Incannex receives ethics approval to start Phase 2 clinical trial for combination drug for rheumatoid arthritis
Health & Biotech
Health & Biotech
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Incannex has been given the green light to start its Phase 2 clinical trial to assess the safety and efficacy of IHL-675A, a combination drug that combines a specific proprietary formulation of CBD and another long standing prescription drug for rheumatoid arthritis.
Biotech Incannex Healthcare (ASX:IHL) has received approval from Bellberry Human Research Ethics Committee (HREC) for the lead site Emeritus Research in Melbourne for its Phase 2 clinical trial.
The Phase 2 trial follows the successful Phase 1 clinical trial whereby both active pharmaceutical ingredients, cannabidiol (CBD) and hydroxychloroquine sulphate (HCQ) were absorbed from IHL’s fixed dose combination product IHL-675A.The drug product was also observed to be well tolerated, with no adverse events of concern.
Before starting clinical trials, IHL observed positive results from an animal model of rheumatoid arthritis.
IHL-675A was observed to be more effective at reducing rheumatoid arthritis across multiple disease 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.
The promising observations led IHL to prioritise rapid clinical assessment, particularly given that HCQ, marketed as “Plaquenil” and generic equivalents, is a common long-standing treatment prescribed for rheumatoid arthritis with a considerable market profile.
The Phase 2 trial will assess the efficacy, safety and tolerability of IHL-675A compared to the respective component active pharmaceutical ingredients (APIs), 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 contract research organisation (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 have 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 rheumatoid arthritis.
Participants will be randomised to one of four arms including 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.
Participants will also record their pain and function outcomes daily, by completing questionnaires on pain, fatigue, joint stiffness, and quality of life.
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 results of the trial will be a critical component of future regulatory applications, including contributing to the combination rule assessment in the US FDA’s new drug application dossier.
“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,” IHL chief scientific officer Dr Mark Bleackley said.
“We look forward to working with Emeritus and Avance to assess the effect of IHL-
675A in this patient population.”
This article was developed in collaboration with Incannex Healthcare, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.