Paradigm receives ethics approval for osteoarthritis trial

Paradigm Biopharmaceuticals 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).

The ethics approval allows Paradigm to commence the trial at its four clinical trial sites: the Griffith University Clinical Trials Unit in Queensland, Sportsmed SA Hospital in Stepney, South Australia, Emeritus Research in Malvern East, Victoria, and Linear Clinical Research in Nedlands, Western Australia. The randomised, double-blind, placebo-controlled Phase 2b clinical trial will treat a total of 100 patients with results expected in Q1 CY2019. A positive result from the trial would be a major valuation inflection point for Paradigm.

First participant dosing is expected in the coming weeks. Participants with OA of the knee and subchondral bone marrow lesions will be evaluated for safety, tolerability, pain levels and effects on disease symptoms of PPS subcutaneous injections. The trial will be run by principal investigator Associate Professor Andrew Ostor, Paradigm’s clinical research partner.

It is estimated that the OA market is worth US$5 billion a year and this figure could potentially be multiples higher if new, effective, patented treatments such a PPS are commercialised.

In Australia, about 19,000 hip replacements and 25,000 knee replacements are performed for OA patients each year, representing a direct healthcare cost in excess of AU$475 million and AU$500 million, respectively.

In the US, the financial burden has been estimated to be US$81 billion in medical costs and US$128 billion in total costs, given approximately 27 million people have OA associated limitations, while there are 36 million outpatient visits and 750,000 hospitalisations a year.

The ethics approval follows Paradigm confirming case reports of strong clinical outcomes for PPS, which confirm the significant potential for the drug to treat BMELs in people with OA.

Paul Rennie, Paradigm’s CEO, said: “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.

“We hope PPS can provide the two major goals of physicians and their OA patients alike — ie, significantly reduce OA pain and stop or slow the structural destruction of the joint. 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.”