Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 53

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 53
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. The proportion
of subjects reporting at least one TEAE on the IHL-42X fasted period (57.4%) was similar to the dronabinol fasted period (52.1%). Fewer
subjects reported TEAEs during the acetazolamide fasted treatment period (37.8%). Food did not have a substantial effect on the number
of subjects reporting TEAEs for IHL-42X, with 57.4% fasted vs 58.8% fed.

5

We expect the outcomes of the BA/BE trial will
serve as a bridging mechanism to the reference listed drugs, potentially facilitating regulatory approval via the FDA 505(b)(2) regulatory
pathway.

Phase 2/3 Clinical Trial Investigating IHL-42X in Patients with
OSA (the “RePOSA Study”)

The RePOSA Study is a  randomized, double-blind
Phase 2/3 clinical trial, investigating the effect of IHL-42X in patients with OSA who are non-compliant, intolerant or naïve to
PAP devices, such as CPAP, to determine the safety and efficacy of the drug candidate. The RePOSA study is being conducted in accordance
with an IND cleared by the FDA.

The primary endpoint of the RePOSA Study is a change
in AHI as compared to baseline. Key secondary endpoints include a change in patient sleep quality, sleep related impairments and fatigue.
Other secondary endpoints include a change in oxygen saturation index, hypoxic burden and sleepiness. Exploratory endpoints are change
in sleep architecture, cognitive function, blood pressure and other biomarkers identified for those at risk for OSA. The Phase 2 portion
of the RePOSA Study was a four-week, dose ranging, three-arm (IHL-42X low dose (2.5 mg dronabinol + 125 mg acetazolamide), IHL-42X high
dose (5 mg dronabinol + 250 mg acetazolamide) and placebo) trial designed to determine the optimal dose of IHL-42X based on safety and
efficacy in OSA patients. The Phase 3 portion of the trial is a 52-week, four-arm (IHL-42X, dronabinol, acetazolamide and placebo), factorial
trial that will compare the optimal dose of IHL-42X to the component APIs, dronabin