Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL) CEO Joel Latham tells Proactive the company has engaged Fortrea as the contract research organisation (CRO) to manage the IND opening Phase 2/3 clinical trial investigating the companys IHL-42X for the treatment of Obstructive Sleep Apnoea (OSA). This Phase 2/3 clinical trial will assess the safety and efficacy of IHL-42X in people with OSA who are intolerant, non-compliant or nave to continuous positive airway pressure (CPAP).
Latham said, The initial Phase 2 proof of concept clinical trial over IHL-42X demonstrated an average reduction in our primary end point, AHI of 50.7%, with 25% of subjects having a reduced AHI of >80%.
"Importantly, we also observed a reduction in average patient oxygen desaturation index of 59.7%, markedly improved sleep quality and a reduction in cardiovascular stress.
"These results were truly remarkable and now allow for this Phase 2/3 trial to be a genuine long-term safety and efficacy trial.
"If we again observe such remarkable drug efficacy, safely administered over the 52 weeks, Incannex is confident that our product will be marketable."
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Incannex Healthcare Ltd