Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 51

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 51
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 in AHI relative to baseline, and the secondary endpoints included change in oxygen desaturation index (“ODI”),
daytime somnolence measured by the Epworth Sleepiness Scale (“ESS”), improvement in mood as measured by the Profile of Moods
State (“POMS”), and well-being as measured by the Short Form 36. Safety of the IHL-42X combination was assessed through adverse
event monitoring. Participants completed a single-blind placebo treatment period followed by three double-blind IHL-42X treatment periods,
each with a different dose strength of IHL-42X. Each treatment period was seven days with an overnight sleep study on night seven to determine
AHI and other secondary endpoint data. Blood samples were collected the morning after the sleep study and analyzed for THC content.

In the final analysis of data from this
trial, IHL-42X was observed to reduce AHI at all three dose strengths (2.5 mg dronabinol + 125 mg acetazolamide, 5 mg dronabinol +
250 mg acetazolamide, and 10 mg dronabinol + 500 mg acetazolamide). The lowest dose (2.5 mg dronabinol + 125 mg acetazolamide ) was
observed to be the most effective, reducing AHI by an average of 50.7 % relative to baseline, with 25% of subjects’ AHI
reduced by >80%. With low-dose IHL-42X, THC was cleared below the common threshold for impaired driving (1 ng/mL) by the morning
after dosing. Subjects also reported improved sleep quality during IHL-42X treatment periods compared to placebo.

IHL-42X was observed to be generally well-tolerated
with no serious adverse events observed at any dosage level. Adverse events were recorded from the time the subjects enrolled in the trial
until their end-of-study visit. After recording TEAEs, the study team, including investigators and medical monitors, reviewed the TEAEs
to determine whether they were likely related to the drug candidate. Of the 11 subjects studied, TEAEs deemed to be possibly, probably,
or related to study treatment occurred at a higher incidence at the higher doses on dronabinol/acetazolamide (5 mg dronabinol plus 250
mg acetazolamide and 10 mg dronabinol plus 500 mg acetazolamide) compared