Paradigm Biopharma (ASX: PAR) has recruited more than 80% of its patients needed for its phase 2b osteoarthritis and concurrent bone marrow lesion clinical trial, with results anticipated “ahead of schedule” in the December quarter of this year.
The company expects recruitment will be finished this month with the six treatment sites currently operational.
As part of the study, 260 osteoarthritis patients have been treated with Paradigm Biopharma’s pentosan polysulfate sodium drug via the Therapeutic Goods Association’s Special Access Scheme.
According to Paradigm Biopharma, this is almost double the number of patients treated since the company last reported on the process six weeks ago.
Patients in the trial suffer from osteoarthritis pain and current treatments including analgesics, corticosteroids and non-steroidal anti-inflammatory drugs have not been effective.
The company claims the rapid recruitment is a “strong indication” of the positive effect the pentosan polysulfate sodium drug is having on relieving pain.
“The speed at which the osteoarthritis trial is recruiting is very encouraging as it is quite rate for clinical trials to recruit ahead of expectations,” Paradigm Biopharma chief executive officer Paul Rennie said.
“We view this accelerated recruitment as an indication of not only the pain and discomfort that osteoarthritis sufferers are under, but also the dire need for new treatments that are safe and effective,” he added.
He said the “dramatic increase” in patients treated by their doctor under the Therapeutic Goods Association’s Special Access Scheme was also “encouraging”.
“We believe it shows that patients are achieving results that doctors are suitably impressed with to warrant doctors applying for access for their other osteoarthritis patients.”
Paradigm Biopharma claims its injectable pentosan polysulfate sodium has the potential to be a “break through” treatment for osteoarthritis because it offers pain relief and protection for degenerating joint structures, unlike therapies on the market.
As the most common form of joint disease in the world, Paradigm Biopharma estimates the treatment market for osteoarthritis is worth about US$5 billion per annum.
The company believes this figure could be higher if new effective treatments such as its pentosan polysulfate sodium are commercialised.
In the US, more than 30 million adults are afflicted with the condition with 3 million Australians also suffering.
Paradigm Biopharma claims the condition is the leading cause of pain and disability in both countries.
Ross River virus
In addition to its osteoarthritis clinical trial, Paradigm Biopharma has recruited more than 75% of the patients needed for its phase 2a study into the effectiveness of its pentosan polysulfate sodium on Ross River virus sufferers with painful joints.
Patients have been recruited across Queensland and Victoria to test the safety, tolerability and effects of pentosan polysulfate sodium on the disease’s associated joint pain.
“Paradigm hopes that the phase 2a trial will demonstrate the potential of pentosan polysulfate sodium as an effective treatment for patients with persistent joint symptoms following Ross River virus infection, where a treatment is desperately needed,” the company stated.
The company’s share price lifted more than 6% in mid-morning trade to hit A$0.50.