Paradigm Biopharmaceuticals (ASX: PAR) has fully recruited trial participants for its phase 2b clinical trial for knee osteoarthritis, leaving it on track to report trial results before the end of this year.
Paradigm chief executive, Mr Paul Rennie, said the fast recruitment showed the strong demand for a new “breakthrough’’ treatment for the treatment of painful osteoarthritis in the knee.
“The Paradigm clinical and regulatory team, along with all the clinical trial recruitment and treatment centres have done an extraordinary job to conclude the recruitment of this Phase 2 clinical trial in just over seven months,’’ said Mr Rennie.
“What further underlines the outstanding job is Paradigm’s second phase 2a clinical study (Ross River virus) is also nearing completion of recruitment.’’
Breakthrough treatment spurred on by positive patient report
Mr Rennie said injectable pentosan polysulfate sodium (iPPS) has the potential to be a “breakthrough” in the treatment of osteoarthritis, given that current treatments did not provide adequate pain relief or provide any protection for degenerating joint structures and were also associated with significant side effects.
He said strong media coverage of patients being treated under the TGA Special Access Scheme had boosted recruitment for the trial, along with public referral from patients treated by their doctors.
The primary outcome of the trial is to evaluate the effects of iPPS on knee pain in participants with knee osteoarthritis and subchondral bone marrow lesions (BMLs) as assessed the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscale.
Secondary outcome include changes in KOOS joint symptom score of the knee and MRI changes to BML volume.
FDA could fast track this treatment
Osteoarthritis 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, particularly as iPPS is not an opiod or a steroid, so it is non-addictive.
Mr Rennie said Paradigm believed iPPS has the potential to receive fast track designation from the US Food and Drug Administration (FDA), due to the high level of concern about the opioid epidemic.
Osteoarthritis (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
In Australia, OA 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.
Trial at six sites around Australia
The phase 2b trial will be double-blind and placebo controlled and take place in six sites in Queensland, Victoria, South Australia and Western Australia.
So far under the TGA special access scheme, there has been a consistent pain reduction of 50 per cent on average on the 75 patients that have been reported on, with a total of more than 370 OA patients treated so far under this regime.
Paradigm expects to report the results of the pivotal phase 2b clinical trial late in the fourth quarter of this calendar year.