Impression Healthcare (ASX: IHL) has confirmed in it quarterly report that it has sourced all permits and products required for the start of animal pre-clinical testing of cannabinoid drug IHL-675A developed to treat sepsis-related adult respiratory distress syndrome (ARDS), which is considered the leading cause of death from COVID-19.
The company is developing the novel small molecule therapeutic – comprising hydroxychloroquine and cannabidiol (CBD) – to meet a major unmet clinical need arising from the coronavirus pandemic.
Earlier this month, Impression lodged patent applications and engaged a specialist research organisation based in Taiwan to conduct the proof of concept animal tests.
Impression this week confirmed the permits and products had been sourced within Taiwan and said it will soon be in a position to provide further details surrounding the commencement of the animal studies.
IHL-675A is being investigated for its ability to treat ARDS, which is a leading cause of mortality associated with COVID-19 and other infections.
Impression’s chief scientific officer Dr Mark Bleackley said the treatment aims to reduce the body’s acute systemic inflammatory response and prevent it from progressing to acute pulmonary oedema (fluid accumulation) and lung parenchymal damage.
“The pathophysiology of ARDS is thought to be secondary to an uncontrolled inflammatory burst (or cytokine storm) which eventually leads to lung tissue damage,” he said.
“We think that by attenuating the magnitude of the inflammatory response, we can prevent the development of ARDS.”
Impression is proposing to use a lower concentration of hydroxychloroquine than that which has been associated with toxicity while preventing the release of pro-inflammatory cytokines through inhibition, or interference with, multiple signalling pathways.
If a successful proof of concept in animal studies can be established, Impression has been advised that IHL-675A could be a suitable candidate for the US Food and Drug Administration’s Emergency Use Authorisation approval channel resulting from COVID-19.
The company said it could then conduct in-human testing concurrent with active patient prescription under EUA and Special Access Schemes globally.
Sleep apnoea study
Also in its March quarterly report, Impression confirmed it had sourced the first patients for a clinical trial into the treatment of obstructive sleep apnoea using cannabinoid formulation IHL-42X.
The company also received a commissioned strategic assessment report from Camargo Pharmaceutical Services confirming IHL-42X as a potential candidate for a new drug approval pathway in the US, subject to successful clinical assessment.
Impression said COVID-19 government restrictions were not expected to delay the start of the trial in the current quarter.
During the March quarter, Impression’s overall sales figures tallied $338,000.
It registered increased sales from medicinal cannabis oils on a month-by-month basis and awaits fulfilment of a long-term, more cost-effective supply chain which will also see the acceleration of patient acquisition.
Impression has multiple offshore wholesale suppliers and is expecting its 5,500 tinctures of medicinal cannabis oils and its first order of 500 CBD inhalers to arrive in the current quarter.
CBD inhalers are reported to be a preferable delivery application for some patients compared to CBD oils as the cannabidiol is delivered to the bloodstream very quickly and bioavailability is much higher.
Higher bioavailability means a smaller dosage is required, which also means fewer side effects.
Impression said the deployment and growth of its Incannex Pharmaceuticals business, which was launched in mid-2019, had been “well timed” given the current COVID-19 situation.