Impression Healthcare prepares for obstructive sleep apnoea clinical trial
Impression Healthcare expects to conduct a clinical trial into sleep apnoea in the June quarter 2020.
Medical cannabis company Impression Healthcare (ASX: IHL) is on course to begin a clinical trial using its IHL-42X drug candidate for the treatment of obstructive sleep apnoea.
The drug was recently the subject of a patent application that facilitates further investment into clinical research.
Earlier today, Impression confirmed that it has now received all relevant permits in order to import key cannabinoid constituents that make up IHL-42X – giving the green light for the company to proceed with its planned phase 1B/2B clinical trial.
Impression also confirmed that it has commenced “sophisticated product formulation development” of IHL-42X, to be used in the upcoming trial.
Given current forecasts, Impression thinks it can get can kick-off the study sometime between April and June this year and has begun to compile precursory data and authorisations required for phases 1B and 2B to go ahead.
The upcoming trial will be based at the Austin Hospital in Melbourne, Victoria, with first patients already sourced.
Recently appointed Impression medical advisory board member and renowned sleep specialist Dr David Cunnington will oversee the trial with an expanded clinical trial protocol.
Impression stated that its expanded protocol will include assessments including the severity of obstructive sleep apnoea, the number of oxygen desaturation episodes that occur during patient nocturnal sleep, plus daytime somnolence and cognitive performance.
If successful, Impression will continue to develop its IHL-42X to treat sleep apnoea – a condition that is currently the second most diagnosed after asthma and the largest cause of chronic pathology for which there is no registered pharmacological treatment.
More broadly and in addition to sleep apnoea, Impression is currently undertaking several clinical programs to develop uniquely formulated medicinal cannabis products for the treatment of traumatic brain injury, temporomandibular joint disorder and gum disease.
Each indication serves as a standalone opportunity to treat a particular ailment and means the multipronged strategy could generate significant sales on a per indication basis for Impression.
The medical cannabis company says that three of the four indications it is seeking to explore do not have existing pharmacological treatments, which raises the possibility of patients receiving government subsidies for products that demonstrate suitable safety and efficacy profiles in clinical trials.
Driving ahead
In addition to its primary endpoints, the upcoming sleep apnoea trial will also include a key secondary endpoint in the form of driving ability.
In a world-first, Impression will gauge whether any constituents of IHL-42X have an impact on a patient’s driving ability, the next day after being consumed.
The driving aspect of the study is seen as a “driver of project value” and will occur at clinically validated driver testing facilities managed by Swinburne University.
As an important step to potentially ensure its long-term development, Impression has confirmed that it has engaged a specialised consultant to commence the registration process with the FDA.
According to Impression, it is likely to apply for registration under an FDA accelerated pathway as this route eliminates the requirement to conduct several pre-clinical steps due to widely accepted publicly available clinical data on certain constituents of IHL-42X.
Also, the accelerated pathway tends to reduce both financial cost and time – expediting the path to registration and commercialisation.