Paradigm Biopharmaceuticals Ltd (ASX:PAR) has received ethics approval for its Phase 2b clinical trial to investigate Pentosan Polysulfate Sodium (PPS) in subjects with knee osteoarthritis (OA) and bone marrow edema lesions (BMELs).
Paradigm will investigate if the injectable PPS could be a safe and effective treatment for OA.
Currently, treatments do not have adequate pain-relieving effects, and provide no protection for the degenerating joint structures.
They are also associated with significant adverse side effects.
Paul Rennie, chief executive officer, commented:
"This is an important clinical trial as injectable PPS could be a promising, safe and effective treatment for BMELs in people with knee OA – a condition with significant unmet medical need.
"Most current treatments do not effectively address the disease and can have destructive effects on joint structure or adverse side effects."
The major goals are targeting a reduction in OA pain, and to stop or slow the structural destruction of the joint.
Rennie added: "Additionally, we hope PPS may offer an alternative to the use of opioids for treating OA pain.
"We look forward to commencing recruitment for the trial over the coming weeks."
The trial will recruit 100 patients across four sites in Queensland, South Australia, Victoria and Western Australia.
The trial subjects will be evaluated for safety, tolerability, pain levels and effects on disease symptoms.
Results are anticipated in early 2019.
The OA market represents a significant opportunity for Paradigm.
It is a condition with a large and, as yet, unmet medical need as most current treatments prescribed for the condition do not have adequate pain-relieving effects, provide no protection for the degenerating joint structures and are also associated with significant adverse side effects.
It is estimated that the size of the market is US$5 billion per annum and this figure could potentially be multiples higher if new, effective, patented treatments such a PPS are commercialised.
OA also remains the most common form of joint disease globally.
In the US alone, it affects more than 27 million adults, while in Australia, arthritis affects around three million people.
In both countries, the condition is a leading cause of pain and disability among the elderly and a cause of life-years lost due to disability.