Special Report: Medical cannabis company Incannex Healthcare (ASX:IHL) says a mice study has further vindicated its cannabidiol/hydroxychloroquine combination pharmaceutical drug,  IHL-675A.

The company says the potent anti-inflammatory activity of IHL-675A makes it an excellent candidate to prevent sepsis-associated acute respiratory distress syndrome, such as that caused by COVID-19.

In past in vitro (human cells in a test tube) testing conducted by contract research company Eurofins, the drug combination acted synergistically to inhibit the production of inflammatory cytokines, and now that research has been backed up by a research in a complex animal.

Eleven groups of 10 mice were injected with CBD and hydroxychloroquine alone and in combination, and then injected with lipopolysaccharide to produce an inflammatory response.

IHL-675A worked to reduce inflammation between 26 and 81 per cent better than the mathematically predicted value, again indicating the drug cocktail is working synergistically.

Importantly, IHL-675A worked significantly better at supressing inflammatory cytokines in its experiments than cannabidiol alone, meaning that IHL-675A could eventually be a better alternative to treating inflammation than regular CBD oils.

FDA consultants hired

Incannex has engaged Camargo Pharmaceutical Services LLC to assist the company in preparing for a pre-investigational new drug (Pre-IND) meeting with the Food and Drug Administration, and also hopes to have IHL-675A granted an emergency use authorisation for treating patients with COVID-19.

Camargo has helped shepherd in more than 200 drug approvals and participates in three to six FDA meetings every month, Incannex says.

The Pre-IND meeting will provide Incannex with the ability to seek advice on the most efficient development plan required to submit an investigational drug meeting application and begin clinical studies in the United States, Incannex says.

Incannex has expanded its provisional patent protection to cover a range of other inflammatory diseases that represent additional opportunities for Incannex, which are currently being evaluated.

Obstructive sleep apnoea phase 2 clinical trial

As previously reported, Incannex has also received ethics approval to begin a clinical trial testing its oral drug candidate IHL-42X to treat obstructive sleep apnoea, a condition that affects as many as 30 million people in the USA alone.

The company says its randomised, double-blind, placebo-controlled clinical trial will be held at Alfred Hospital, with patient recruitment expected to begin soon.

Incannex says a positive result in the trial “would be a major valuation inflection point” for the Melbourne-based biotech company.

This article was developed in collaboration with Incannex Healthcare, 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.

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