Incannex Healthcare Limited IXHL IHL has received approval from Bellberry Human Research Ethics Committee (‘HREC’) for the lead site, Emeritus Research, Camberwell, Victoria, for its phase 2 clinical trial. The trial will assess the efficacy of IHL-675A, its proprietary anti-inflammatory combination drug product, in patients with rheumatoid arthritis (‘RA’).
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, CBD and hydroxychloroquine sulphate (‘HCQ’), were absorbed from the company’s proprietary fixed dose combination product IHL-675A.
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 randomized to one of 4 arms: either IHL-675A, CBD alone, HCQ alone or placebo.
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.
Incannex CSO Dr Mark Bleackley stated: “HREC approval for the phase 2 clinical trial is a key step in the development of IHL-675A for treatment of pain and reduced function associated with rheumatoid arthritis. We look forward to working with Emeritus and Avance to assess the effect of IHL-675A in this patient population.”
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