Paradigm Biopharmaceuticals Ltd (ASX:PAR) has randomised its first UK subject and kicked off dosing in the pivotal PARA_OA_002 phase 3 study, evaluating injectable pentosan polysulfate sodium (iPPS/Zilosul®) for the treatment of pain associated with knee osteoarthritis (OA).
Notably, the company aims to activate a total of seven sites across the UK for this phase 3 study.
To date, more than 50 sites across three jurisdictions are actively screening and recruiting candidates.
“Important milestone”
Paradigm CMO Donna Skerrett said: “To have our first participant randomised outside of the US and Australia is another important milestone in our global phase 3 program.
“Dr Pandit and his team at Leeds University have demonstrated a strong interest in the Paradigm OA clinical program and we look forward to many more participants joining the study throughout the UK.”
Study stages
The purpose of this pivotal phase 3 study is to establish the efficacy of subcutaneous injections of PPS (iPPS) participants with knee OA pain
It is a two-stage, adaptive, randomised, double-blinded, placebo-controlled, multicentre (US/CAN/AUS/UK/EU) study that will evaluate both the dose and treatment effect of iPPS in participants with knee OA pain.
Stage 1 will comprise a phase 2b dose selection component, with randomised participants receiving 1 of 3 iPPS dose regimens or placebo for six weeks.
In stage 2, participants will be randomised 1:1 to receive the selected PPS dose regimen or placebo for six weeks.
Outcomes
The primary endpoints in this pivotal study are changes from baseline at day 56 (two weeks after the final dose) in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain.
Secondary outcomes include change from baseline at multiple time points out to day 168 (24 weeks from the start of the study, and 18 weeks after the last treatment) in WOMAC pain and function, Patient Global Impression of Change (PGIC), and Quality of Life (QoL) assessments.