Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), 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.
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".
The trial will be conducted at CMAX Clinical Research in Adelaide, South Australia, and managed by Avance Clinical.
Patient recruitment is anticipated to commence in August 2022.
IHL-675A comprises a combination of HCQ and CBD. HCQ is a disease modifying anti-rheumatic drug that regulates the activity of the immune system, which may be overactive in some conditions. HCQ can modify the underlying disease process, rather than simply treating the symptoms. Incannex has demonstrated that IHL-675A components, CBD and HCQ, act synergistically to inhibit production of key inflammatory cytokines in an in vitro study of human cells and in four distinct successful in vivo experiments using established models of inflammation.
Incannex has evaluated the results of these experiments and believe IHL-675A to be a multi-use drug candidate suitable for the prevention and treatment of inflammation, with an initial focus on inflammatory lung conditions (acute respiratory distress syndrome, COPD, asthma, and bronchitis), rheumatoid arthritis, and inflammatory bowel disease.