Incannex Healthcare Ltd, a clinical-stage pharmaceutical company developing medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies, has engaged Fortrea as the contract research organization to manage the Investigational New Drug opening phase 2/3 clinical trial investigating IHL-42X for the treatment of obstructive sleep apnea.
The phase 2/3 clinical trial will assess the safety and efficacy of IHL-42X, a cannabinoid combination product, 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 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 treatment on the patients’ apnea hypopnea index (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 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, according to a release from Incannex.
“The initial phase 2 proof-of-concept clinical trial over IHL-42X demonstrated an average reduction in our primary endpoint, 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,” says Incannex CEO and managing director Joel Latham in a release. “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.”
He adds in the release, “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.”
IHL-42X is a synergistic composition of dronabinol, a synthetic form of tetrahydrocannabinol, and acetazolamide, a carbonic anhydrase inhibitor.