Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL) is preparing to advance its clinical trial assessing the treatment of rheumatoid arthritis to the second phase, having received approval from the Human Research Ethics Committees (HREC) for the lead site, Emeritus Research, in Camberwell, Victoria.
Proven to be well tolerated in the first phase of trials, IHL-675A is targeted at the management of pain and the improvement of function in those with rheumatoid arthritis.
Phase 2 of the blinded, placebo-controlled trial will be managed by Avance Clinical, an Australian and US contract research organisation (CRO), which will engage 8-10 clinical trial sites across Australia and New Zealand, recruiting 128 patients.
Key step in development
“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,” Incannex Healthcare chief scientific officer Dr Mark Bleackley said.
“We look forward to working with Emeritus and Avance to assess the effect of IHL675A in this patient population.”
Animal studies of IHL-675A demonstrated the ability to substantially reduce inflammatory disease scores, even to a greater extent than hydroxychloroquine, a common long-standing prescription drug for rheumatoid arthritis with a considerable market profile.
The trial is designed to assess the effect of IHL-675A on pain and function using patient-reported outcomes, disease scores and inflammatory biomarker analysis over a 24-week period.
The results will establish the safety and efficacy of IHL-675A in rheumatoid arthritis patients and contribute to the combination rule assessment in a 505(b)2 new drug application dossier with FDA.