Incannex announces final results from Phase 1 trial assessing IHL-675A

Incannex Healthcare announces that it has received final results from the Phase 1 clinical trial undertaken to assess pharmacokinetics and safety of the anti-inflammatory drug IHL-675A. The Phase 1 trial measured the safety, tolerability, and pharmacokinetic profiles of IHL-675A compared to the reference listed drugs, Epidiolex and Plaquenil. IHL-675A was well tolerated, with no adverse events of concern and no serious adverse events reported. The same number of treatment related treatment emergent adverse events were reported for IHL-675A as for Epidiolex. IHL-675A is well tolerated in healthy volunteers. Adverse events for IHL-675A were consistent with what was observed, and has been publicly reported, for Epidiolex and Plaquenil. The safety and pharmacokinetic data from this Phase 1 clinical trial in healthy volunteers adds to the company’s confidence in proceeding with assessment of IHL-675A in patients with inflammatory diseases. As HCQ is already approved for treatment of rheumatoid arthritis, it is the first indication for which IHL-675A will be assessed in a Phase 2 clinical trial. The primary endpoint for the study is pain and function relative to baseline determined via the score on the RAPID3 assessment at 24 weeks. The trial will be conducted in Australia and will update the ASX and Nasdaq once approval to conduct the trial is received from a human research ethics committee. Trial designs for Phase 2 studies in patients with inflammatory bowel disease and lung inflammation are also being developed. The treatment of these three indications has a combined global annual market size of exceeding US$125B per annum. In addition, Incannex has filed a request for pre-IND meeting on the development of IHL-675A for treatment of arthritis with the FDA. Following the pre-IND meeting, the Company intends to open an IND in parallel with the Australian Phase 2 study, allowing for the conduct of trials in the US if the Australian study continues to support the therapeutic potential of IHL-675A in patients with arthritis.