Incannex Commences Dosing in Phase 2 Clinical Trial Assessing IHL-675A in Patients with Rheumatoid Arthritis - Seite 2

Background
IHL-675A is a combination drug candidate comprised of hydroxychloroquine sulfate (HCQ) and cannabidiol (CBD). HCQ is listed as an essential medicine by the World Health Organisation and was developed as an anti-malarial drug, but its anti-inflammatory activity has led to use in treatment of RA and lupus erythematosus. CBD is approved for use in seizure disorders but is also commonly used for RA as an unregistered therapy. The established use of the component active pharmaceutical ingredients to treat RA makes IHL-675A a strong candidate for treatment of RA. IHL-675A is also a potential treatment for other inflammatory conditions such as inflammatory bowel disease, COPD and asthma.

HCQ acts by interfering with antigen presentation and lysosomal acidification (2) whereas CBD modulates the activity inflammatory signalling receptors (1). Anti-inflammatory synergy between the two drugs was demonstrated across a range of preclinical studies and have provided the foundation for a robust intellectual property (IP) position over the IHL-675A drug candidate.

A video presentation of IHL-675A for treatment of rheumatoid arthritis can be found at  https://www.incannex.com/clinical-trail/ihl-675a-rheumatoid-arthritis/.

Chronic inflammatory conditions affect tens of millions of people globally. Rheumatoid arthritis (RA) is estimated to have a global prevalence of 0.46% (3), which equates to approximately 36.8 million people with RA. Inflammatory bowel disease (IBD) has a global prevalence of 6.8 million (4). Estimated global prevalence of chronic obstructive pulmonary disease and asthma (COPD) are 391.9 million and 357.4 million respectively (5, 6).

Overview of Results from Phase 1 Clinical Trial Assessing Tolerability, Safety, and Pharmacokinetics of IHL-675A in Healthy Volunteers
In 2022 and 2023, Incannex undertook a Phase 1 clinical trial to assess the safety, tolerability, and pharmacokinetics of IHL-675A. The key endpoints of the trial were adverse events and the plasma levels of the active pharmaceutical ingredients (APIs), CBD and HCQ, and their major metabolites over a 28-day period. IHL-675A was compared to the reference listed drugs for CBD and HCQ, called Epidiolex and Plaquenil respectively, across all endpoints. The trial included three cohorts of twelve participants each (total n = 36), with equal evaluations applied across all three groups. Participants were monitored and had blood samples collected for pharmacokinetic analysis over a 28-day period. IHL-675A was well tolerated, with no adverse events of concern and no serious adverse events reported. The same number of treatment related treatment emergent adverse events (TEAEs) were reported for IHL-675A as for Epidiolex.