Paradigm Biopharmaceuticals (ASX: PAR) has reported an 83% pain reduction for osteoarthritis patients who were retreated with the company’s Pentosan Polysulfate Sodium (PPS).
Current treatments for osteoarthritis are limited with minimal impact on pain. Opioids are increasingly being prescribed and come with their own set of issues including potential addiction and overdose. Additionally, existing treatments do not slow or reverse the degeneration of join structures.
To-date, the semi-synthetic PPS has been used in treating equine osteoarthritis with beneficial outcomes. It has also been used in treating other ailments in humans and possesses several anti-inflammatory and disease modifying properties.
In Paradigm Biopharmaceuticals’ recent case study of 24 patients, people suffering from bone marrow edema lesions (BMELs) and osteoarthritis were treated with the PPS under the Therapeutic Goods Administration’s special access system. The patients, with an average age of 57.5 years, were administered PPS intramuscularly twice-weekly for three weeks.
Prior to treatment with PPS, all patients had suffered from osteoarthritis pain for a minimum of six months, and standard therapy avenues of analgesics, non-steroidal anti-inflammatory drugs or corticosteroids had failed.
Two weeks post-treatment, 20 out of 24 (83%) patients reported their pain had diminished, and 80% recorded improved knee function.
The US Food and Drug Administration allows the real-world data from these case studies to be used in conjunction with randomised controlled clinical trials to support product registration.
By the end of 2018, Paradigm Biopharma has targeted the completion of a further 75 case studies. This is in addition to the company’s recently started phase 2b randomised, double-blind, placebo-controlled clinical trial, which includes 100 patients.
Because the condition is currently inadequately treated, Paradigm Biopharma believes the osteoarthritis markets offers the company a “significant” opportunity.
Market opportunity in treating osteoarthritis
According to Paradigm Biopharma, the therapeutic market for treating osteoarthritis is worth US$5 billion per annum, with the current financial burden to the US economy sitting at almost US$130 billion.
In Australia arthritis impacts three million people. Consequently, there is the financial encumbrance with the Australian health care system forking out almost $1 billion a year on more than 44,000 hip and knee replacements.
The prevalence of osteoarthritis is predicted to increase as the population ages and obesity rates rise.
PPS has been shown to be safe and effective in reducing pain and may stop or slow the degeneration process in osteoarthritis.
Other advantages to PPS include its pre-existing use in humans, little gastro-intestinal side effects and it is nonaddictive.
Shares in Paradigm Biopharmaceuticals were up almost 20% in early afternoon trade.