IHL-42X Obstructive Sleep Apnoea (OSA)
IHL-42X is a novel cannabinoid combination product for treatment of Obstructive Sleep Apnoea (OSA).
- 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.
- It is estimated that 936 million people have OSA globally. (1)
- Estimated sleep apnoea device market in 2021 is USD $3.9 billion. (2)
- 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