Ann: IHL files Form F-1 registration statement with SEC, page-47

Excellent news...

If you haven't checked it out yet, see the Incannex Healthcare F-1Registration statement: https://docoh.com/filing/1873875/0001213900-21-043470/F1#T14

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IHL-42X in Obstructive Sleep Apnea:

In July 2021, an interim analysis of the data from our ongoing phase 2b double blind randomised placebo-controlled clinical trial was performed and these results have been utilized to support a patent application regarding the methods for the treatment of obstructive sleep apnoea. Additionally, we plan to supply IHL-42X for sale in Australia under the Special Access Scheme for unregistered medicinal synthetic cannabidiol products after the completion of the Phase 2 study and prior to drug registration.

Stage 2 pre-clinical study for IHL-216A (TBI)
We are currently undertaking a second and more-extensive animal study on the protective effect of IHL-216A in sports concussion with the Monash Trauma Group at the Department of Neuroscience, Monash University, Australia. The Monash Trauma Group consists of a team of leading scientists within their respective fields. Their research focuses on the effects, underlying pathophysiological mechanisms, biomarkers, and treatments of trauma related conditions including TBI and concussion as well as other types of neurological diseases, including CTE.

The study is coordinated by Dr Stuart McDonald, an expert in fluid biomarker development for monitoring TBI, Associate Professor Richelle Mychasiuk, an expert in animal models of TBI and their clinical relevance, and Associate Professor Sandy Shultz, an expert in the pathological mechanisms, biomarkers and treatments of TBI and related conditions. The model of TBI being used in this study was developed by Monash University in collaboration with the US National Football League (“NFL”). The results of the study will be used as a precursory data set to inform the pivotal clinical trials required for drug registration.

Appointing Vectura to develop the IHL-216A formulation in parallel with the animal study using the NFL model of concussion will ensure that we are readied with the specific formulation and delivery mechanism required for advancement of a pivotal Phase 2 clinical trial once the Stage 2 in vivo study and formulation is finalized.

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