Incannex Healthcare Inc (NASDAQ:IXHL), a pharmaceutical company developing novel medicinal cannabinoid pharmacotherapies and psychedelic medicine therapies for unmet medical needs, has started patient dosing in a Phase 2 clinical trial assessing IHL-675A in patients with rheumatoid arthritis (RA).
IHL-675A is the company’s proprietary combination drug candidate composed of Hydroxychloroquine Sulfate (HCQ) and cannabidiol (CBD), both of which have well-characterized anti-inflammatory activity when administered individually.
About the trial
The trial will enroll 128 participants across 10 study sites in Australia with participants receiving either IHL-675A, CBD, HCQ or placebo.
Participants will record their pain and function outcomes daily, by completing questionnaires on pain, fatigue, joint stiffness and quality of life, using an electronic Patient Reported Outcomes device.
The primary endpoint of the double-blind, Phase 2 clinical trial is pain and function relative to baseline determined via the score on the RAPID-3 assessment at 24 weeks.
“An exciting milestone”
Incannex chief scientific officer Dr Mark Bleackley said: “Commencing dosing in the Phase 2 clinical trial in patients with RA is an exciting milestone for the development of IHL-675A.
“Millions of people are affected by pain associated with rheumatoid arthritis despite the available treatment options. IHL-675A has the potential to address this unmet need.
“We look forward to generating data on the safety and efficacy of IHL-675A and sharing this data with FDA and other regulatory agencies.”
Monthly visits
Participants in the Phase 2 trial will attend monthly visits at the clinical trial site, where blood tests and physical examinations will monitor additional safety and efficacy outcomes including inflammatory biomarkers.
The trial will also include a sub-study examining joint inflammation and damage via Magnetic Resonance Imaging (MRI).
Results of this trial will be a critical component of future regulatory applications, including contributing to the combination rule assessment in the FDA505(b) new drug application (NDA) dossier.
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.
How IHL-675A works
HCQ acts by interfering with antigen presentation and lysosomal acidification whereas CBD modulates the activity inflammatory signalling receptors.
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.