Incannex is looking to replicate results from last year’s Phase-II proof of concept clinical trial of IHL-42X for treatment of obstructive sleep apnoea (OSA) in its upcoming long term multi-site pivotal study.

Incannex Healthcare (ASX:IHL) is approaching with confidence the upcoming pivotal (Phase-2/3) study of its novel cannabinoid combination for patients with obstructive sleep apnoea after promising Phase-II results released last year.

 The Phase-II trial looked at three different doses of IHL-42X at reducing the apnoea hypopnoea index (AHI), which is the diagnostic and monitoring criteria for OSA.

Results found that IHL-42X reduced AHI by an average of 50.7% versus baseline assessments and 25% of participants experienced greater than an 80% reduction in AHI measure.

No serious treatment emergent adverse events were reported during the clinical trial.

Furthermore, THC concentrations in blood were below the limits for impaired driving the morning after nocturnal dose administration of IHL-42X.

IHL has filed a patent application over IHL-42X, which has been deemed “novel and inventive” by the international patent examiner.

Key recruitment complete

IHL is a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs.

IHL recently announced it had recruited two highly experienced lead principal investigators (PIs) for the investigational new drug (IND) opening Phase-2/3 clinical trial into IHL-42X for OSA.

Recruitment of Dr John D Hudson of FutureSearch Trials of Neurology, Austin, Texas and Dr Russell Rosenberg of Neurotrials Research Inc, Atlanta, Georgia is a critical step for the IND opening Phase-2/3 study.

Hudson and Rosenberg, and their associated facilities, will serve as the first clinical trial sites for submission to the US FDA and for ethics approval from Institutional Review Boards.

IHL said site recruitment and selection in the US and other jurisdictions is an iterative process with the company planning to recruit ~45 sites across multiple jurisdictions for the pivotal trial.

Sleep apnoea under treated

Hudson said clinical trials for novel formulations of medication are newsworthy for any specialty and sleep medicine is no exception.

“Obstructive Sleep Apnea, affecting millions of people, remains under treated,” he said.

Hudson said the under treatment of OSA is due in part to patients not being diagnosed, and in part due to poor patient compliance with current therapeutic modalities.

“While unheard of a few years ago, oral medications to help reduce the cause of OSA, are now undergoing further investigation,” he said.

“This is more than exciting, it could prove to be life-changing for many patients.”

Rosenberg said IHL has developed a sound, rational, scientific protocol to determine the efficacy and safety of IHL-42X in patients with OSA.

“Many sleep apnoea patients cannot adhere to positive airway pressure therapy, use it for an inadequate period at night or just refuse it,” he said.

Hudson said having a safe, effective pharmacological option for obstructive sleep apnoea will be a positive addition to the treatment landscape.

Approaching latest trial with confidence

IHL CEO and managing director Joel Latham said the team is approaching the upcoming long term multi-site pivotal study with confidence.

“We have de-risked our novel and proprietary treatment, optimised dosing and are very confident in the study design to ensure patient and regulatory success,” he said.

Latham said trial participants will be dosed over a period of 52 weeks with interim results announced when 50% of patients complete their month 3 PSG testing with a full clinical study report to follow completion of patient dosing.

He said there are around 600 million people globally suffering from OSA, with no registered pharmaceutical treatment options currently available, the company is rigorously working towards being the first to have a registered treatment for OSA. If successful, granting Incannex regulatory marketing exclusivity.

The addressable OSA market was valued at US$8 billion in 2021 and forecast to rise to US$13 billion by 2028.

If results from the Phase-II proof of concept clinical trial are replicated in the upcoming trial then IHL is banking on having a very marketable and de-risked product close to market launch.

Meanwhile, IHL’s psychedelics focused subsidiary Psychennex, which is pioneering the Australian psychedelics sector via its clinical research programs and service delivery through its Clarion Clinics Group, is gearing up to open its first clinic in Melbourne in Q3 CY23.

IHL’s is moving to take advantage of a landmark decision by the Therapeutic Goods Administration (TGA) which is now just days away.

From July 1, medicines containing the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) can be prescribed by authorised psychiatrists in Australia for treating depression and PTSD.

This article was developed in collaboration with Incannex Healthcare ,a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.