Incannex Update on IHL-42X Drug Candidate in Phase 2/3 Clinical Trial in Obstructive Sleep Apnea

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MELBOURNE, Australia and NEW YORK, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex’ or the ‘Company’), a pharmaceutical company developing unique medicinal cannabinoid pharmacotherapies and psychedelic medicine therapies for unmet medical needs, is pleased to provide the following update on its proprietary IHL-42X drug candidate.

Obstructive sleep apnea (OSA) is characterised by a narrowing or obstruction of the upper airway during sleep, which interrupts breathing resulting in decreased oxygen uptake and poor sleep quality. This relatively common and chronic disorder is largely undiagnosed and untreated yet can result in a wide range of serious long-term outcomes, including cardiovascular disease (1), cognitive impairments such as memory loss, poor concentration, and judgment (2), depression (3) and death or injury due to traffic accidents resulting from excessive daytime sleepiness (4). The costs associated with OSA are substantial, relating to lost productivity, and workplace and motor vehicle accidents (5). A literature-based analysis of 17 studies across 16 countries estimated that OSA affects some 936 million adults aged 30-69 worldwide, with 425 million having moderate to severe disease (6, 7).

There are no approved pharmacotherapies for treatment of OSA. The best treatment option currently available is positive airway pressure (PAP) which pneumatically splints the airway open to prevent disruptions in breathing. However, PAP devices are not well tolerated by many patients due to discomfort, claustrophobia and the noise of the machine.

Incannex has designed IHL-42X, a combination of dronabinol (synthetic THC) and acetazolamide, for treatment of OSA. Both dronabinol and acetazolamide are clinically proven to reduce apnea hypopnea index (AHI), the measure used for diagnosis and monitoring of OSA (8, 9). However, both drugs have limited efficacy, as well as unwanted side effects at efficacious doses. Dronabinol and acetazolamide affect OSA through different pathways. Binding of dronabinol to cannabinoid receptors, modulates signalling and activates muscles that dilate the airway, preventing collapse and obstruction, whereas acetazolamide induces metabolic acidosis which signals to the body that there is excess CO2 in the blood, inducing the taking of a breath (9, 10).

IHL-42X is designed to combine these two activities, leading to increase in efficacy that reduces AHI to a greater degree and/or facilitating a reduction in dose of each active pharmaceutical ingredient to minimize the side effects. A video presentation of IHL-42X for the treatment of OSA has been uploaded to the Incannex website, link here: https://www.incannex.com/clinical-trail/ihl-42x-osa/.

Results from IHL-42X proof-of-concept Phase 2 clinical trial

To demonstrate proof-of-concept for IHL-42X in the treatment of OSA, Incannex conducted a phase 2 clinical trial comparing three dose strengths of IHL-42X, low dose (2.5 mg dronabinol + 125 mg acetazolamide), medium dose (5 mg dronabinol + 250 mg acetazolamide) and high dose (10 mg dronabinol + 500 mg acetazolamide), to placebo with regards to safety and efficacy in OSA patients.

The trial was a four-period cross over study whereby every patient received each dose of IHL-42X and placebo for 7 days. The seven-day treatment periods were separated by 7-day washout periods to minimize any lasting effect of the treatment. On night seven of each treatment period, patients completed an overnight sleep study with polysomnography (PSG) to assess AHI and other sleep parameters. The results of the sleep studies were compared to baseline values, captured prior to the start of treatment. Change in AHI relative to baseline was the primary endpoint for the study.

The results of the proof-of-concept study confirmed the hypothesis that the combination of dronabinol and acetazolamide is effective at treating OSA. The average reduction in AHI compared to baseline for all three doses of IHL-42X, low (50.7 %), medium (48.1 %) and high (35.2 %), reduced AHI to a substantially greater magnitude than placebo (6.4 %).

When the difference in AHI relative to baseline was compared within each patient for the IHL-42X and placebo treatment periods the low dose was again most effective. The difference for all three doses compared to placebo was statistically significant (p

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