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Incannex Healthcare - On to Phase II for IHL-675A

Incannex has reported final results from its Phase I trial assessing the safety and pharmacokinetics (PK) of IHL-675A, a cannabidiol (CBD) and hydroxychloroquine (HCQ) fixed-dose combination drug, for the treatment of rheumatoid arthritis (RA). IHL-675A was generally well-tolerated and showed a comparable adverse event profile to reference drugs Epidiolex and Plaquenil. PK analyses revealed that CBD uptake was faster, and HCQ uptake was slower, for IHL-675A versus reference drugs. This could be advantageous for the combination drug, as CBD provides immediate relief for inflammation and pain in RA patients, and HCQ provides extended relief. In February 2023, Incannex initiated a blinded, placebo-controlled Phase II study for IHL-675A in RA. The company has also filed a pre- Investigational New Drug (IND) request with the FDA, intending to conduct parallel Phase II studies in the US. We view these results as encouraging for the clinical development of IHL-675A, provided data from Phase II studies continue to be supportive.