Incannex Healthcare Limited has received approval from the Bellberry Human Research Ethics Committee (HREC) for its Phase 2 clinical trial. The trial aims to evaluate the effectiveness of IHL-675A, a unique anti-inflammatory combination drug product, in patients suffering from rheumatoid arthritis (RA). This pivotal trial comes after a successful Phase 1 study where IHL-675A demonstrated excellent safety and tolerability. Animal studies have also indicated that IHL-675A is more effective than hydroxychloroquine, a commonly prescribed RA medication, in reducing arthritis symptoms. Avance Clinical will oversee the management of this Phase 2 trial which plans to enroll 128 participants from Australia and New Zealand.
Throughout the course of the 24-week trial, patient-reported outcomes, disease scores, and analysis of inflammatory biomarkers will be utilized to assess the impact of IHL-675A on pain and functionality in individuals with RA. The results obtained from this study will not only determine the efficacy of IHL-675A in treating rheumatoid arthritis but also contribute towards future regulatory applications. Dr. Mark Bleackley, Chief Scientific Officer at Incannex, expressed