Incannex Commences Dosing in Phase 2 Clinical Trial Assessing IHL-675A in Patients with Rheumatoid Arthritis

MELBOURNE, Australia and NEW YORK, Jan. 24, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex’ or the ‘Company’), a pharmaceutical company developing novel medicinal cannabinoid pharmacotherapies and psychedelic medicine therapies for unmet medical needs, is pleased to announce that patient dosing has commenced in the Phase 2 clinical trial assessing IHL-675A in patients with rheumatoid arthritis (RA).

IHL-675A is the Company’s proprietary combination drug candidate composed of Hydroxychloroquine Sulphate (HCQ) and cannabidiol (CBD), both of which have well characterized anti-inflammatory activity when administered individually (1, 2). The primary endpoint of the double-blind, Phase 2 clinical trial is pain and function relative to baseline determined via the score on the RAPID-3 assessment at 24 weeks. The trial will enroll 128 participants across 10 study sites in Australia with participants receiving either IHL-675A, CBD, HCQ or placebo. Participants will 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.

Chief Scientific Officer of Incannex, Dr. Mark Bleackley, said; “Commencing dosing in the Phase 2 clinical trial in patients with RA is an exciting milestone for the development of 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 and other regulatory agencies.”

Participants in the Phase 2 trial 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 trial will also include a sub-study examining joint inflammation and damage via Magnetic Resonance Imaging (MRI). The results of this trial will be a critical component of future regulatory applications, including contributing to the combination rule assessment in the FDA505(b)2 new drug application (NDA) dossier.