Incannex trials don't take sleep disorders lying down

Incannex Healthcare (ASX: IHL) has completed preliminary analysis of data from its phase 2, proof-of-concept clinical trial investigating its IHL-42X produced used to treat obstructive sleep apnoea.

Obstructive Sleep Apnoea (OSA) is the most common sleep-related breathing disorder, causing people to repeatedly stop breathing for extended intervals during sleep.

A 2016 study showed that one in ten Australians suffer from undiagnosed OSA, while the statistic could be as high as 49% for males aged 40-69 years.

Clinical trial brief

A total of 11 participants were recruited for the study, each given three doses of IHL-42X across four, seven-day treatment periods.

The key measure for the assessment was the apnoea hypopnoea index (AHI), a monitoring criteria for OSA.

At the end of the treatment period, ten participants completed the treatment and participated in an overnight sleep study where AHI was determined, along with other measures such as sleep quality, quality of life and drug safety. 

Trial results 

At baseline level, the average AHI across participants was 42.84. 

For all IHL-42X treatment periods, the average AHI was 23.81, a 44.4% reduction compared to baseline levels. 

During placebo treatment periods, the average AHI was 40.08, a -6.4% reduction compared to baseline. 

Participant summary: 

• 20% experienced a reduction in AHI of greater than 80% during at least one treatment

• 60% experienced a reduction in AHI greater than 50% during at least one treatment

• IHL-42X observed to be "well tolerated"

“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 obstructive sleep apnoea,” said Chief Scientific Officer Dr Mark Bleackley. 

Next steps

Patient response to low, mid and high IHL-42X doses and other relevant areas continue to be analysed by a contract research organisation, Novotech.

A full clinical study report is anticipated in the second quarter of 2022.

Incannex is also due to meet with the US Food and Drug Administration (FDA) on 11 May. The meeting is expected to provide guidance on what data is required to open an Investigational New Drug application for further trials in the US.

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