Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL) has kicked off a Phase 2 clinical trial, testing the safety and efficacy of its IHL-657A drug candidate in patients with rheumatoid arthritis.
Research firm Avance Clinical will manage the trial across up to 10 sites in Australia and New Zealand, overseeing responses from 120 participants as they evaluate how IHL-657A treats patient pain and function over 24 weeks.
Participants may also join an extension study following the trial, while patients who meet the criteria for joint damage may also be included in a magnetic resonance imaging assessment sub-study.
The Phase 2 trial follows in the footsteps of Incannex’s Phase 1 and animal studies, which showed that IHL-657A was well tolerated and reduced disease scores to a greater extent than hydroxychloroquine (HCQ), a common long-standing prescription drug for rheumatoid arthritis.
Once results come to hand, Incannex will have a clearer picture of IHL-657A’s safety and efficacy. The findings will contribute to combination rule assessment in the company’s new drug application dossier.
“Big step towards improving quality of life”
Incannex chief scientific officer Dr Mark Bleackley said the Phase 2 trial was a key milestone in IHL-675A’s development program.
“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.
“Arthritis is a disease that negatively impacts the well-being of millions of people worldwide and this trial is a big step toward Incannex potentially improving quality of life for these patients.
“We look forward to continuing to build our research relationship with Avance Clinical, who did an outstanding job managing the Phase 1 clinical trial assessing the tolerability and pharmacokinetics of IHL-675A in healthy volunteers.”
About IHL-675A
Incannex’s IHL-675A drug candidate includes a combination of HCQ, an expired patent registered pharmaceutical drug, and cannabidiol (CBD).
HCQ is a disease-modifying anti-rheumatic drug that regulates the activity of the immune system, which may be overactive in some conditions. It’s special because it can modify the underlying disease process, rather than simply treating the symptoms.
With IHL-675A, Incannex has shown that CBD and HCQ act synergistically to inhibit production of key inflammatory cytokines. The biotech has completed an in vitro study of human cells and four distinct successful in vivo experiments using established models of inflammation.
HCQ is already approved for the treatment of rheumatoid arthritis and is used by a significant cohort of patients with the disease. Many patients are also reportedly using non-cGMP grade CBD to ameliorate their symptoms.
As a result, Incannex is out to secure Food and Drug Administration (FDA) marketing approval for a pharmaceutical-grade IHL-675A product that can be prescribed by a patient’s doctor.
Considering CBD and HCQ’s synergies, Incannex believes that IHL-675A has multi-purpose drug potential. The candidate is suitable for preventing and treating inflammation, with a focus on conditions like rheumatoid arthritis, inflammatory lung conditions (acute respiratory distress syndrome, COPD, asthma, and bronchitis), and inflammatory bowel disease.
Altogether, the global treatment market for these indications is estimated at a whopping US$125 billion. IHL has completed a pre-investigational new drug (IND) meeting with the FDA to discuss the regulatory pathway for IHL-675A’s development in the United States, and it plans to open INDs for each of the three indications.