Incannex Healthcare Limited (ASX: IHL) has engaged Fortrea as the contract research organisation (CRO) for management of the IND opening Phase 2/3 clinical trial investigating IHL-42X for treatment of OSA.
The Phase 2/3 clinical trial will assess the safety and efficacy of IHL-42X at the best performing two doses from the proof-of-concept clinical trial, in patients with OSA who are intolerant, non-compliant, or naïve to positive airway pressure, over a 52-week treatment period.
Participants will receive one of IHL-42X, dronabinol, acetazolamide or placebo for the entirety of the study. All participants will complete daily surveys on their sleep quality, attend monthly clinic visits to assess functional outcomes of sleep, cognitive function and other measures of safety and efficacy.
Every three months, overnight polysomnography will be conducted to determine the effect of treatment on the patients’ Apopnea Hypopnea Index score (‘AHI’). All drug treatments will be compared to placebo.
Fortrea, formerly Labcorp Drug Development’s Clinical Development and Commercialization Services, was previously engaged to conduct a 12-week operational feasibility study where the trial design was provided to potential investigators along with a survey to gauge interest in conducting the study and identify any region-specific regulatory hurdles.
This study involved contacting 195 potential trial sites across 14 countries in North America, Europe, South America, and Australasia. Sixty-three sites expressed interest in participating in the IHL-42X study. Incannex is targeting 45 clinical trial sites to be included in the study and recently appointed two highly experienced lead principal investigators to the study.
Fortrea will use its high-value data sets, combined with its technology enabled clinical trial solutions to improve study recruitment, reduce study risk, safeguard data quality, and gain operational insights as the trial progresses.
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%,” Incannex CEO and Managing Director, Joel Latham, said.
“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 allows 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.”
“Fortrea has been a valuable partner to Incannex for a long time over multiple projects and we have full confidence that its team will successfully manage this very important trial. Fortrea’s familiarity with the study and established relationships with potential trial sites will expedite the study start up and site engagement activities.”
