Incannex Commences Phase 2 Clinical Trial Assessing IHL-675A for use in Treatment of Pain and Function in Rheumatoid Arthritis

Last week, Incannex Healthcare (IHL), a biotech company at the forefront of developing novel medicinal cannabinoid compounds and psychedelic therapies, announced the commencement of a phase 2 clinical trial of IHL-675A. IHL-675A is a unique and synergistic combination of cannabidiol (CBD) and hydroxychloroquine sulphate (HCQ) targeted at treating inflammatory diseases, including rheumatoid arthritis. This trial, which is a significant milestone for Incannex, will assess the safety and efficacy of IHL-675A in patients with rheumatoid arthritis. It follows on from the successful completion of the Phase 1 trial, where IHL-675A was well tolerated in participants with no adverse effects. In total there will be 120 patients involved in the trial to be conducted in Australia and New Zealand. There will be four arms, where the efficacy and safety of IHL-675A will be compared to the respective component of Active Pharmaceutical Ingredients (APIs), CBD and HCQ, and placebo. The trial will be double blinded meaning neither the investigators nor the trial participants will know which treatment an individual is receiving.

Rheumatoid Arthritis. Rheumatoid arthritis is an autoimmune and chronic inflammatory disease where the body’s immune system attacks healthy joint tissues leading to pain, swelling and joint stiffness. The inflammation associated with rheumatoid arthritis can also damage other parts of the body. While rheumatoid arthritis currently has no cure, numerous drugs on the market can be used for treatment, such as nonsteroidal anti-inflammatory drugs, corticosteroids and HCQ. This trial aims to prove that IHL-675A has a more potent and broader spectrum anti-inflammatory activity than currently available therapies. This is because IHL-675A combines CBD and HCQ to target the inflammatory pathways involved in the production of key inflammatory cytokines via two different mechanisms in the same drug.

The Rheumatoid Arthritis Market. The global rheumatoid arthritis drugs market is expected to exceed US$70 billion by 2030[1]. The growing prevalence of rheumatoid arthritis is one of the significant drivers of market growth, with an estimated 0.24% to 1.00% of people affected by the condition globally[2]. Growing patient knowledge around rheumatoid arthritis is another critical factor driving market expansion.

IHL-675A’s Regulatory Roadmap. IHL has completed a pre-IND meeting with the FDA to discuss the regulatory pathway for the development of IHL-675A in the United States and plans to open INDs for each of the three indications, rheumatoid arthritis, inflammatory lung conditions (acute respiratory distress syndrome, chronic obstructive pulmonary disease(COPD), asthma and bronchitis) and inflammatory bowel disease. The results of the newly commenced Phase 2 study will be of critical importance to the success of future regulatory applications, including contributing to the combination rule assessment in the FDA505(b)2 new drug application (NDA) dossier.

The initiation of this Phase 2 clinical trial brings IHL one step closer to commercializing IHL-675A and subsequently tapping into the growing rheumatoid arthritis drugs market. Success in this trial could lead to fast tracking of the other commercialization opportunities for IHL-675A mentioned above.


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