Incannex Healthcare has reported positive data from Phase II clinical trial of IHL-42X to treat obstructive sleep apnoea (OSA).
In the proof-of-concept trial that investigated the effect of IHL-42X, the therapy reduced apnoea hypopnoea index (AHI), improved patient reported sleep quality and was also found to be well tolerated.
In the trial, three doses of IHL-42X were evaluated at reducing the AHI in OSA patients.
Additionally, data was also collected for other aspects of sleep quality, THC clearance and safety.
The trial subjects were given each of the three IHL-42X and placebo doses across four seven-day treatment periods, separated by washout periods for a week.
For an overnight sleep study, they attended the clinic at the end of each treatment period, where AHI and other measures of sleep quality, quality of life and drug safety, were determined.
A total of 11 participants took part in the trial, which was carried out at the University of Western Australia Centre for Sleep Science and The Alfred Hospital.
Ten among them completed treatment periods.
The study has a crossover design which allowed Incannex to generate quality data with a reduced participant number against a traditional parallel arm study.
Novotech and the Incannex scientific research team concluded data analysis of the study.
It was observed in the trial that the difference relative to baseline with low dose and medium dose at the group level was statistically significant.
During IHL-42X treatment periods, the reduction in AHI was observed, which means that when treated with Incannex’s drug, the subject’s breathing was less frequently disturbed during sleep.
Furthermore, low dose IHL-42X compared to dronabinol and acetazolamide at equivalent doses resulted in reduction in AHI. This supports Incannex’s hypothesis that the two drugs are acting synergistically to reduce AHI.