- Incannex Healthcare (IHL) completes the phase two trial of its cannabinoid combination drug IHL-42X
- The drug was used to treat 11 patients with obstructive sleep apnoea, who were given three levels of dosage, plus a placebo
- Results showed patients given the lowest dose had the best outcome, with a significant reduction in the number of times their airways were blocked in the night
- Due to the positive outcome using the lowest dose, it means the company has now overcome the hurdle of treating patients, while keeping their THC levels below the legal limit for driving the following day
- IHL shares are up 7.33 per cent, trading at 40.3 cents at 2:42 pm AEST
The phase two trial of Incannex Healthcare’s (IHL) cannabinoid combination drug IHL-42X on patients with obstructive sleep apnoea (OSA) is now complete, with results showing patients given the lowest dose, had a “substantial clinical benefit.”
The company said this positive outcome with the lowest dose means the amount of THC in the patients’ bloodstream the morning after taking the drug will be low enough to legally drive in countries that have set limits for THC levels while driving.
Incannex said this finding will allow for widespread use of the drug, as the risk of patients potentially being over the legal driving limit of THC levels after taking the drug was a “significant hurdle.”
The trial assessed IHL-42X on 11 patients (10 who completed the trial) with OSA at the University of Western Australia, using three levels of dosage and a placebo, across four, seven day treatment periods.
The aim was to test the patients reduction of their apnoea hypopnoea index (AHI), which is measured by the number of times per hour a subject’s airway is blocked or partially blocked.
The results found dosing at all three levels reduced AHI far greater than the placebo. The baseline percentage of AHI was 42.84 per cent, while a high dose of the drug dropped that number to 27.78 per cent, a medium dose to 22.22 per cent, and a low dose was the most significant, dropping to 21.13 per cent – 50.69 per cent lower than the baseline.
An addition, patients who took the drug, as opposed to the placebo, experienced significant improvement in oxygen saturation levels. Lower oxygen saturation, is a common side-effect of OSA, and contributes to “long-term health consequences.”
The oxygen desaturation index (ODI) was 59.7 per cent lower than the baseline with the low dose, 59 per cent lower in the medium dose, and 28.5 per cent lower in the high dose.
Sleep quality overall and night wakings after taking the drug improved by 49.49 per cent, with 35.8 night wakes in low dose patients, 38.47 per cent with 41.4 wake ups in medium dose patients and 50.13 per cent, with 37.3 wake ups in high dose patients.
In terms of adverse side effects, the low dose patients had 22.2 per cent treatment emergent adverse events (TEAEs) related to taking the drug, compared to 27.3 per cent in the placebo.
However, medium dose was at 44.4 per cent related TEAEs while high dose was 55.6 per cent.
The company says data from this trial shows the potential for IHL-42X to be “an effective and well tolerated treatment for OSA, meeting the unmet needs of millions of people”.
IHL shares were up 7.33 per cent, trading at 40.3 cents at 2:42 pm AEST.