Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 63

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 63
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 Effects of IHL-675A on Pain
and Function in Patients with Rheumatoid Arthritis

We planned to conduct a Phase 2 clinical trial
in Australia to assess the safety and efficacy of IHL-675A on pain and function in patients with rheumatoid arthritis. The trial was planned
to include approximately 128 subjects who met the eligibility criteria and who upon enrollment would have been be randomized according
to one of four arms: either IHL-675A, CBD alone, HCQ alone or placebo. The treatments were to be double blinded, meaning neither the investigators
nor patients would have known which treatment an individual was receiving.

The primary endpoint for the Phase 2 trial was
pain and function relative to baseline determined via the score on the RAPID3 assessment at 24 weeks. Per the protocol, participants were
to record their pain and function outcomes daily, by completing questionnaires on pain, fatigue, joint stiffness and quality of life,
using an electronic patient reported outcomes device (similar to completing a questionnaire on an electronic tablet). The participants
also attended monthly visits at the clinical trial site, where blood tests, and physical examinations were to monitor additional safety
and efficacy outcomes, including inflammatory biomarkers. This study was terminated prior to completion due to challenges with patient
recruitment. Insufficient data was collected to make any conclusions on safety or efficacy of IHL-675A.

FDA Development

We have completed pre-IND meetings with the FDA
to discuss the regulatory pathway for the development of IHL-675A for rheumatoid arthritis and inflammatory lung conditions in the United
States and plan to initially open an IND for a Phase 2 trial for rheumatoid arthritis. The FDA provided guidance on the requirements for
505(b)(2) NDA submissions, as was proposed for IHL-675A, that rely on the FDA’s finding of safety and/or effectiveness for listed
drugs. In the pre-IND meeting for use of IHL-675A for treatment of rheumatoid arthritis, the FDA confirmed that no further non-clinical
studies are needed to open an IND and provided guidance on the proposed clinical development plan for IHL-675A in rheumatoid arthritis.
We are currently building on the feedback from FDA to design an IND opening study to investigate the safety and efficacy of IHL-675A
in patients diagnosed with rheumatoid arthritis.

Secondary Assets and Additional Opportunities

While we are focusing our available resources on
the continued development of our