Paradigm closer to phase III clinical trial with appointment of preferred CRO

Paradigm Biopharmaceuticals has selected Advanced Clinical as the preferred clinical research organisation for the phase III trial for PARA_OA_012.

Paradigm has Advanced Clinical, which has a proven track record in osteoarthritis research, as its preferred CRO for the PARA_OA_012 phase III trial. Pic: Getty Images.

• Paradigm Biopharmaceuticals has appointed Advanced Clinical as its preferred CRO for the PARA_OA_012 phase III trial

• Advanced Clinical has expertise in clinical trial execution, regulatory strategy, and patient engagement

• Company now expects to start dosing participants in Phase III trial from Q2 2025

Special Report: Paradigm Biopharmaceuticals continues to edge closer towards starting the pivotal phase III trial for its knee osteoarthritis treatment after selecting Advanced Clinical as its preferred clinical research organisation.

Advanced Clinical has a proven track record in osteoarthritis research, offering strong therapeutic expertise, global reach, operational excellence and a patient-centric approach to trial execution.

Paradigm Biopharmaceuticals (ASX:PAR) intends to enrol ~466 participants for the phase III trial of PARA_OA_012, its repurposed anti-inflammatory drug pentosan polysulfate sodium (aka PPS, aka Zilosul), to treat OA.

With the selection of Advanced Clinical following an extensive evaluation process involving seven global CROs with expertise in OA clinical research, the company is now preparing for site activation and patient recruitment with the goal of dosing the first participant in Q2 2025.

“We are delighted to partner with Advanced Clinical for our pivotal phase III clinical trial, PARA_OA_012,” managing director Paul Rennie said.

“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 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.

“This partnership represents a critical step forward in our journey to improve the lives of those suffering from osteoarthritis with the treatment of iPPS.”

Phase III trial

In 2024, Paradigm determined the optimal dose of PAR_OA_012 (iPPS) for the phase III trial and had its trial protocol approved by the FDA.

The trial aims to demonstrate improvement in pain and function with subcutaneous injections of iPPS compared with subcutaneous injections of placebo in participants with knee OA pain.

Paradigm said duration of the study will be up to 64 weeks with treatment duration six weeks.

The phase III primary endpoint is the change in knee pain from baseline at day 112, measured by the weekly average daily pain score (0-10 scale).

Key secondary endpoints include knee pain, function, stiffness, quality of life and rescue medication use through to day 365.

Based on positive phase II trial results and FDA guidance PAR also elevated structural improvements —measured via MRI and X-ray — from exploratory to secondary endpoints in the phase III trial.

The Phase II data had demonstrated reductions in bone marrow lesion size, favourable biomarker changes, and increases in cartilage thickness, suggesting iPPS’s potential impact on structural aspects of OA.

This article was developed in collaboration with Paradigm Biopharmaceuticals, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

Originally published as Paradigm closer to phase III clinical trial with appointment of preferred CRO