Incannex Healthcare Limited 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.
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IHL-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.
CEO 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 we are delighted and excited to take IHL-675A to the clinic for the first time”.
The trial will measure the safety, tolerability, and pharmacokinetic profiles of IHL-675A compared to the reference listed drugs, Epidiolex (CBD) and Plaquenil (HCQ). Three cohorts of 12 participants (n = 36) will receive either IHL-675A, CBD or HCQ and the assessments will be identical across the three arms of the trial.
Chief Scientific Officer of Incannex Healthcare, Dr Mark Bleackley said; “The aims of the trial are to demonstrate that there are no, or minimal, additional side effects associated with the combination of CBD and HCQ compared to each drug alone and that the uptake and metabolism, otherwise known as pharmacokinetics, of the two drugs do not materially interfere with one another”.