Incannex Healthcare (ASX:IHL) has received approval from Bellberry Human Research Ethics Committee (‘HREC’) for the lead site, Emeritus Research in Victoria, for its Phase 2 clinical trial.
The trial will assess the safety and efficacy of IHL-675A, the company's proprietary anti-inflammatory combination drug product, in patients with rheumatoid arthritis (RA).
The company said the Phase 2 trial follows the successful Phase 1 clinical trial, which demonstrated that both active pharmaceutical ingredients, cannabidiol (CBD) and hydroxychloroquine sulphate (HCQ), were absorbed from its proprietary fixed-dose combination product IHL675A.
It said the drug product was also tolerated well, with no adverse events of concern.
The Phase 2 study will assess the efficacy, safety and tolerability of IHL-675A compared to the respective component Active Pharmaceutical Ingredients (APIs), CBD and HCQ, and placebo.
It will include 128 participants who meet the eligibility criteria and is designed to include patients who have ongoing pain and reduced function while on stable treatment for their RA.
The primary endpoint 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.
Incannex chief scientific officer Dr Mark Bleackley said, “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 IHL675A in this patient population.”