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- Paradigm Biopharma (ASX:PAR) reports injectable pentosan polysulfate has led to a decrease in self-reported pain in osteoarthritis (OA) patients
- The company says results show iPPS is likely a superior drug compared to other major treatment options
- Placebo patients took five times as many painkillers as those receiving iPPS injections
- These results are for a year-long phase two study with a phase three study active in the background
- Paradigm has made applications to the TGA
- Shares are up 11 per cent, trading at 65.5 cents at 12:35 pm AEST
Paradigm Biopharma (ASX:PAR) has reported that its year-long trial using injectable pentosan polysulfate (iPPS) resulted in osteoarthritis (OA) patients reporting decreased pain.
Paradigm has now lodged a provisional approval application to the Therapeutic Goods Administration (TGA), Australia’s answer to the US FDA.
Research using iPPS in the past has shown that the drug apparently caused a regeneration of knee cartilage in patients with painful knee arthritis. That was in 2010.
Paradigm today reported that iPPS “meaningfully” led to pain reduction in knee-related OA patients. The company further said no OA drug as a single course of treatment has ever done the same.
Patients received two milligrams per kilogram of iPPS twice weekly for six weeks.
These results come in after the trial has run for a calendar year. The company reported that by day 56, patients were presenting with structural improvements in the bone marrow.
As evidence that iPPS alone can lead to significant pain reduction, Paradigm notes that placebo patients took five times more painkillers for breakout pain than those who received iPPS. Study participants were tasked with self-reporting pain.
“Secondary Objectives included … evaluating the effect of iPPS on serum and urine biomarkers associated with inflammation and OA disease progression in participants with knee OA pain” the company wrote.
Phase three trials remain ongoing at the same time the company reports its Phase two results today, outlining apparent success.
The company believes iPPS has outperformed other treatments including paracetamol, corticosteroids and hyaluronic acid; the latter two being injectables like iPPS.
The Australian Institute of Health and Welfare estimates more than two million Australians present with OA, though, not all may report pain. That equals to more than nine per cent of Australian residents with the gender breakup being 12 per cent women at 6.8 per cent men.
PAR shares were up 11 per cent, trading at 65.5 cents at 12:35 pm AEST.
