Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 52

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 52
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 to the low (2.5 mg dronabinol plus 125 mg acetazolamide) dose
and placebo treatment periods.

Low dose IHL-42X had a similar proportion of subjects
reporting TEAEs and a lower number of total TEAEs than the placebo. This indicated that low-dose IHL-42X was well-tolerated.

This Phase 2 clinical trial both supported our
FDA IND submission and informed the design of the ongoing Phase 2/3 clinical trial (or the RePOSA Study, as discussed below).

Formulation Development and Manufacturing of IHL-42X

We engaged Procaps Group, S.A. (“Procaps”)
for the manufacture of a specific oral fixed-dose formulation of IHL-42X for our clinical trials.

Bioavailability/Bioequivalence Clinical Trial

We conducted a bioequivalence/bioavailability (“BA/BE”)
clinical trial for IHL-42X. The BA/BE study focused on assessing the pharmacokinetics (“PK”) and tolerability of IHL-42X’s
active pharmaceutical ingredients (“APIs”), dronabinol (a synthetic form of THC) and acetazolamide, in comparison to FDA reference
listed drugs Marinol (dronabinol) and acetazolamide oral tablets manufactured by Taro Pharmaceutical Industries. The trial also investigated
the effect of food on IHL-42X tolerability and PK. The BA/BE study was designed to evaluate the concentrations of APIs and metabolites
in blood samples over 48 hours, and to adhere to FDA recommendations for bioequivalence studies. In January 2025, we announced positive
topline results from this trial. These topline results confirmed bioavailability of IHL-42X, demonstrating delivery of both dronabinol
and acetazolamide. The PK profile of IHL-42X was similar to those observed for the respective reference listed drugs, including equivalent
total exposure levels (“AUCinf”) observed for the drug molecules. Furthermore, administration of IHL-42X with food, in contrast
to fasted conditions, indicated no substantial food effect on overall exposure to acetazolamide. Consistent with what is known for the
reference listed drugs, an increase in overall exposure to THC was observed when IHL-42X was administered with food compared to fasted
state. No serious adverse events were reported during the trial. TEAEs were generally observed to be mild to moderate