Set to push on with the most extensive trials yet for its lead drug candidate IHL-42X, Incannex Healthcare is firming up its credentials to deliver a sea change in the treatment of obstructive sleep apnoea (OSA).
OSA’s symptoms are a reduction – or in some cases a complete stopping – of normal airflow in breathing during sleep. The condition presents as snoring, and in severe cases, patients wake up breathless. Immediate effects are deceptively innocent – sleepiness, affecting performance and mood. For drivers and machinery operators the effects can be deadly. Long-term consequences include an increased risk of heart disease and mental health disorders.
With the company’s mission to focus on unmet medical needs, Dr Mark Bleackley, Incannex’s Chief Scientific Officer, says there are few more deserving examples of a condition requiring alternative treatment. Talking to Edison, he said:
‘Estimates suggest OSA affects about a billion people, around 20% of the world’s adult population. It’s on the increase and there are no pharmacotherapies available.’
Key to Incannex’s plan is to disrupt the existing non-pharmacotherapy treatments that are expensive and have poor patient compliance – most often, mechanical devices – continuous positive airway pressure (CPAP) machines, dental alterations and surgery as a fall back. The sleep apnoea device market alone was worth about $3.9 billion in 2021 according to Evolve Business Intelligence.
IHL-42X is in fact two drugs – a cannabinoid combination product – and the result of three years of research under Dr Bleackley’s direction.
‘It’s made up of two pharmaceutical ingredients – acetazolamide, a carbonic anhydrase inhibitor, and dronabinol, a synthetic form of THC. Both have clinical evidence to support their therapeutic effect in OSA,’ said the CSO.
‘Each targets different components of the disease and that was the basis for our hypothesis that the combination would be synergistic.’
Data from the first proof-of-concept trial has confirmed the hypothesis was correct: that IHL-42X reduced the number of ‘apnoeas’ (pauses in breathing), and ‘hypopneas’ (incidents of shallow breathing), but the synergy of the product’s ingredients created an additional win – the foundation of its IP protection.
2023 will see Incannex’s research scale up significantly. Bioavailability and bioequivalence studies will roll out before the company files an IND with the FDA for Phase II/III study, when multiple sites across North America and Europe will see more than 400 patients involved over 12 months.
‘This is about disrupting a multibillion dollar market and gaining value for investors in the short, mid and long-term,’ says Incannex CEO, Joel Latham,’ but it’s also about giving OSA patients a choice.’
‘We want to develop novel therapies to make a difference to the lives of millions of people, giving them a far more convenient and effective treatment.’
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