Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL) has engaged Fortrea as the contract research organisation (CRO) to manage the IND opening Phase 2/3 clinical trial investigating the company’s 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 naïve to continuous positive airway pressure (CPAP).
It will assess the safety and efficacy of IHL-42X at the best performing two doses from the proof-of-concept clinical trial over a 52-week treatment period and will be extensive, conducted across 45 sites, including many in the United States.
Fortrea technology
Fortrea will implement its technology-enabled clinical trial solutions designed to increase drug development efficiency, reduce timelines and improve compliance.
Incannex CEO and managing director Joel 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."
Economic opportunity
Incannex is a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs.
There are no registered pharmacotherapy (drug) treatments available to people with OSA, representing a major economic opportunity to Incannex with IHL-42X, should the study achieve its endpoints as in the proof of concept trial.
About the trial
Participants will receive one of IHL-42X, dronabinol, acetazolamide or placebo for the entirety of the study. IHL-42X is a synergistic composition of dronabinol, a synthetic form of Tetrahydrocannabinol (THC), and acetazolamide, a Carbonic anhydrase inhibitor.
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.
Previous study success
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 and 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.
As the CRO, 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.
“A valuable partner”
“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,” Latham said.
"Fortrea’s familiarity with the study and established relationships with potential trial sites will expedite the study start-up and site engagement activities.”
About Obstructive Sleep Apnoea
OSA is the most common sleep-related breathing disorder. It involves the narrowing of the upper airway during sleep, interfering with a person’s breathing, decreasing oxygen uptake, resulting in poor-quality sleep.
Untreated OSA leads to serious long-term adverse health outcomes including hypertension, cardiovascular disease, heart attack, cognitive impairments, anxiety and depression, irritability and daytime fatigue increasing the risk of accidents. There are no pharmacotherapy (drug) treatments available to those afflicted.
OSA is highly prevalent, affecting approximately 30 million adults in the United States alone. It is estimated that the annual economic burden of undiagnosed sleep apnoea among US adults is approximately US$149.6 billion per annum.
These costs include US$86.9 billion in lost productivity, US$26.2 billion in motor vehicle accidents and US$6.5 billion in workplace accidents.