Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL) has completed the dosing stage in its Phase 1 anti-inflammatory drug trial.
The early-stage study is assessing the safety, tolerability and pharmacokinetic profiles of Incannex’s IHL-675A treatment candidate, a combination cannabinoid drug that delivers cannabidiol (CBD) and hydroxychloroquine (HCQ).
So far, results indicate that IHL-675A has been well tolerated by the trial’s participants, with no adverse events of concern reported to date.
The clinical-stage pharmaceutical company is now readying for Phase 2 trials in patients with rheumatoid arthritis. Down the line, it will also study the impact in participants with inflammatory bowel disease and lung inflammation.
Together, these three indications have a combined global, annual market size exceeding US$125 billion.
Potential in arthritis market
As it wraps up the Phase 1 dosing, Incannex is also preparing for a pre-investigational new drug (IND) meeting with the Food and Drug Administration (FDA) to develop IHL-675A specifically for patients with arthritis.
The company intends to open an IND in parallel with the Australian Phase 2 study.
Interestingly, HCQ is widely used to treat rheumatoid arthritis in the form of hydroxychloroquine sulphate, where it’s marketed as Plaquenil.
However, if Incannex can demonstrate that IHL-675A can improve a patient’s well-being, it could open up a major economic opportunity for the drug candidate to treat arthritis.
Many potential therapeutic uses
Incannex’s chief scientific officer Dr Mark Bleackley said: “It is an exciting milestone for us to complete dosing in our Phase 1 study on IHL-675A because it has so many potential therapeutic uses.
“At this stage, there have been no unexpected adverse events and the drug appears to be well tolerated.
“This gives our team the confidence to take the next steps necessary to commence Phase 2 clinical trials, initially in patients with arthritis, then in patients with lung inflammation and inflammatory bowel disease.”
IHL managing director and CEO Joel Latham went on to say that many people are using unapproved CBD or cannabinoids for inflammation-based disorders.
“By undertaking pivotal clinical studies over IHL-675A, and subject to ongoing clinical success, we intend to both disrupt the market for CBD and to open our product to the purview of medical professionals who are eminently more comfortable prescribing FDA approved, pharmaceutical grade products to their patients,” he explained.