Late-stage drug development company Paradigm Biopharmaceuticals (ASX: PAR) has announced positive study data from a Phase 2 clinical trial of injectable pentosan polysulfate sodium (iPPS) for the treatment of acute pain associated with knee osteoarthritis.
The study investigated changes in synovial fluid biomarkers with iPPS treatment compared with placebo in 61 participants administered with twice-weekly subcutaneous injections of iPPS dosed at 2 milligrams per kilogram body weight.
The primary endpoint was a change from baseline at Day 56 in one or more synovial fluid biomarkers of inflammation, pain and joint degradation.
Secondary objectives included determining the correlation between synovial fluid biomarkers and clinical outcomes; determining the correlation between biomarkers in synovial fluid and those in serum and urine; and evaluating the effect of iPPS on serum and urine biomarkers associated with inflammation and disease progression.
The company reported that participants showed positive outcomes in pain and functioning over a 12-month duration.
At Day 56 after treatment, “significant and clinically-meaningful improvements” were recorded in knee pain, function, stiffness and overall scores in the iPPS treatment groups compared to placebo.
At Day 168, the treatment demonstrated reduced cartilage loss (indicating cartilage preservation), reduced bone marrow lesions and reduced osteophyte formation (bone spurs) compared to placebo.
Paradigm managing director Paul Rennie said the twice weekly dose of iPPS was preferred for the trial over the previous once per week regime.
“To achieve clinically meaningful and significant results with iPPS at a dose of 2mg/kg twice weekly compared to placebo at 12 months in only a small number of subjects per treatment arm shows clear strength in this treatment regimen over placebo,” he said.
“The 12-month durability of effect on osteoarthritis pain and function following one six-week course of treatment is truly an outstandingly positive trial outcome and separates iPPS from all currently available therapies for knee osteoarthritis.”
Mr Rennie said iPPS had the potential to change the osteoarthritis treatment landscape as no currently-approved drug had shown the same improvements in pain and function at 12 months after a single course of treatment.
“This could become an early intervention or first-line therapy in the osteoarthritis treatment algorithm, with the potential to reduce reliance on other agents such as opioids, NSAIDs (non-steroidal anti-inflammatory drugs) and corticosteroids,” he said.