Incannex Healthcare (ASX: IHL) has engaged global company Fortrea as the contract research organisation for management of its investigational new drug opening Phase 2/3 clinical trial investigating IHL-42X in the treatment of obstructive sleep apnoea.
The trial will assess the safety and efficacy of IHL-42X at the best performing two doses from a recent proof-of-concept clinical study in patients who are intolerant, non-compliant or naïve to positive airway pressure.
Participants will receive a dose of either IHL-42X, dronabinol, acetazolamide or placebo over a 52-week treatment period.
They will complete daily surveys on sleep quality and 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 IHL-42X treatment on each patient’s apopnea hypopnea index (AHI) score.
Positive results
Incannex managing director Joel Latham said the proof-of-concept trial had positive results.
“It demonstrated an average reduction in our primary end point AHI of 50.7%, with 25% of subjects having a reduced AHI of more than 80%,” he said.
“Importantly, we observed a 59.7% reduction in average patient oxygen desaturation index, markedly improved sleep quality and a reduction in cardiovascular stress… the results were truly remarkable and allow for this Phase 2/3 trial to be a genuine long-term safety and efficacy trial.”
Mr Latham said if the new trial was able to demonstrate similar results, it would increase confidence in the market potential of IHL-42X.
Feasibility study
Fortrea was previously engaged by Incannex to conduct a 12-week operational feasibility study provided to potential investigators along with a survey to gauge their interest in participating in the IHL-42X study and identify any region-specific regulatory hurdles.
The company contacted 195 potential trial sites across 14 countries in North America, Europe, South America and Australasia, with 63 expressing interest in taking part.
Incannex is targeting 45 clinical trial sites to be included in the study and recently appointed two lead principal investigators.
Fortrea said it would use the 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.
“Fortrea has been a valuable partner for a long time over multiple projects and we have full confidence that its team will successfully manage this very important trial,” Mr Latham said.
“We believe the company’s familiarity with our study and established relationships with potential trial sites will expedite the study start-up and site engagement activities.”
