of the brain are known to be important in the formation and storage of memories.

Following all preclinical observations, Incannex is now preparing a pre-Investigational New Drug (IND) meeting package for IHL-216A. The study team is targeting a pre-IND meeting with the US Food and Drug Administration (FDA) in Q3 FY22.

Exciting development in concussion treatment

It’s estimated almost 70 million people incur a TBI every year and there are currently no registered pharmaceutical agents approved for the treatment. Incannex says that the current treatment strategies for TBI are inadequate, ranging from rest in minor TBI and concussion to surgical interventions to deal with hematomas in severe TBI.

Reducing the secondary effects of concussion in sport using a pharmacotherapy may also have implications for how concussion is treated after the game. According to 2017 study on brains of deceased gridiron football players, 99% of tested brains of NFL players and 91% of college football players had various stages of Chronic traumatic encephalopathy (CTE). CTE is a progressive and fatal brain disease associated with repeated blows to the head.

IHL Chief Scientific Officer, Dr Mark Bleackley said the observations of a neuroprotective effect for IHL-216A in an animal model that replicates injuries observed in sports concussion was exciting.

“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,” Bleackley 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”.

IHL achieves key milestones

The observation of IHL-216A as a promising treatment for concussion follows a series of breakthroughs for the company across its product suite.

IHL recently confirmed successful preliminary results for its Phase 2a trial where three doses (low, medium, high) of IHL-42X were assessed for their capacity to reduce apnoea hypopnoea index (AHI), the main diagnostic and monitoring criteria for Obstructive Sleep Apnoea (OSA).

A study into Psilocybin and psychotherapy for Generalised Anxiety Disorder (Psi-GAD) has also kicked off.

The phase 2a Psi-GAD clinical trial is being led by Dr Paul Liknaitzky. The first participants have been enrolled and treatment has commenced in the unique trial, which incorporates a range of treatment innovations currently unseen in the field of psychedelic therapy.

In February, IHL hit the Nasdaq lists under the ticker code IXHL as it aims to strengthen its position in the US market.

The company has also entered a landmark deal to acquire innovative US biotech APIRx Pharmaceutical.

This article was developed in collaboration with Incannex, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.