Incannex (formerly Impression) Healthcare has partnered with The Alfred Hospital to conduct the IHL-42X clinical trial for Obstructive Sleep Apnoea (‘OSA’)

2020-07-09 04:18:06 (AET) by Ring Zhang   252

Incannex Healthcare Limited (ASX: IHL) announced a partnership with Melbourne-based hospital The Alfred to advance its IHL-42X Phase 2b clinical trial for Obstructive Sleep Apnoea diagnosed in adults.

Incannex Healthcare Limited (ASX: IHL) announced a partnership with Melbourne-based hospital The Alfred to advance its IHL-42X Phase 2b clinical trial for Obstructive Sleep Apnoea diagnosed in adults.

The potential development of IHL-42X is significant as it is attempting to address the market in OSA that is estimated to be worth at least US$10billion per annum. At the present time there is NO existing pharmacological (drug) treatment for OSA and IHL-42X represents a world first novel combination drug trial into the treatment of the condition.

Professor Terence O’Brien, who is a World-known clinician and specialist in neurology and clinical pharmacology with extensive experience, was named the Principal Investigator of the trial to lead the study team.

Professor O’Brien was formerly The University of Melbourne’s James Stewart Chair of Medicine and Head of the Department of Medicine at the Royal Melbourne Hospital (2008-17), with expertise in epilepsy and related brain diseases, including traumatic brain injury, brain tumours and neurodegenerative diseases..

The upcoming Phase 2b trial will be based at The Alfred Hospital sleep clinic. A baseline sleep clinic visit will confirm patient OSA diagnoses and establish baseline levels for Apnoea Hypopnea Index (“AHI”) as measured by an overnight polysomnography, and receive treatment with IHL-42X.

The primary endpoint of the clinical trial is the improvement in AHI as measured by an overnight polysomnography. Secondary outcomes include the following:

  • Reduction in oxygen desaturation index (ODI)
  • Daytime somnolence measured by the Epworth Sleepiness Scale
  • Improvement in mood as measured by the POMS (Profile of Moods State), and well-being as measured by the Short Form 36
  • Safety of the IHL-42X combination will be established through adverse event monitoring.

The Alfred Health Ethics Committee will be responsible for the ethical design, review and conduct of human research of the trial. Meetings of the Ethics Committee occur periodically and IHL will register its trial for review by the next registration deadline, which is the 27th of July 2020.

IHL will endeavour to supply IHL-42X for sale in Australia under the Special Access Scheme for unregistered medicinal cannabis products, alongside its existing range of cannabinoid oils and CBD Inhaler. IHL will also proceed to the second Phase 2 ‘Factorial’ clinical trial as it compiles the necessary information for a 505(b)(2) new drug application. Achieving FDA registration would entail market exclusivity over their unique product and acceptance by the medical community.

To ensure the IHL-42X clinical trial meets the requirements of the FDA in relation to site management, data collection, analysis, and safety monitoring, the company has entered into a contract with a full-service Contract Research Organisation Novotech.

Novotech was estabbished in 1996 and has offices in 11 locations across the Asia Pacific region. Novotech acquired Clinical Network Services (CNS), an integrated service group focused on product development headquartered in Australia with offices in New Zealand, the UK and the USA. Novotech has been instrumental in the success of over 1000 Phase I - IV clinical trials for biotechnology companies.

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Source: IHL ASX announcement Incannex Partners with The Alfred and Novotech on IHL-42X Clinical Program for Obstructive Sleep Apnoea



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