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 has been completed.
- IHL-42X reduced AHI relative to baseline and improved patient reported sleep quality.
- IHL-42X was well tolerated.
- Low dose IHL-42X had the greatest reduction in AHI, 50.7% relative to baseline, and the THC levels were within legal limits for driving the morning after dosing.
- Click here for a presentation of the clinical trial results.
- 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.
Relevant ASX announcements
- 03 June 2022 – IHL-42X for treatment of obstructive sleep apnoea
- 03 June 2022 – Incannex announces positive results from phase 2 clinical trial investigating the effect of IHL-42X for treatment of obstructive sleep apnoea
- 20 Dec 2021 – Incannex completes dosing patients in phase 2 proof-of-concept trial of IHL-42X for the treatment of obstructive sleep apnoea
- 20 Oct 2021 – Incannex engages Procaps to manufacture IHL-42X soft-gel captules in preparation for pivitol clinical trials
- 22 July 2021- IHL-42X patent update & open label extension study approval
- 17 May 2021 – Positive pre-IND meeting with US FDA for IHL-42X for Obstructive Sleep Apnoea
- 11 May 2021- IHL-42X OSA Update
- 24 September 2020- IHL receives ethics approval for phase 2 OSA trial