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Incannex Receives Ethics Approval to Commence Phase 1 Clinical Trial of Multi-Use Anti-Inflammatory Drug IHL-675A
Highlights: Bellberry human research ethics committee approved the phase 1 clinical trial investigating safety and pharmacokinetics of IHL-675A on July 20,
About this update from Incannex Healthcare Inc.
[{"type":"text","content":"Highlights:\nBellberry human research ethics committee approved the phase 1 clinical trial investigating safety and pharmacokinetics of IHL-675A on July 20, 2022The trial will be performed at CMAX Clinical Research, a dedicated and experienced clinical trial centre in Australia, and managed by Avance ClinicalThe trial will assess the pharmacokinetics, safety, and tolerability of combination cannabinoid drug IHL-675ATrial data will be applicable to regulatory submissions for all three IHL-675A development programs, rheumatoid arthritis, inflammatory bowel disease and lung inflammationFormulation and manufacturing of IHL-675A soft gel capsules for the clinical trial has been completed; long term stability studies are ongoingPatient recruitment is scheduled to commence in August 2022MELBOURNE, Australia, July 21, 2022 /PRNewswire/ -- 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 the Bellberry Human Research Ethics Committee ('HREC') for a phase 1 clinical trial investigating its proprietary multi-use, anti-inflammatory drug IHL-675A.\nIHL-675A is a combination cannabinoid drug comprising cannabidiol ('CBD') and hydroxychloroquine ('HCQ') in a fixed dose combination. IHL-675A was observed to outperform either CBD and HCQ in various pre-clinical models of inflammation, including in vivo models of rheumatoid arthritis, inflammatory bowel disease and lung inflammation. Synergistic anti-inflammatory activity of CBD and HCQ was observed in these distinct pre-clinical studies and was evidence to support the Company's international patent application over the drug.\nCEO and Managing Director, Mr Joel Latham said; \"Approval to begin our Australian phase 1 trial is a significant milestone for Incannex and clinicians treating patients with disorders for which inflammation is the underlying cause. There's a growing trend whereby patients are using CBD to treat, or supplement their existing treatments, for inflammation disorders. We have observed in established models of inflammation that IHL-675A is a stronger anti-inflammatory cannabinoid-based drug than CBD administered alone, hence w...