Late-stage drug development company Paradigm Biopharmaceuticals (ASX:PAR) has selected Advanced Clinical as its preferred partner at the conclusion of its selection process for the Clinical Research Organisation (CRO) to support its pivotal phase 3 clinical trial.
After thorough analysis and comparison, Advanced Clinical emerged as the optimal partner, demonstrating exceptional capabilities and alignment with Paradigm’s strategic goals for the phase 3 PARA_OA_012 trial.
“We are delighted to partner with Advanced Clinical for our pivotal phase 3 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 on the pivotal phase 3 osteoarthritis trial, Paul Rennie, Managing Director of Paradigm, said.
“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. This partnership represents a critical step forward in our journey to improve the lives of those suffering from osteoarthritis with the treatment of iPPS.”
Next Steps
With Advanced Clinical now onboard as the preferred CRO, Paradigm is focused on the next phase of trial preparation, including site activation and patient recruitment. Paradigm is anticipating centralised ethics approval for Australia to be received shortly, with the first sites to be activated in Victoria and up to 10 sites total across Australia. Following site activation recruitment activities will commence with the first participant dosing anticipated in Q2 CY2025.
About PARA_OA_012
PARA_OA_012 is a randomised, double-blind, placebo-controlled, multi-centre study that will evaluate the dose and treatment effect of injectable pentosan polysulfate sodium (iPPS) in participants with knee OA pain.
The study’s primary objectives focus on pain reduction and functional improvement as measured by validated scales. The trial is expected enrol approximately 466 participants in a 1:1 randomisation design, with an interim analysis planned after the Day 112 pain data from approximately 50% of the total sample size has been collected.
This phase 3 trial builds on the positive outcomes of Paradigm’s previous phase 2 studies, including the PARA_OA_008 trial, which demonstrated significant clinical benefits in pain reduction and improved joint function for up to 12 months in patients treated with iPPS .