Impression Healthcare (IHL) has received all permits needed to begin a clinical trial for IHL-42X in treating obstructive sleep apnoea (OSA).

OSA occurs when the airway at the back of the mouth is partly or completely obstructed during sleep. Breathing is then reduced or may stop altogether.

The oxygen level declines and the sleeper then wakes up and starts breathing again.

Current treatments include weight loss, decreasing alcohol intake and sleeping on the side. In more serious cases, surgery and the use of an oral device is to be prescribed.

Simultaneously, Impression has begun sophisticated product formulation development of IHL-42X to be used in upcoming clinical trial activities.

The company has also started putting together precursory data and authorisations required for a phase 1B/2B clinical trial. This is planned to begin in the second quarter of 2020.

Sleep specialist and IHL board member Dr David Cunnington has assisted in sourcing patients for the trial.

In the trial, the company will observe the severity of OSA measured by the Aponea-Hypopnea Index, number of oxygen desaturation episodes that occur, daytime excess drowsiness and cognitive performance.

This study will be a world first and will occur at facilities managed by Swinburne University.

Impression has also engaged an FDA (Food and Drug Administration) consultant to commence the FDA registration process.

Doing this will eliminate the need to conduct certain pre-clinical steps due to widely accepted publicly available clinical data on certain components of IHL-42X.

The accelerated pathway reduces both time and cost over the life of the clinical trial process to registration and marketability.

During January, Dr Mark Bleakley was appointed to the role of Chief Scientific Officer to manage the OSA and other clinical programs and will work alongside Dr Sud Agarwal and Dr David Cunnington.

Dr Mark has a PhD in Cell Biology and Genetics from the University of British Columbia.

He has already demonstrated his clinical proficiency at Impression and is a suitable replacement to John Michailidis who is unable to complete his contract due to personal reasons.

Impression's share price is down 1.47 per cent with shares trading for 6.7 cents apiece at midday trade AEDT.

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Impression Healthcare (ASX:IHL) receives all permits to begin OSA trial - The Market Herald