Special Report: Clinical-stage pharmaceutical company Incannex Healthcare is working on four different treatments involving medical cannabinoid products – but there’s one in particular that’s turning heads.

Incannex Healthcare chief scientific officer Mark Bleackley promises the Melbourne-based pharmaceutical research company wasn’t looking for attention or to make a political statement when it began researching how well two different politically charged drugs work when combined into a treatment for COVID-19.

Incannex (ASX:IHL) announced this week that the components of its hydroxychloroquine-cannabidiol cocktail worked well on human cells in a test tube study fighting inflammation. In fact, at the higher end of dosages, each drug completely inhibited the production of inflammatory biomarkers after 24 hours. This is important in development of this combination for prevention and treatment of sepsis-associated acute respiratory distress syndrome (ARDS), a leading cause of death in patients with the novel coronavirus.

Hydroxychloroquine has been incredibly political ever since US President Donald Trump and his medical advisors started promoting it as a COVID-19 treatment. And while medical marijuana is gaining acceptance, it’s still a bit controversial as well.

“We didn’t do this because we wanted clicks or we wanted attention,” Dr Bleackley says.

“We’re investing a lot of money and a lot of time into this, to research it robustly and as thoroughly as possible, to see if it has a proper medical benefit.”

While acknowledging that “we’ve really put ourselves in the crosshairs here,” Dr Bleackley says that Incannex’s interest in hydroxychloroquine as a treatment for ARDS predates the American president’s promotion of it.

“I wonder sometimes what it would be like if Trump hadn’t latched on the hydroxychloroquine bandwagon,” Dr Bleackley says.

There’s a huge difference between the results you find if you search for hydroxychloroquine on Google Scholar versus a regular Google search, he says.

“In the mainstream media and non-scientific publications, it’s very polarising. When you look in the scientific literature, it’s a lot more level-headed. Most of the in-human studies have been retrospective studies so we haven’t seen really robust studies as yet”.

The clinical results so far have been varied, Dr Bleackley says, but there are more studies underway.


An understudied drug

Incannex is less interested in hydroxychloroquine because of its anti-viral properties but because of its use as a potent anti-inflammatory.

Also known by its brand name Plaquenil, hydroxychloroquine is used to fight arthritis and lupus because of its anti-inflammatory properties.

As a clinical-stage cannabinoid research company, Incannex specialises in researching medical treatments involved in pharmaceutical-grade medical cannabinoid products.

For decades, the medical properties of cannabis were under-studied because of the legal controversy over the drug, but in research in recent years research has suggested it has a role treating epilepsy, relieving pain and reducing inflammation.

Incannex specialises in how well synthetic cannabinoid products work when combined with other drugs to treat medical diseases or disorders to create synergies. Many complex diseases have multiple symptoms, Dr Bleackley notes.

Also, because of prior research it’s hard to develop intellectual property around a single cannabinoid, but when combining cannabinoids with approved drugs there are opportunities for IP protection and accelerated pathways available for approval, he says.

In addition to ARDS, Incannex is researching how well cannabinoid products work in combination with other drugs to treat obstructive sleep apnoea, traumatic brain injury and temporomandibular joint dysfunction.

Phase 2b clinical trials are scheduled for later this  year at The Alfred Hospital in Melbourne to test the efficacy of Incannex’s cannabinoid based combination in treating obstructive sleep apnoea, while the other drug candidates are in pre-clinical stages.


Hoping to treat more than just COVID

The plan, Dr Bleackley says, is to help take the medical cannabis out of the world of anecdotes and herbs and into the evidence-based standards required by Western medicine.

“We’re treating this like any other clinical trial,” he says of the hydroxychloroquine-cannabidiol cocktail study.

The company hopes the drug combo will prove effective not just against the respiratory distress syndrome caused by the novel coronavirus, but a whole range of inflammatory conditions that can lead to ARDS.

“This is not something that lives and dies with COVID,” Dr Bleackley says,

“We’re treating this with the same rigour and standards as if this was any other drug.

“We’re not claiming this drug is going to save the world – we would like to think that it will help, but it has to be demonstrated empirically, and we really need the evidence before we make any claims that it would.”

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.