Paradigm Biopharmaceuticals Ltd. reported that the first subjects have been randomised and dosed in the pivotal PARA_OA_002 clinical trial, evaluating injectable pentosan polysulfate sodium (iPPS/Zilosul®) for the treatment of pain associated with knee osteoarthritis (kOA). The first subjects were enrolled by Dr. Arya, Australian Clinical Research Network, NSW. Of the eight sites that have been qualified in Australia, four sites are currently screening and dosing subjects, with the remaining four scheduled to begin screening activities during January.

The purpose of this study is to measure the change in pain and function with subcutaneous injections of PPS compared with subcutaneous injections of placebo in participants with kOA pain. This is a 2-stage, adaptive, randomised, double-blind, placebo-controlled, multicentre (US/AUS/UK/EU) study that will evaluate the dose and treatment effect of iPPS in participants with kOA pain. Stage 1 comprises a phase 2b dose selection, with participants randomised receiving 1 of 3 iPPS dose regimens or placebo for 6 weeks.

The primary objective of stage 1 is to select the dose for use in stage 2 and Paradigm's confirmatory trial (PARA_OA_003), the selected dose will be based on an optimal balance of efficacy and safety. In stage 2, participants will be randomised 1:1 to receive the selected PPS dose regimen or placebo for 6 weeks. The primary endpoint in the pivotal study is a change from baseline at Day 56 in WOMAC® pain with secondary outcomes including change from baseline at multiple time points out to day 168 in WOMAC® Pain and Function, Patient Global Impression of Change and Quality of Life.