Promising results as Paradigm repurposes drug for osteoarthritis

As the Australian pharmaceutical sector plans a crackdown on opioid oversupply to consumers, Paradigm Biopharmaceuticals (ASX:PAR) has released its progress results on repurposed thrombotic agent Pentosan Polysulfate Sodium (PPS) for the treatment of degenerative osteoarthritis and bone marrow edema lesions.

The injectable therapeutic is often used among athletes with acute knee injuries such as the dreaded torn ACL.

But Paradigm chief Paul Rennie says there is a much bigger market: an ageing and overweight population for whom osteoarthritis is a very real threat.

Osteoarthritis treatment now involves a lot of painkillers that aren’t effective enough, tend to cause heart and gastrointestinal problems and can cause ligament hardening and bone thinning.

Opioids are often prescribed for the pain — but they are addictive and only work temporarily until the dosage needs to be increased.

Australian medical authorities are now tightening opioid prescription. Many public health and medical authorities regret that the pharmaceutical was ever used outside the hospital setting.

About 19,000 hip replacements and 25,000 knee replacements are performed for osteoarthritis patients each year in Australia, costing about $475 million and $500 million respectively, Mr Rennie says.

Our increasing Body Mass Index means more stress on joints — which means we filling the health system with people in their 50s who can no longer work due to crippling osteoarthritis.

Paradigm hopes to get these people pain-free, and back into life without needing that joint replacement — potentially saving both patient and tax payer money in medication, time in the public health system, surgery, rehabilitation therapy and time off work.

Paradigm is using PPS, which has been used safely in patients for 60 years to treat conditions such as deep vein thrombosis.

Paradigm carried out clinical tests in 24 patients suffering at the worst stage of joint pain, many awaiting joint replacement surgery.

Injections were administered twice a week over a three-week period.

The results returned promising data, including significant pain relief and reduced swelling which led to improved mobility.

Paradigm has progressed to increased doses in similar tests to bring the total number of cases to 100. In September they began a new phase of randomised, double-blind, placebo-controlled clinical trials in 100 patients.

In 2013, half of new drugs in the US were repurposed drugs — though in Australia there is a much bigger focus on the development of new products.

Government business and research grants go to new developments, and Australian companies prefer to produce their own intellectual property rather than produce off-patent pharmaceuticals.

However, anti-microbial and anti-cancer drugs are a strong area of academic research in repurposing and there are discussions of using blood pressure medication to treat migraines.

Research doesn’t come free, however, and while there are many willing researchers out there ready to push the agenda forward, trials must be carried out on real live humans who have complicated health conditions and aren’t able to give up all their medications except the one being trialled.

Repurposing allows some shortcuts to be made, as contraindications may have already been established, but it still requires careful testing.

Paradigm is specialising in drug repurposing, and have other research in the works including respiratory, alphavirus (Ross River Fever and Chikungunya) and chronic obstructive pulmonary disease) for its PPS treatments.