Paradigm Biopharmaceuticals has selected Advanced Clinical as the clinical research organisation (CRO) to support its pivotal double-blind, multi-centre Phase III trial, PARA_OA_012, focused on treating osteoarthritis (OA).
The placebo-controlled trial is designed to assess the dose effect of injectable pentosan polysulfate sodium (iPPS) for knee OA pain.
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It aims to enrol nearly 466 subjects, with an interim analysis planned after day 112 using pain data from approximately half of the total sample size.
This trial builds on the promising outcomes from the company’s earlier Phase II studies, including PARA_OA_008, which showed a significant decrease in pain and an improvement in joint function from iPPS treatment for up to 12 months.
Advanced Clinical has been chosen as the preferred partner following a rigorous evaluation process involving seven global CROs.
From these, four were shortlisted to present detailed plans, with Advanced Clinical standing out for its capabilities and strategic alignment with Paradigm’s goals for the trial.
With the partnership now confirmed, Paradigm is preparing for the next stage, which includes site activation and subject recruitment.
Paradigm Biopharmaceuticals managing director Paul Rennie said: “We are delighted to partner with Advanced Clinical for our pivotal phase III clinical trial, PARA_OA_012. Advanced Clinical’s expertise in clinical trial execution, regulatory strategy, and patient engagement makes it an ideal partner for Paradigm as we execute the pivotal Phase III osteoarthritis trial.
“With global capabilities and a strong track record in OA research, Advanced Clinical will support Paradigm in delivering a seamless trial, ensuring regulatory success, and accelerating the development of transformative therapies.”
The company is awaiting ethics approval in Australia. The first trial sites will be activated in Victoria, with up to ten sites across the country.
Recruitment activities are set to begin post-site activation, with the first subject dosing anticipated in the second quarter of 2025.
