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Incannex Healthcare | 8-K: Current report

SEC announcement ·  Jan 25 05:35
Summary by Futu AI
On January 24, 2024, Incannex Healthcare Inc., a pharmaceutical company, announced the initiation of patient dosing in a Phase 2 clinical trial for its drug candidate IHL-675A, aimed at treating rheumatoid arthritis (RA). The trial will evaluate the safety and efficacy of IHL-675A, a proprietary combination of Hydroxychloroquine Sulphate (HCQ) and cannabidiol (CBD), both known for their anti-inflammatory properties. The double-blind study will enroll 128 participants across 10 Australian sites, with the primary endpoint being pain and function relative to baseline at 24 weeks. The trial includes daily patient-reported outcomes and a sub-study using MRI to examine joint inflammation and damage. The results are expected to contribute to future regulatory applications, including the FDA505(b)2 new drug application. Incannex Healthcare has a robust intellectual property position over IHL-675A, which is also being considered for other inflammatory conditions. The announcement follows the successful completion of a Phase 1 trial that demonstrated the tolerability and favorable pharmacokinetics of IHL-675A.
On January 24, 2024, Incannex Healthcare Inc., a pharmaceutical company, announced the initiation of patient dosing in a Phase 2 clinical trial for its drug candidate IHL-675A, aimed at treating rheumatoid arthritis (RA). The trial will evaluate the safety and efficacy of IHL-675A, a proprietary combination of Hydroxychloroquine Sulphate (HCQ) and cannabidiol (CBD), both known for their anti-inflammatory properties. The double-blind study will enroll 128 participants across 10 Australian sites, with the primary endpoint being pain and function relative to baseline at 24 weeks. The trial includes daily patient-reported outcomes and a sub-study using MRI to examine joint inflammation and damage. The results are expected to contribute to future regulatory applications, including the FDA505(b)2 new drug application. Incannex Healthcare has a robust intellectual property position over IHL-675A, which is also being considered for other inflammatory conditions. The announcement follows the successful completion of a Phase 1 trial that demonstrated the tolerability and favorable pharmacokinetics of IHL-675A.
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