Incannex Completes Dosing in Phase 1 Clinical Trial to Assess Multi-Use, Anti-Inflammatory Drug IHL-675A; Proceeds to Phase 2 Clinical Trials

Incannex has today announced the completion of dosing of trial participants in a phase 1 clinical trial for arthritis using its anti-inflammatory drug IHL-675A. The new drug is a combination of cannabidiol (CBD) and hydroxychloroquine (HCQ) in a fixed dose. HCQ is already approved as a treatment for arthritis under the marketing name Plaquenil. In a number of pre-clinical studies IHL-675A outperformed both CBD and HCQ in various inflammation models including in vivo (in living animals [mice]) models of rheumatoid arthritis, inflammatory bowel disease and lung inflammation.

Significantly, no adverse events of concern have been reported from the trial to date and the drug appears to be well tolerated. Participants will continue to be monitored until the end of October after which blood tests taken during the trial will be analysed.

Incannex Chief Scientific Officer, Dr Mark Bleackley said: “It is an exciting milestone for us to complete dosing in our Phase 1 study on IHL-675A because it has so many potential therapeutic uses. At this stage, there have been no unexpected adverse events and the drug appears to be well tolerated. This gives our team the confidence to take the next steps necessary to commence Phase 2 clinical trials, initially in patients with arthritis, then in patients with lung inflammation and inflammatory bowel disease”.

Given the absence of adverse events, Incannex now plans to arrange Phase 2 studies, initially in patients with rheumatoid arthritis. The study involving 100 participants will be conducted in Australia. The company will also organise a pre-IND meeting with FDA on the development of IHL-675A for the treatment of patients with arthritis. 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, provided the Australian study continues to support the therapeutic potential of IHL-675A in patients with arthritis. An improvement to patient outcomes over existing treatments using IHL-675A would potentially open a major market opportunity for Incannex in the treatment of arthritis as well as other inflammatory diseases including lung inflammation and inflammatory bowel disease. The treatment of these three indications has a combined global annual market size exceeding US$125B per annum.

Incannex CEO and Managing Director, Mr Joel Latham said: “Many people throughout the world are using unapproved CBD or cannabinoids for inflammation-based disorders. By undertaking pivotal clinical studies over IHL-675A, and subject to ongoing clinical success, we intend to both disrupt the market for CBD and to open our product to the purview of medical professionals who are eminently more comfortable prescribing FDA approved, pharmaceutical grade products to their patients”.

The full report from the phase 1 trial is due in Q1, 2023.