Paradigm Biopharmaceuticals has appointed Advanced Clinical as the Clinical Research Organisation for its critical Phase 3 trial targeting knee osteoarthritis pain, setting the stage for patient recruitment and dosing in Q2 2025.
- Advanced Clinical selected as preferred CRO for PARA_OA_012 Phase 3 trial
- Trial to enrol approximately 466 participants with knee osteoarthritis pain
- First participant dosing targeted for Q2 calendar year 2025
- Advanced Clinical brings global reach and osteoarthritis expertise
- Site activation and patient recruitment underway, starting in Victoria, Australia
Paradigm’s Strategic CRO Partnership
Paradigm Biopharmaceuticals Ltd (ASX:PAR) has announced the selection of Advanced Clinical as its preferred Clinical Research Organisation (CRO) to lead the execution of its pivotal Phase 3 clinical trial, PARA_OA_012. This trial is a critical milestone in Paradigm’s development of injectable pentosan polysulfate sodium (iPPS) for knee osteoarthritis (OA) pain, a condition with significant unmet medical needs.
After a rigorous evaluation process involving seven global CROs, Paradigm shortlisted four candidates before ultimately choosing Advanced Clinical. The decision was driven by Advanced Clinical’s proven expertise in osteoarthritis research, operational excellence, and patient-centric trial management. This partnership underscores Paradigm’s commitment to ensuring high-quality data and regulatory compliance as it advances toward potential market approval.
Trial Design and Execution Plans
The PARA_OA_012 study is designed as a randomised, double-blind, placebo-controlled, multi-centre trial enrolling approximately 466 participants. It aims to evaluate the efficacy and safety of iPPS in reducing knee OA pain and improving joint function. The trial will employ a 1:1 randomisation and includes an interim analysis after collecting Day 112 pain data from half of the participants.
Paradigm is preparing for site activation and patient recruitment, with initial sites to be established in Victoria and up to 10 sites across Australia. The company anticipates centralised ethics approval shortly, targeting the first participant dosing in the second quarter of 2025. This timeline reflects Paradigm’s confidence in Advanced Clinical’s operational capabilities and global reach.
Advanced Clinical’s Role and Capabilities
Founded in 1994 and headquartered in Chicago, Advanced Clinical offers a blend of global scale and personalised service. Its extensive experience in musculoskeletal disorders and osteoarthritis trials positions it well to manage the complexities of PARA_OA_012. The CRO’s strengths include streamlined site activation, innovative patient recruitment and retention strategies, and robust data management supported by advanced technology platforms.
Paul Rennie, Managing Director of Paradigm, highlighted the strategic importance of this partnership, noting Advanced Clinical’s regulatory expertise and patient engagement approach as key factors that will help accelerate the trial’s progress and eventual regulatory success.
Context Within Paradigm’s Development Pipeline
This Phase 3 trial builds on encouraging Phase 2 results from the PARA_OA_008 study, which demonstrated significant pain reduction and functional improvements lasting up to 12 months. Success in PARA_OA_012 could pave the way for iPPS to become a transformative therapy for osteoarthritis, addressing a large patient population with limited effective treatment options.
Paradigm’s broader pipeline also includes Phase 2 development of iPPS for mucopolysaccharidosis, reflecting the company’s focus on inflammatory diseases where iPPS’s anti-inflammatory and tissue regenerative properties may offer substantial benefits.
Bottom Line?
With Advanced Clinical onboard, Paradigm accelerates toward a pivotal trial that could reshape osteoarthritis treatment.
Questions in the middle?
- How quickly will patient recruitment progress across Australian sites and potentially beyond?
- What regulatory hurdles remain before full trial commencement and eventual approval?
- How might interim data from PARA_OA_012 influence Paradigm’s strategic and commercial plans?