Obstructive Sleep Apnoea

IHL-42X Obstructive Sleep Apnoea (OSA)

About

IHL-42X is a novel cannabinoid combination product for treatment of Obstructive Sleep Apnoea (OSA).

Program Overview

  • People suffering from OSA have multiple interruptions in their breathing while asleep, which decreases oxygen uptake and has a detrimental effect on sleep quality. In turn this leads to daytime sleepiness and other consequences associated with poor sleep.
  • Current treatment options such as CPAP and dental devices have poor patient compliance due to discomfort and inconvenience. There are no FDA approved pharmacotherapies for OSA.
  • The two active pharmaceutical ingredients in IHL-42X, dronabinol (synthetic THC) and acetazolamide, each target a different component of the OSA pathology. Dual mechanisms of action mean there is the potential for a synergistic therapeutic effect. This could also lead to the benefit being achieved at lower dose levels, minimising potential side effects.
  • An effective pharmacotherapy for OSA will not only improve sleep and alertness but is also predicted to decrease the health risks associated with OSA including cardiovascular disease, depression, and cognitive deficits.

 

Addressable Market

  • It is estimated that 936 million people have OSA globally. (1)
  • Estimated sleep apnoea device market in 2021 is USD $3.9 billion. (2)

 

 

1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7007763/

2. https://www.grandviewresearch.com/industry-analysis/sleep-apnea-devices-market/

Development

  • A proof-of-concept clinical trial is currently underway at two sites in Australia.
  • Multi-site, international Phase 2 and Phase 3 clinical trials performed under an FDA IND will follow in coming years.
  • Approval will be sought under the FDA505(b)2 pathway and then expanded globally