Paradigm Biopharmaceuticals (ASX: PAR) has recorded pleasing trial results for its Pentosan Polysulfate Sodium (PPS) drug. In a statement to the market, Paradigm said that “84.4% responded with both a reduction in joint pain and an improvement in knee function.”
Patients were treated by their doctor with injectable Pentosan Polysulfate Sodium under the Therapeutic Goods Administration’s Special Access Scheme (SAS), with results showing patients’ pain scores were reduced by 50% (on average) from baseline pain scores in 45 patients with knee osteoarthritis (OA) and concurrent Bone Marrow Lesions (BML).
Pentosan Polysulfate Sodium is a semi-synthetic drug manufactured from European beech xylans that are sulphated to produce a negatively charged product that mimics glycosaminoglycans (GAGs).
Paradigm says these complex carbohydrates have a regulatory role in the body through interacting with proteins involved in inflammation.
In its most recent trial, patients were administered with two injections of Pentosan Polysulfate Sodium per week for three to six weeks depending on the severity of the BMEL (a total of 6 to 12 injections). Patients were followed up at four weeks following the last treatment.
Paradigm says that “the 50% reduction in pain scores observed with PPS in knee OA demonstrates superiority over the 15% pain reduction scores reported for opioid treatments for chronic pain in OA of the knee and hip.”
The emerging biotech firm also said that the comparative effects of PPS therapy against opioid treatments imply that the patient-reported data have “provided evidence of clinically meaningful improvements in chronic pain.”
In addition to today’s published results, Paradigm is expecting the receipt of more thorough results from Paradigm’s Phase 2b randomised, double-blind, placebo-controlled, multicentre, clinical trial, expected in Q4 2018. By this point, Paradigm expects to supplement its existing clinical study with an additional 150 RWE patients.
Paul Rennie, Paradigm’s Chief Executive Officer said: “We are very pleased to see the second group of Real World Evidence patients report results that are consistent with the first group of patients we treated under the program.”
“Of great importance to us is that Paradigm now has data on 45 patients being successfully treated with PPS for OA associated BMELs.”
“It is a significant positive outcome that all these patients have on average, a clinically meaningful reduction in pain of 50%. Given these patients have a very similar treatment regimen to subjects being treated under the current Phase 2b Osteoarthritis randomised, double-blind, placebo-controlled, clinical trial and these patients have failed current therapies to treat OA, we remain confident of a positive clinical trial outcome, with the expected release of top-line results for that trial due in Q4 2018.”