Incannex recently announced positive results for their hydroxychloroquine-cannabidiol formulation, which can potentially treat the inflammatory conditions associated with COVID-19.
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Incannex Healthcare (ASX:IHL) have certainly been keeping themselves busy throughout this turbulent year. The clinical-stage pharmaceutical company are currently developing and testing four different treatments that contain medical cannabinoid components, with one of these formulations drawing serious attention.
Earlier this week, Incannex announced that their novel drug IHL-675A had achieved positive results in vitro, by inhibiting the release of inflammatory cytokines in human cells. In fact, high doses of this formulation completely inhibited the production of inflammatory biomarkers after 24 hours.
These findings follow on from previous positive results achieved in pre-clinical animal trials in July. These are important developments, as this formulation has shown promise in being a treatment option for sepsis-associated acute respiratory distress syndrome (SAARDS). This syndrome is the leading cause of death in patients diagnosed with COVID-19.
Aside from displaying potential as a treatment for COVID-19 symptoms, another reason this drug has turned heads is due to its composition. The main active components of this formulation from Incannex are hydroxychloroquine and cannabidiol (CBD), which have both gained media attention in the past.
Hydroxychloroquine, in particular, has received political interest, ever since US President Donald Trump and his team of medical advisors started promoting the drug nationally as a treatment for COVID-19. Despite this, Incannex Healthcare's chief scientific officer Mark Bleackly has insisted that the company wasn't looking for attention or trying to make a political statement when it began researching the novel formulation.
"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."
Dr Bleackley also mentions that Incannex Healthcare's interest in hydroxychloroquine predates Trump's promotion of the drug. He notes that the public perception of hydroxychloroquine would probably be different had the US President not latched on to the bandwagon. Because of this, hydroxychloroquine is seen as polarising in the mainstream media, whereas the scientific literature is a lot more pragmatic.
While the early signs for the hydroxychloroquine-cannabidiol formulation are promising, even more studies are underway. These studies are more focused on investigating hydroxychloroquine's potent anti-inflammatory effects rather than its anti-viral potential. Hydroxychloriquine has well-established anti-inflammatory effects, as it already sold under the brand name Plaquenil and prescribed for conditions such as lupus and arthritis.
Although Incannex is currently investigating the potential of hydroxychloroquine, their main specialisation is researching medical treatments that have pharmaceutical-grade cannabinoid components. While prohibition has stalled the research into medical cannabis in the past, recent studies have suggested the phytochemicals within the plant can play a role in the treatment of epilepsy, pain and inflammation.
Incannex also specialises in creating synergistic combinations between cannabinoids and other drugs to treat a range of diseases or disorders, hence the creation of IHL-675A. The main reason for this is that many complex diseases have multiple symptoms that require treatment. This is especially true for inflammatory conditions and respiratory diseases.
Due to prior research occurring in the medical cannabis space, it's hard for biotech companies to develop intellectual property around a single cannabinoid. By combining these cannabinoids with other approved drugs, Incannex can create new IP opportunities, with accelerated approval pathways also a possibility.
In addition to their research on SAARDS, Incannex is also investigating the effects of their self-formulated cannabinoid products in the treatment of obstructive sleep apnoea, traumatic brain injury and temporomandibular joint dysfunction.
Their obstructive sleep apnoea formulation (known as IHL-42X) is scheduled for Phase 2b clinical trials at The Alfred Hospital in Melbourne, later in the year. The trials will be randomized and controlled, using the Apnoea Hypopnea Index (AHI), and focus on the outcomes of sleep quality and patient mood to determine the success of the formulation. The other drug candidates are all in pre-clinical stages.
In regards to IHL-675A, Incannex plans to move ahead with stage 2 of its in vivo animal study, and the company believes that successful results at Stage 2 will make IHL-675A eligible for the FDA's 'emergency use authorization.' While the company hopes that the novel drug combo will be effective in the treatment of SAARDS, they also believe that it will be helpful in the treatment of other inflammatory conditions.
"This is not something that lives and dies with COVID," states Dr Bleackley. "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."
With this new hydroxychloroquine-cannabidiol combination, Incannex Healthcare continues to build an impressive portfolio of formulations. In addition to developing strong business partnerships, Incannex is placing itself at the very forefront of the medicinal cannabis industry within Australia. If all goes to plan, their formulations could provide patients with a range of different conditions with a better quality of life.
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