Incannex Healthcare has initiated subject dosing in a Phase II clinical trial to evaluate the drug candidate IHL-675A in treating rheumatoid arthritis (RA).
A combination drug, IHL-675A integrates hydroxychloroquine sulphate (HCQ) and cannabidiol (CBD).
The double-blind trial aims to assess pain and function variations from baseline using the RAPID-3 score at 24 weeks as its primary endpoint.
It will involve 128 subjects from across ten Australian trial sites.
Trial subjects will be given either IHL-675A, CBD, HCQ or a placebo.
The pain and function outcomes will be recorded daily by the trial subjects using an electronic Patient Reported Outcomes device. For this, the participants will complete questionnaires on pain, fatigue, joint stiffness and quality of life.
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Furthermore, monthly clinical visits will include blood sample tests and physical exams to monitor efficacy and safety, focusing on inflammatory biomarkers.
Additionally, the trial will have a sub-study to evaluate joint inflammation and damage through magnetic resonance imaging.
The trial outcomes are expected to be pivotal for regulatory submissions in the future, including the FDA505(b)(2) new drug application process.
Prior to this, Incannex conducted a Phase I trial in 2022 and 2023 to determine the safety, tolerability and pharmacokinetics of IHL-675A.
The trial compared IHL-675A against reference drugs Epidiolex and Plaquenil, with 36 participants across three cohorts.
Throughout the 28-day monitoring period, IHL-675A was demonstrated to be well tolerated without any serious adverse events.
Incannex chief scientific officer Dr Mark Bleackley said: “Commencing dosing in the Phase II clinical trial in patients with RA is an exciting milestone for developing IHL-675A.
“Millions of people are affected by pain associated with rheumatoid arthritis despite the available treatment options. IHL-675A has the potential to address this unmet need.
“We look forward to generating data on the safety and efficacy of IHL-675A and sharing this data with FDA [Food and Drug Administration] and other regulatory agencies.”