Medicinal cannabis company Impression Healthcare (ASX: IHL) has developed a cannabidiol (CBD) based drug that it believes holds potential for the treatment of coronavirus-induced respiratory distress syndrome.
The company today unveiled a novel small molecule therapeutic called IHL-675A, comprised of CBD combined with hydroxychloroquine (a historical treatment for malaria), for the potential treatment of sepsis-associated acute respiratory distress syndrome (ARDS).
Not only is treatment for this condition considered a “major unmet clinical need”, Impression said it is also the leading cause of death associated with COVID-19 infections.
The company has lodged a provisional patent application over IHL-675A for ARDS with the Australian Patent Office and is continuing development activities.
Impression has also engaged a specialist pharmaceutical research organisation to conduct pre-clinical animal testing of the combination drug.
What is sepsis-associated ARDS?
Sepsis-associated ARDS starts with a viral or bacterial infection leading to escalating sepsis and culminating in a cytokine storm (an excessive immune response), of which a portion of patients can develop ARDS.
This syndrome is characterised by widespread inflammation, capillary leakage and pulmonary oedema or ‘wet lung’, resulting in breathing difficulties, rapid breathing, hyperventilation and insufficient levels of oxygen in the circulating blood.
COVID-19 has been known to follow this disease pathway, with respiratory failure ultimately leading to multiple organ failure and death in some cases.
According to Impression, there are currently no registered pharmaceutical agents for the treatment of sepsis-associated ARDS; it is treated with mechanical ventilation and oxygen supplementation in an intensive care unit.
Recently, hydroxychloriquine as a stand alone drug was given emergency use authorisation by the FDA in the doctor’s fight against severe COVID-19 suffering patients.
Anti-inflammatory and immune-modifying potential
The clinical objective of ARDS treatment is to reduce the acute pulmonary inflammatory response, reverse pulmonary oedema and limit lung damage.
An immune response resolution includes both dampening of the inflammation and promoting the immune system regulatory pathways to reverse tissue damage.
According to Impression, cannabinoids display “potent anti-inflammatory agents and they exert their effects through multiple pathways”.
Meanwhile, hydroxychloroquine is believed to prevent viral entry, transport and post-entry events.
Hydroxychloroquine is an immunomodulatory molecule that reduces activation of T-cells and interferes with pro-inflammatory signalling. Hydroxychloroquine also exhibits an antiviral effect and has recently been associated with the attenuation of patients to severe progression of COVID-19,” Impression stated.
Hydroxychloroquine is a medication with a long history used to prevent and treat malaria, as well as rheumatoid arthritis and other autoimmune diseases.
Impression said it is encouraged by the “druggability” properties of IHL-675A, including the high oral bioavailability of hydroxychloroquine and the chemical stability of both it and CBD, assuring long-term shelf storage, as well as the high potency of both active pharmaceutical ingredients.
Firstly, the ability of IHL-675A to reduce cytokine production and hyper-inflammation will be defined in a classic rodent model of sepsis.
This will establish the optimal ratio of the two drugs, establish the potent anti-inflammatory activity of the combination and ability to minimise the cytokine storm, the key mediator of ARDS.
If the effectiveness of IHL-675A in animal studies can be established, FDA consultants Camargo Pharmaceutical Services has advised Impression that IHL-675A will be a strong candidate for FDA Emergency Use Authorisation in treating COVID-19 symptoms.
If early clinical success is achieved, Impression said it will undertake pharmaceutical development of the drug, while complying with regulatory requirements across the seven major markets of the globe, including the US FDA and the European Medicines Agency.