Incannex’s IHL-42X is intended for the treatment of obstructive sleep apnoea. Credit: sbw18 / Shutterstock.

The US Food and Drug Administration (FDA) has granted clearance to Incannex Healthcare’s investigational new drug (IND) application enabling the initiation of a Phase II/III study of IHL-42X for the treatment of obstructive sleep apnoea.

The FDA granted the approval after completing its review of the substantial application submitted to the authority on 20 July.

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Incannex’s pivotal trial will evaluate the effect of IHL-42X in obstructive sleep apnoea patients who are intolerant, non-compliant, or naive to positive airway pressure treatment, administered via CPAP devices.

Patients will receive one dose of IHL-42X, dronabinol, acetazolamide or placebo.

They will complete daily surveys on their sleep quality and attend the clinic monthly for their sleep and cognitive function assessments and other safety and efficacy measures.

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A polysomnography will also be conducted overnight in patients every three months to determine the effect of treatment on the Apnoea-Hypopnea Index (AHI) along with various other sleep parameters.

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IHL-42X is a combination of dronabinol, a synthetic form of tetrahydrocannabinol (THC), and acetazolamide, a carbonic anhydrase inhibitor.

In earlier Phase II proof of concept study, IHL-42X was found to reduce AHI by an average of 50.7% versus baseline assessments.

The concentrations of THC in blood were also observed to be below the limits for impaired driving the morning after nocturnal IHL-42X dose administration.

Furthermore, no serious treatment-emergent adverse events were reported during the study.