Paradigm Biopharmaceuticals Ltd (ASX:PAR) has completed randomisation and begun dosing the first US subjects in the PARA_OA_002 phase 3 study evaluating injectable pentosan polysulfate sodium (PPS/Zilosul®) for the treatment of pain associated with knee osteoarthritis (kOA).
This global pivotal study is screening and enrolling subjects in eight sites in Australia and 21 of 56 selected sites in the US. Paradigm has been keenly focused on ensuring a large pool of potential candidates are available for screening.
Site activations in the US will continue and UK and EU sites will also be initiated throughout the calendar year.
“Important milestone” in clinical program
“To have our first subjects randomised in the US is an important milestone in the OA clinical program,” Paradigm Biopharmaceuticals chief medical officer and interim CEO Dr Donna Skerrett said.
“The Paradigm clinical team has been working tirelessly to initiate and activate sites throughout the US and we are seeing a large number of subjects entering the screening phase throughout the US.
“We look forward to continuing the strong momentum in the phase 3 program and reporting important recruitment milestones to our shareholders.”
Shares higher
PAR shares have been as much as 13.9% higher intraday to A$1.40 while the company's market cap is approximately A$290.18 million.
The Para_OA_002 trial is a 2-stage, adaptive, randomised, double-blinded, placebo-controlled, multicentre (US/CAN/AUS/UK/EU) study that will evaluate the dose and treatment effect of injectable PPS in participants with kOA pain.
Stage 1 will consist of a phase 2b dose selection, with participants receiving 1 of 3 randomised injectable PPS dose regimens or placebo for six weeks.
Paradigm aims to use data from this first stage to select the dose for use in stage 2 and the company’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 six weeks.
The primary endpoints in the pivotal study are change from baseline at Day 56 in WOMAC® pain with secondary outcomes to include 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.