Incannex Starts Phase 2 Clinical Trial Of CBD-Based Drug For Use In Treatment Of Rheumatoid Arthritis

Incannex Healthcare Limited IXHL IHL has commenced a phase 2 clinical trial to assess the safety and efficacy of its proprietary anti-inflammatory combination drug IHL-675A in patients with rheumatoid arthritis (‘RA’). IHL-675A is a proprietary fixed dose combination drug comprising CBD and hydroxychloroquine (‘HCQ’).

This phase 2 clinical trial follows the successful phase 1 clinical trial whereby IHL-675A was observed to be well tolerated, with no adverse events of concern. Prior to commencing clinical trials, Incannex observed positive results from an animal model of RA. The reduction in disease assessments achieved by IHL-675A were 1.06-3.52 times that observed for HCQ alone at the standard dose.

The phase 2 trial now commenced 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 trial will be managed by Avance Clinical, an Australian and US CRO, who will identify and onboard 8-10 clinical trial sites with expertise in RA to conduct patient recruitment and assessments.

The phase 2 trial will include 120 participants who meet the eligibility criteria. Participants will be randomized to one of four arms: either IHL-675A, CBD alone, HCQ alone or placebo. The primary endpoint of the trial 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.

The results of this study will establish the safety and efficacy of IHL-675A in rheumatoid arthritis 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.

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