Special Report: Incannex Healthcare (ASX:IHL) has received ethics approval to begin a clinical trial testing its oral cannabinoid drug candidate IHL-42X to treat obstructive sleep apnoea, a condition that affects as many as 30 million people in the USA alone.

The company says its randomised, double-blind, placebo-controlled clinical trial will be held at Alfred Hospital, with patient recruitment expected to begin soon.

Incannex says a positive result in the trial “would be a major valuation inflection point” for the Melbourne-based medcan biotech company.

The clinical trial will be a crossover study, meaning that all participants will receive three different doses along with a placebo, during four different one-week treatment periods. On the final night of each treatment period the subject will visit the sleep clinic at Alfred Hospital for an overnight assessment.

Obstructive sleep apnoea is a major public health problem – and a significant market opportunity for the company.

The condition can cause high blood pressure, coronary artery disease, heart attack, heart failure and stroke.

The main treatment option is a mechanical continuous positive airway pressure (CPAP) device, but many people find using the devices all night uncomfortable and claustrophobic.

In the USA, the annual economic burden of undiagnosed sleep apnoea is estimated at $149.6 billion, while in Australia the economic toll is around $21 billion.

That includes the loss of workdays and morbidity from cardiovascular problems, depression, motor vehicle accidents, workplace accidents and type 2 diabetes associated with sleep apnoea.

There’s no existing drug treatment for sleep apnoea, a major reason why Incannex is so excited about this clinical trial.

‘A significant milestone’

Incannex chief executive Joel Latham calls receipt of ethics approval to start the company’s first in-human clinical trial “a significant milestone for Incannex”.

“A successful drug treatment would be a paradigm shift in obstructive sleep apnoea considering low patient compliance to the current standard of care, the CPAP device. It is an important step in the right direction for patients that, for various reasons, cannot tolerate the cumbersome, mechanical CPAP device.

“Accomplishing this goal with highly credentialed partners, including the Alfred Hospital, speaks to scientific rigour of this project and the dedication of Incannex’s research team as we continue to build upon our clinical and commercial potential.”

Funding for R&D

The company also has 4c exercisable IHLOB ASX listed options expiring on the 30th of September. If all of those options are exercised, and many have been to date, the company will have around $10M in funding for research and development activities.

As previously reported, Incannex is working on three other different treatments involving medical cannabinoid products, including a hydroxycholoroquine-cannabinoid cocktail for patients with severe COVID-19 symptoms and a WADA-compliant cannabinoid theorised to treat concussion and traumatic brain injury.

This article was developed in collaboration with Incannex Healthcare, 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.