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Incannex Commences Phase 2 Clinical Trial Assessing IHL-675A for use in Treatment of Pain and Function in Rheumatoid Arthritis
Highlights: Incannex has commenced a Phase 2, Blinded, Placebo Controlled Clinical Trial to Determine the Safety and Effect on Pain and Function of IHL-675A
About this update from Incannex Healthcare Inc.
[{"type":"text","content":"Highlights: Incannex has commenced a Phase 2, Blinded, Placebo Controlled Clinical Trial to Determine the Safety and 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 animal studies whereby IHL-675A was observed to reduce inflammatory disease scores to a greater extent than hydroxychloroquine, a common long standing prescription drug for rheumatoid arthritis.The trial will be managed by Avance Clinical, an Australian and US contract research organisation, who will engage 8-10 clinical trial sites across Australia and New Zealand, recruiting 120 patients in total.The trial will 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. There will be an option for trial participants to participate in an extension study following the trial.Patients, who meet the criteria for joint damage, may also be included in an magnetic resonance imaging assessment sub-study.The results of the trial will establish the safety and efficacy of IHL-675A and contribute to the combination rule assessment in a FDA505(b)2 new drug application dossier. SYDNEY, Australia, Feb. 28, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a pharmaceutical company developing proprietary medicinal cannabinoid products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that it 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 cannabidiol (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. IHL-675A was observed to be more effective than a standard dose of HCQ at reducing arthritis across multiple assessments including; clinical score, paw volume, pannus score, total histology score and serum cytokine le...