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Incannex Receives HREC Approval for Phase 2 Clinical Trial Assessing IHL-675A for use in Treatment of Pain and Function in Rheumatoid Arthritis
Highlights: Incannex has received approval from HREC for the lead site, Emeritus Research, Camberwell, VIC for the Phase 2, Blinded, Placebo Controlled
About this update from Incannex Healthcare Inc.
[{"type":"text","content":"Highlights: Incannex has received approval from HREC for the lead site, Emeritus Research, Camberwell, VIC for the Phase 2, Blinded, Placebo Controlled Clinical Trial to Determine the Effect on Pain and Function of IHL-675A in Patients with Rheumatoid Arthritis. The Phase 2 trial follows a successful Phase 1 trial where IHL-675A was observed to be well tolerated and safe.It follows animal study observations of IHL-675A substantially reducing inflammatory disease scores to a greater extent than hydroxychloroquine, a common long-standing prescription drug for rheumatoid arthritis with a considerable market profile.This trial will be managed by Avance Clinical, an Australian and US CRO, who will engage 8-10 clinical trial sites across Australia and New Zealand, recruiting 128 patients in total.The trial will aim to assess the effect of IHL-675A on pain and function by utilising patient reported outcomes, disease scores and inflammatory biomarker analysis over a 24-week period.The results of the trial will establish the efficacy of IHL-675A in rheumatoid arthritis patients and contribute to the combination rule assessment in a 505(b)2 new drug application dossier with FDA. MELBOURNE, Australia, July 13, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’), a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that it has received approval from Bellberry Human Research Ethics Committee (‘HREC’) for the lead site, Emeritus Research, Camberwell, Victoria, for its Phase 2 clinical trial. The trial is pivotal in nature and will assess the efficacy of IHL-675A, its proprietary anti-inflammatory combination drug product, in patients with rheumatoid arthritis (‘RA’). The Phase 2 trial follows the successful Phase 1 clinical trial, results of which were released on 1 May, 2023, whereby both active pharmaceutical ingredients, cannabidiol (‘CBD’) and hydroxychloroquine sulphate (‘HCQ’), were absorbed from the Company’s proprietary fixed dose combination product IHL-675A. The drug product was also 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 R...