The trial will compare the effects of PPS subcutaneous injections to placebo on pain and function.

In the Phase III clinical trial of injectable pentosan polysulfate sodium (PPS/Zilosul) for the treatment of pain associated with Osteoarthritis Drugs Development Market in the United States, Paradigm Biopharmaceuticals has randomized and dosed the first participants.

The trial's first subject was randomly assigned at Northwestern University in Chicago, USA.

The adaptive, randomized, double-blinded, placebo-controlled, multicentre, international trial with the name PARA_OA_002 is comparing subcutaneous injections of PPS to placebo in people with kOA pain to see how pain and function change.

It will consist of two stages to measure the dose and effectiveness of iPPS treatment for kOA pain in trial participants.

Phase IIb dose selection will be part of Stage 1, and subjects will be randomly assigned to one of the three iPPS regimens or a placebo for six weeks.

The primary goal of stage 1 of the trial is to find the dose for use in stage 2 and Paradigm's confirmatory trial, PARA_OA_003.

The dosage will be determined by determining the best balance between safety and effectiveness.

In the second stage of the trial, subjects will be assigned in a 1:1 ratio to receive either PPS or a placebo for six weeks.

The primary endpoint of the trial is WOMAC pain variation on Day 56 compared to baseline.

Quality of life, WOMAC pain and function variation from baseline at various points up to day 168, and the patient's global impression of change are secondary outcomes.

Eight sites in Australia and 21 of the 56 selected sites in the United States are currently undergoing subject screening and enrollment.

The remaining sites in the United States will be activated, and sites in the United Kingdom and the European Union will be launched throughout the year.

Dr. Donna Skerrett, interim chief medical officer and CEO of Paradigm, stated: An important turning point in the OA clinical program is the randomization of our first subjects in the United States.

"We are seeing a large number of subjects entering the screening phase throughout the US," states the Paradigm clinical team, "who have been working tirelessly to initiate and activate sites throughout the US."

The business presented positive real-world evidence of its iPPS in 205 kOA patients in May 2019.