Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 46

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 46
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erved that the combination of synthetic psilocybin with psychotherapy significantly reduced anxiety scores and was well-tolerated in
GAD patients. In this trial, statistically meaningful reductions in Hamilton Anxiety Rating Scores (“HAM-A scores”) were observed,
with subjects in the investigational arm achieving an average 12.8-point reduction from baseline that was sustained for an 11-week follow
up period. A greater than 50% reduction in HAM-A scores was observed in 44.1% of subjects receiving the experimental treatment and 24%
of subjects in the treatment arm achieved full disease remission, a number five times higher than placebo. Improvements were also observed
in secondary endpoint measures. PSX-001 was observed to be well-tolerated with no serious adverse events reported. The majority of TEAEs
were transient, mild to moderate in nature and consistent with the expected pharmacological effects of psilocybin. No signs of increased
suicidality, psychosis, or prolonged psychological distress, concerns often cited with psychedelic treatments, were observed. We have
a cleared Investigational New Drug (“IND”) application with the FDA and are preparing to initiate a multi-jurisdiction Phase
2 clinical trial in 2026.

IHL-675A is our drug candidate for the treatment
of inflammatory conditions, with an initial focus on rheumatoid arthritis. IHL-675A is an oral fixed-dose combination of cannabidiol (“CBD”)
and hydroxychloroquine sulfate designed to target two different pathways, acting synergistically to alleviate inflammation. In our Phase
1 clinical trial, IHL-675A was observed to be well-tolerated and bioavailable. In preclinical studies, IHL-675A was observed to reduce
inflammatory markers and disease scores across multiple animal inflammatory disease models and in vitro assays. This candidate was being
developed in an Australian Phase 2 trial investigating the safety and efficacy of IHL-675A in rheumatoid arthritis patients, but we encountered
patient recruitment challenges and this Phase 2 clinical trial was terminated. Insufficient data was collected to make any conclusions
on safety or efficacy of IHL-675A. We now are developing a strategy for an IND opening study investigating the safety and efficacy of
IHL-675A in patients diagnosed with rheumatoid arthritis to be conducted in the United States.

Each of these programs represents a potential new
approach to treating serious conditions that currently have limited, inadequate, or no approved