Researchers within the PARC Clinical Research group at the Royal Adelaide Hospital are testing a new targeted treatment for osteoarthritis, potentially without the side effects of existing alternatives.
The XG004 gel is a combination of existing effective treatments, but can be applied directly to the skin, limiting the total dose of the drugs and their potential to effect other organs.
A growing problem
Australian population is getting older and as an age-associated condition, osteoarthritis is a growing concern as pain and reduced mobility can drastically limit a person’s independence and quality of life.
For relatively mild OA, paracetamol is often taken, which is limited in its effectiveness. Other treatments include anti-inflammatories such as naproxen, and gabapentinoids such as pregabalin, which target neuropathic pain caused by damage or injury to the nerves.
Oral medications such as these are systemic treatments, meaning they act on the whole body rather than a particular site of osteoarthritis, such as the knee.
As a result, they can cause unwanted side effects such as stomach irritation or bleeding, as well as kidney injury.
“Whilst they can be terribly effective, they’re not for everyone,” reflected principal investigator Professor Guy Ludbrook.
“We know that more people have kidneys that aren’t working perfectly as they get older, known as chronic kidney disease, so we try and steer away from anti-inflammatories in that space.”
A novel solution
XG004 is not the first topical (locally applied) treatment for osteoarthritis. While other single-drug products exist their effectiveness is limited, and patients can also require oral medications.
“We hope that by making gels that are more sophisticated, we can get a better effect. That might reduce or even remove the need for oral medications,” said Professor Ludbrook.
XG004 is a combination of components which are anti-inflammatory and which target persistent or neuropathic pain together in a gel which can be applied directly to the skin at the site of pain. This makes the total level of these drugs in the body almost undetectable which, the investigators hope, will markedly reduce or completely remove the potential for stomach, kidney or other problems.
“In a nutshell, you’ve got better ingredients that are working locally and not circulating in the body and causing adverse effects on other parts of the body,” said Professor Ludbrook.
The current study is a Phase 1b clinical trial, meaning it is concerned with evaluating safety. If the drug is proven to be successful in the future, the researchers hope that it would allow people to have more pain-free mobility, more independence and less need to go to the doctor.
“We want people to have better health and wellbeing and be able to be home with friends and family, working and living independently more often than they are currently,” said Professor Ludbrook.
The PARC Clinical Research group has a proven track record of undertaking rigorous high quality clinical research for the pharmaceutical and biotech industries; work which has been highly regarded by regulators such as the U.S. Food and Drug Administration, and Australia’s Therapeutic Goods Administration.
“The point we always make is that it’s our role here to tell companies what their drug does: good or bad. Our focus is on finding medicines which are safe, and provide positive health benefits for our patients,” said Professor Ludbrook.
The team at PARC Clinical Research are currently recruiting people with osteoarthritis of the knee to the trial.
People who would like to volunteer for the study should contact (08) 7074 4404 for more information.