IQI - Incannex appoints CRO ahead of Phase 2/3 sleep apnoea trial
(NewsDirect)
Incannex HealthcareLtd (ASX:IHL, NASDAQ:IXHL) CEO Joel Latham tells Proactive the companyhas engaged Fortrea as the contract research organisation (CRO) tomanage the IND opening Phase 2/3 clinical trial investigating thecompany’s IHL-42X for the treatment of Obstructive Sleep Apnoea(OSA). This Phase 2/3 clinical trial will assess the safety andefficacy of IHL-42X in people with OSA who are intolerant,non-compliant or naïve to continuous positive airway pressure(CPAP).
Lathamsaid, “The initial Phase 2 proof of concept clinical trial overIHL-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 averagepatient oxygen desaturation index of 59.7%, markedly improved sleepquality and a reduction in cardiovascular stress.
"These results weretruly remarkable and now allow for this Phase 2/3 trial to be agenuine long-term safety and efficacy trial.
"If we again observe such remarkable drug efficacy, safelyadministered over the 52 weeks, Incannex is confident that our productwill be marketable."
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