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Paradigm Biopharma’s clinical trials in the fast lane

Paradigm Biopharmaceuticals (ASX: PAR) is surpassing its own expectations in recruiting patients for its two phase two clinical trials, which will speed up the announcement of potential company making results.
Paradigm chief executive, Mr Paul Rennie, said the excellent recruitment numbers were a strong pointer towards the large unmet clinical need for effective treatments for osteoarthritis and joint pain caused by the mosquito borne virus Ross River Fever.
First results in the fourth quarter of 2018
Paradigm’s phase 2b clinical trial for patients with knee osteoarthritis and concurrent bone marrow lesions is now more than 50 per cent recruited and remains well ahead of schedule with an expected read out in the fourth quarter of the 2018 calendar year.
The addition of a sixth clinic with extensive clinical trial experience in Brisbane will also help to speed recruitment and results.
First Ross River results set for third quarter of 2018
Similarly, the phase 2a clinical trial in participants with viral arthralgia (sore joints caused by Ross River virus) is currently more than 70 per cent recruited and is scheduled to recruit further after the seasonal recurrence of the disease.
“The clinical trials are aimed at diseases for which there are very few safe and effective drugs meaning Paradigm is focussing on market sectors where there are high levels of unmet medical needs and high levels of commercial interest,’’ said Mr Rennie.
“Investors will also note that the completion of phase 2 clinical trials are major value inflection points.’’
Already plenty of regulatory safety data about PPS
Both trials are repurposing an existing drug used to treat bladder problems – Pentosan Polysulfate Sodium (PPS) – which means that there is a large amount of safety data already with regulatory authorities, potentially speeding up regulatory approval for the drug for other uses in many countries.
PPS is already successfully used for treating osteoarthritis in animals such as dogs and horses and has significant anti-inflammatory properties that can improve joint function and pain scores.
In addition to the two main phase 2 clinical trials, PPS is also being supplied to a total of 147 osteoarthritis patients who have failed to respond to other treatments through the Therapeutic Drug Administration’s (TGA) Special Access Scheme.
Currently 45 out of the 147 patients have completed PPS treatments which has demonstrated a clinically meaningful response with an average of a 50 per cent reduction in pain scores with a high level of statistical significance.
Paradigm will report on the remaining patients when the PPS treatments are finished.
Pentosan Polysulfate Sodium is a semi-synthetic drug manufactured from European beech xylans that are sulphated to produce a negatively charged product that mimics glycosaminoglycans (GAGs).
Paradigm says these complex carbohydrates have a regulatory role in the body through interacting with proteins involved in inflammation.
Paradigm has previously reported that the comparative effects of PPS therapy against opioid treatments imply that the patient-reported data have “provided evidence of clinically meaningful improvements in chronic pain.”
Osteoarthritis is a massive market with a lack of novel treatments
Osteoarthritis (OA) is a condition with a significant unmet medical need, with a market size of US$5 billion a year, with low-cost, generic treatments making up much of that total.
That market size could increase greatly if a new, effective and patented treatment is commercialised.
OA is the most common form of joint disease worldwide, affecting as much as 13 per cent of the world’s population.
In the US alone, the financial burden of OA has been estimated to be US$81 billion in medical costs and US$128 billion in total costs, given approximately 21 million people have OA associated limitations, while there are 36 million outpatient visits and 750,000 hospitalisations per year.
Three million people in Australia alone
In Australia, arthritis affects around three million people or around 15 per cent of the population. OA is the leading cause of pain and disability among the elderly in Australia and the third-leading cause of life-years lost due to disability.
About 19,000 hip replacements and 25,000 knee replacements are performed for osteoarthritis in Australia each year, representing a direct healthcare cost in excess of A$475 million and A$500 million, respectively.
The prevalence of OA is also set to rise globally with ageing populations accompanied by the rising epidemic of obesity. OA most commonly affects large weight-bearing joints, affecting the knees in up to 37 per cent of adults over 60.
Pain is the major symptom for people with OA, with 17 per cent of US adults aged 45 and older reporting pain as the predominant clinical problem.
OA pain is most commonly treated with analgesics, NSAIDs and corticosteroids.