Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL) has wrapped up preliminary analysis of data from its Phase 2 proof-of-concept clinical trial investigating novel cannabinoid combination drug candidate IHL-42X for the treatment of obstructive sleep apnoea (OSA).
The clinical trial assessed the efficacy of three doses of IHL-42X – compared to a placebo – in reducing the apnoea hypopnoea index (AHI). The AHI is the main diagnostic and monitoring criteria for OSA in patients who suffer from the disease.
Overnight sleep study
A total of 10 recruits completed the trial, receiving each of the three doses of IHL-42X or a placebo across four seven-day treatment periods, separated by one-week washout periods.
At the end of each treatment period, participants attended the clinic for an overnight sleep study where AHI was determined, along with other measures of sleep quality, quality of life and drug safety.
The study was conducted at the University of Western Australia Centre for Sleep Science and The Alfred Hospital in Melbourne.
The crossover design of the study allowed Incannex to generate high quality data with a reduced participant number compared to a conventional parallel arm study. Each participant served as their own internal control and inter-participant variation was eliminated.
The study included ten placebo treatment periods and twenty-six IHL-42X treatment periods totalling thirty-six AHI data points that were compared to baseline.
Promising preliminary results
Preliminary analysis of the study data, comparing the AHI during treatment with IHL-42X across all three dose levels or placebo to baseline, is promising.
At baseline, the average AHI was 42.84. For all IHL-42X treatment periods – using low, mid, and high doses – the average AHI was 23.81, a 44.4% reduction compared to baseline AHI.
During placebo treatment periods, the average AHI was 40.08, a 6.4% reduction compared to baseline.
The results showed that 60% of participants experienced a reduction in AHI of greater than 50% and a resulting AHI of less than 20 during at least one treatment period of one dose strength of IHL-42X, while 20% of participants experienced a reduction in AHI of greater than 80% relative to baseline during at least one treatment period of one dose strength of IHL-42X.
Preliminary analysis also revealed that IHL-42X was observed to be well tolerated in the clinical trial.
All treatment associated adverse events was consistent with what has been reported for constituent components of IHL-42X in historic studies.
The full clinical study report is anticipated in the next quarter of 2022.
Chief scientific officer Mark Bleackley said: “We are delighted that IHL-42X has demonstrated efficacy and good safety characteristics in our preliminary assessment of data from the proof-of-concept trial.”
“The average reduction in AHI calculated across low, mid, and high-dose IHL-42X has met our expectations for what would constitute a valuable product for the treatment of obstructive sleep apnoea.
“IHL-42X has the potential to reduce disease severity, resulting in improved sleep quality, multiple major health benefits and increased quality of life.”
Meeting with the FDA
Incannex is preparing for an investigational new drug (IND) meeting with the US Food and Drug Administration (FDA) on the future development plan for IHL-42X.
The meeting will provide guidance on what data is required to open an IND application with the FDA for IHL-42X for treatment of OSA and the design of a larger pivotal Phase 2 clinical trial with trial sites in the US.