Medical cannabinoid company Incannex Healthcare Limited (ASX: IHL) announced early last week it had commenced a Phase 2 clinical trial to assess the safety and efficacy of a drug containing CBD targeting rheumatoid arthritis.
Rheumatoid arthritis is a chronic inflammatory disease where the immune system attacks healthy joint tissues. This leads to pain, swelling and joint stiffness. The condition can also affect other tissues including skin, eyes, lungs, heart and blood vessels. While there are a number of drugs available for rheumatoid arthritis, their effectiveness can be hit and miss, side effects problematic and costs prohibitive.
Rheumatoid arthritis affects a lot of people, and it’s also big business – one estimate pegs the rheumatoid arthritis drugs market to hit USD $62.9 billion by 2027.
Cannabidiol (CBD) is known to have anti-inflammatory effects, and it’s hoped this attribute could bring relief to rheumatoid arthritis patients. But as well as cannabidiol, Incannex’s proprietary anti-inflammatory combination drug IHL-675A also contains hydroxychloroquine (‘HCQ’).
In July last year, Incannex was given a green light for a Phase 1 clinical trial of IHL-675A, which the company says found the formulation to be well tolerated, with no adverse events of concern.
The Phase 2 trial will assess the efficacy, safety and tolerability of IHL-675A compared to its respective components, CBD and HCQ, and placebo. The double-blinded trial involves 120 participants who will be randomised to one of four groups: those receiving either IHL-675A, CBD alone, HCQ alone or placebo.
“This trial is a key milestone in the IHL-675A development program,” said Incannex Chief Scientific Officer Dr Mark Bleackley. “We are excited to continue the development of this drug product to determine whether the remarkable preclinical efficacy we observed for IHL-675A in an animal disease model for arthritis is also seen to a similar extent in humans.”
The trial will be managed by Avance Clinical, which specialises in delivering quality clinical trials; with globally accepted data, in Australia, New Zealand and the US.
If IHL-675A proves to be successful in treating rheumatoid arthritis, it may not be a one-trick pony. Incannex is also investigating the potential for IHL-675A to treat inflammatory lung diseases such as COPD, asthma and ARDS, and inflammatory bowel disease.