Novel sleep apnoea treatment to challenge medtech industry norms

MedTech & Diagnostics News: Melbourne’s clinical-stage pharmaceutical company has taken a leap forward in its pursuit to alleviate the burdens of obstructive sleep apnoea (OSA) sufferers, while potentially disrupting the multi-billion dollar medical device market.

However, the path to revolution is not without its fair share of scepticism. Traditional treatments, including the widely prescribed Continuous Positive Airway Pressure (CPAP) Therapy and oral medical devices, have long been the go-to methods for managing OSA. The global sleep apnoea medical devices market, valued at an estimated US$5.8 billion (A$8.4 billion) in 2023, has been dominated by industry leaders like Philips and ResMed.

In 2021, however, Philips issued a global recall of its first-generation DreamStation, System One, and DreamStation Go devices, affecting around 4.3 million registered devices worldwide. This has led to ResMed’s recently reported revenue growth of 29% driven by increased demand for the sleep and respiratory care devices as well as reduced competitive supply.

Incannex Healthcare has made significant progress with its development of oral IHL-42X, a cannabinoid pharmaceutical product combining low-dose dronabinol (synthetic form of Tetrahydrocannabinol or THC) with acetazolamide (carbonic anhydrase inhibitor). As the company gears up for the critical next phase, it has secured the expertise of two highly regarded lead principal investigators to oversee its Phase 2/3 clinical trial in sleep apnoea.

The two appointed lead principal investigators, Dr John Hudson of FutureSearch Trials of Neurology from Austin, Texas, and Dr Russell Rosenberg of Neurotrials Research in Atlanta, Georgia, are renowned leaders in their field. Their involvement in the trial underscores the effectiveness of IHL-42X demonstrated in the previous phase 2 studies.

Incannex CEO and Managing Director, Joel Latham, expressed his enthusiasm for recruiting these experts, emphasising their crucial role in the Phase 2/3 study. Dr Hudson and Dr Rosenberg’s affiliated facilities will serve as the first clinical trial sites for submission to the US Food and Drug Administration (FDA) and for ethics approval. Incannex plans to establish approximately 45 sites across multiple locations, both in the US and other jurisdictions, for this critical trial.

According to Dr Hudson, obstructive sleep apnoea remains significantly under-treated due to factors such as underdiagnosis and patient non-compliance with existing therapeutic methods. The emergence of oral medications as a potential solution to reduce the causes of OSA represents an exciting and potentially life-changing development for countless patients.

Dr Rosenberg stressed that many sleep apnoea patients struggle with adhering to positive airway pressure therapy or simply refuse it. Having a safe and effective pharmacological option like IHL-42X would be a positive addition to the treatment landscape, providing an alternative therapy for those in need.

Previous Phase 2 trials conducted by Incannex yielded impressive results, with participants experiencing a substantial reduction in the apnoea-hypopnea index (AHI) compared to the placebo group. In the IHL-42X arm, the average AHI was reduced by 50.7%, from 42.8 to 21.1 events per hour. Furthermore, 60% of participants achieved a reduction in AHI greater than 55%, and 25% experienced an 80% or greater reduction.

The progress made by Incannex Healthcare in developing a pharmaceutical solution for sleep apnoea marks an intriguing milestone in the field of respiratory medicine.

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