Incannex Healthcare enters trading halt ahead of study results and FDA strategy

Incannex Healthcare trading halt study results FDA strategy ASX IHL
Sepsis-associated acute respiratory distress syndrome is the leading cause of mortality brought on by COVID-19.

Cannabinoid drug development company Incannex Healthcare (ASX: IHL) could be on the cusp of announcing a significant development in its mission to develop workable cannabinoid treatments for a range of illnesses including respiratory distress syndrome, sleep apnoea, severe brain injury.

Just yesterday, the company was placed into a trading halt at its own request with a view of making a significant announcement on Monday next week regarding “results of an in vivo study relevant to the development of IHL-675A and its corresponding FDA regulatory strategy”.

The study for which results should be released on Monday is the final of four preclinical studies. A prior in vitro study on the IHL-675A components, cannabidiol and hydroxychloroquine, demonstrated strong evidence that the components acted synergistically to inhibit production of key inflammatory cytokines.

In the experiment, IHL-675A outperformed cytokine inhibition with CBD by 109% to 767% after 24 hours from drug administration.

The trading halt comes just a day after the company announced the onboarding of consultants Canary Capital, described as a boutique investment management and corporate advisory firm, with recent investment successes in companies such as 3DP and HTG.

For its corporate advisory services, Incannex has agreed to pay Canary 10 million options with a strike price of $0.15 and 10 million options at $0.25 per share. The last traded share price of IHL is $0.115.

The two parties have agreed an initial agreement period of 12 months until November 2021 with Canary promising to “create value through long-term strategic investments”, which it believes have the potential to become leaders in their field and are globally scalable”.

Impending progress on multiple fronts

In September this year, Incannex received ethics approval for a phase 2b clinical trial to study the therapeutic benefits of its lead drug IHL-42X on patients with obstructive sleep apnoea (OSA).

As the first human trial in its accelerated plan for an FDA new drug application, Incannex is hopeful that ongoing development in conjunction with accredited sleep specialist and company chief medical officer  Dr Sud Agarwal, will bear fruit in the form of registering its lead drug with the FDA.

The impending phase 2b trial will be a randomised, double-blind, placebo-controlled dose-ranging clinical trial, treating patients with OSA to assess the therapeutic benefit of IHL-42X at three different dose levels.

Incannex has previously said that a positive result in the trial would be a major valuation inflection point for Incannex as it pursues FDA registration.

The study will be performed at the Alfred Hospital in Melbourne, Australia under the supervision of principal investigator Professor Terry O’Brien with patient recruitment set to begin imminently.

If successful in its upcoming trial and its ultimate goal of registering the drug with the FDA, Incannex will have an opportunity to market the drug into a pharma niche that serves as many as 30 million adults in the US alone.

Globally, it is estimated that as many as 936 million people may be suffering from OSA with increasing levels of obesity coupled with higher longevity the culprits for soaring OSA rates.

Additionally, in late September, Incannex appointed Dr Paul Liknaitzky as a scientific officer advising the board of directors. Dr Liknaitzky has an honours in neuroscience and a PhD in psychology from the University of Melbourne and has a special interest in the study of psychedelic medicine.

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