The medicinal cannabis and psychedelic clinical development company has achieved a significant milestone for both the company and sector with positive results from a trial using its novel cannabinoid combination in patients with  obstructive sleep apnoea.

Incannex Healthcare (ASX:IHL) conducted the phase 2 clinical trial at the University of Western Australia Centre for Sleep Science and the Alfred Hospital. It looked at three different doses of IHL-42X at reducing the apnoea hypopnoea index (AHI), which is the diagnostic and monitoring criteria for OSA.

Trial participants received each of the three doses of IHL-42X and 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, drug safety and quality of life.


Substantial reduction in AHI

IHL has undertaken preliminary analysis of the study data comparing the AHI during treatment with IHL-42X across all three dose levels or placebo to baseline.

At baseline, the average patient 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.


Clear impact

The study showed that 60% of participants experienced a reduction in AHI of greater than 55% and a resulting AHI of less than 20 during at least one treatment period of one dose strength of IHL-42X.

Furthermore, 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. The best result in fact showed a 91.5% reduction in AHI after one dose.

Specific data from the study, including which IHL-42X doses were received by which patient and when, remain blinded

Patient response to specific IHL-42X doses (low, mid, and high) and the secondary endpoints continue to be analysed by contract research organisation, Novotech and will be released to IHL upon completion of analysis as per usual clinical trial processes.

Analysis will include a comparison between IHL-42X doses for each patient, which increases the power of the analysis, and provides a more robust differentiation of dose strengths.

The full clinical study report is anticipated in Q2 FY22.


OSA a major health problem

OSA is a serious medical condition and the most common sleep-related breathing disorder, causing people to repeatedly stop and start breathing for elongated intervals during sleep.

Many people with OSA develop high blood pressure (hypertension), which can increase the risk of heart disease. The more severe the OSA, the greater the risk of coronary artery disease, heart attacks, heart failure and strokes.

People with OSA often have severe daytime drowsiness, fatigue, and irritability due to lack of restorative sleep at night, which are observed causes of workplace accidents. Those diagnosed with OSA are also at higher risk of memory problems, headaches, mood swings and depression.

The results could be one of the most significant clinical trial results in the medicinal cannabis sector since British-based GW Pharmaceuticals for its product for epilepsy, called EPIDIOLEX in 2016.


The only OSA solution

OSA is highly prevalent, affecting ~30 million adults in the US alone. It is estimated that the annual economic burden of undiagnosed sleep apnoea among US adults is approximately US$149.6 billion.

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.

As a major public health issue, IHL-42X represents a significant commercial opportunity for IHL – as there’s currently no single approved pharmacotherapy treatments available to patients.

The current standard of care is a continuous positive airway pressure (CPAP) machine, however, patient compliance to CPAP is low due to discomfort and claustrophobia resulting from pressurized air being pumped into the mouth during sleep.

However, regardless of the discomfort, the global annual market for OSA detection and treatment using CPAP and other breathing aids is ~US$10 billion annually and growing.


US FDA approval and further trial plans underway

IHL Chief Scientific Officer Dr Mark Bleackley said 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 OSA.

“IHL-42X has the potential to reduce disease severity, resulting in improved sleep quality, multiple major health benefits and increased quality of life. We look forward to the further analysis of the study data by Novotech, which will include identification of which dose strength performed best,” he said.

Bleackley said IHL is preparing for a pre-IND meeting with the US Food and Drug Administration (FDA) on the future development plan for IHL-42X with the company, its medical and scientific advisors granted a meeting via teleconference on May 11, 2022.

“This meeting will provide guidance on what data is required to open an Investigational New Drug (IND) application with FDA for IHL-42X for treatment of OSA and the design of a larger pivotal phase 2 clinical trial with trial sites in the United States,” he added.

“The Board of Directors has progressed its initiative to offer a bonus option entitlement to both reward shareholders and provide additional funding for the Company in the future.”

The terms of this entitlement offer are expected to be decided and announced soon.

This article was developed in collaboration with Incannex, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.