Biotech company Paradigm Biopharmaceuticals (ASX: PAR) has added more patients to its trail of injectable Pentosan Polysulfate Sodium (PPS), whilst maintaining its 50% pain reduction rate.
The biotech developer has added a further 30 patients with osteoarthritis to the scheme bringing the total to 75. The key takeaway is that PPS has reproduced its previously reported 50% pain reduction rate with the addition of more patients.
Paradigm is on track to prove the effectiveness of its PPS treatment by conducting a phase 2b clinical trial and administering it under the Therapeutic Goods Administration’s (TGA) Special Access Scheme (SAS). The trial is expected to be completed by the end of 2018 with more than 200 patients potentially being included in the results.
Paradigm has also courted the attention of several AFL football clubs that are currently using its breakthrough “paradigm shift” treatment that reduced joint pain and improves knee function in 84% of patients.
The news is significant because it adds further evidence that PPS can successful reduce joint pain with Paradigm adding that it “demonstrates superiority over the 15% pain reduction scores reported for opioid treatments” that are currently being used to treat patients.
The comparative effects of PPS therapy against opioid treatments implies that the patient-reported data have provided evidence of clinically meaningful improvements in chronic pain.
As the most common form of joint disease in the world, Paradigm estimates the treatment market for osteoarthritis is worth about US$5 billion per year. If Paradigm manages to commercialise its PPS treatment, it could potentially scoop a large portion of the market given the positive results recorded so far including amongst high-profile athletes in the AFL.
Amongst the average public, more than 30 million adults are afflicted with osteoarthritis in the US and around 3 million in Australia.
“We are very pleased to see the third group of real-world evidence patients report results that are consistent with the first and second groups of patients we treated under the program,” said Paradigm’s CEO Paul Rennie.
“The number of patients seeking treatment via the TGA SAS is accelerating, which we believe is a strong indication that the patients are receiving a clinical benefit from the iPPS treatment”.
“We feel particularly confident regarding a positive clinical trial outcome, with the expected release of headline results for that trial due in Q4 2018,” said Mr Rennie.
In addition to announcing results for an additional 30 patients today, Paradigm said that its phase 2b clinical trial will be supplemented by additional patient groups “as and when they are ready to report”, which is likely to mean the biotech developer will report further results later this year.