Incannex receives HREC approval for Phase 2 trial of IHL-675A

Incannex Healthcare announced that it has received approval from Bellberry Human Research Ethics Committee for the lead site, Emeritus Research, Camberwell, Victoria, for its Phase 2 clinical trial. The trial is pivotal in nature and will assess the efficacy of IHL-675A, its proprietary anti-inflammatory combination drug product, in patients with rheumatoid arthritis. The Phase 2 trial follows the successful Phase 1 clinical trial, results of which were released on 1 May, 2023, whereby both active pharmaceutical ingredients, cannabidiol and hydroxychloroquine sulphate, were absorbed from the Company’s proprietary fixed dose combination product IHL-675A. The drug product was also observed to be well tolerated, with no adverse events of concern. Prior to commencing clinical trials, Incannex observed positive results from an animal model of RA. IHL-675A was observed to be more effective at reducing arthritis across multiple assessments including clinical score, paw volume, pannus score, total histology score and serum cytokine levels than the rodent equivalent of the standard dose of HCQ or equivalent doses of CBD. The reduction in disease assessments achieved by IHL-675A was 1.06-3.52 times that observed for HCQ alone at the standard dose. These promising observations led the company to prioritise rapid clinical assessment, particularly given that HCQ, marketed as Plaquenil and generic equivalents, is a common long-standing treatment prescribed for RA with a considerable market profile. The Phase 2 study, that has now been approved by HREC at the lead site Emeritus Research, Camberwell, Victoria, will assess the efficacy, safety and tolerability of IHL-675A compared to the respective component Active Pharmaceutical Ingredients, CBD and HCQ, and placebo. The treatments will be double blinded, meaning neither the investigators nor patients will know which treatment an individual is receiving. The study will be managed by Avance Clinical, an Australian and US CRO. Recruitment of additional sites with experience in rheumatology clinical trials is ongoing, with the goal of 8-10 sites across Australia and New Zealand being included in the study. The trial will include 128 participants who meet the eligibility criteria and is designed to include patients who have on-going pain and reduced function while on stable treatment for their RA. Participants will be randomised to one of 4 arms: either IHL-675A, CBD alone, HCQ alone or placebo. The primary endpoint for the study is pain and function relative to baseline determined via the score on the RAPID3 assessment at 24 weeks. Participants will also record their pain and function outcomes daily, by completing questionnaires on pain, fatigue, joint stiffness, and quality of life, using an electronic Patient Reported Outcomes device. The participants will attend monthly visits at the clinical trial site, where blood tests, and physical examinations will monitor additional safety and efficacy outcomes including inflammatory biomarkers. The trial will also include a sub-study examining joint damage via MRI. Subjects will be assessed for eligibility in the MRI study based on their Rheumatoid Arthritis Magnetic Resonance Imaging Score at screening. The results of the trial will establish the efficacy of IHL-675A in RA and will be a critical component of future regulatory applications, including contributing to the combination rule assessment in the FDA505(b)2 new drug application dossier.