Paradigm Biopharmaceuticals has taken a significant step forward in its osteoarthritis research program by selecting Advanced Clinical as the clinical research organization (CRO) to oversee its pivotal Phase III trial, PARA_OA_012. The partnership emerged following a comprehensive evaluation of seven global CROs, with Advanced Clinical distinguished by its strategic alignment and specialized capabilities in osteoarthritis research.
The upcoming Phase III trial will evaluate injectable pentosan polysulfate sodium (iPPS) for knee osteoarthritis pain through a rigorous double-blind, multi-center, placebo-controlled study. The trial design includes a planned enrollment of 466 subjects, with a strategic interim analysis scheduled after day 112 using pain data from approximately half of the participants.
Trial Design and Scientific Foundation
The PARA_OA_012 study builds upon encouraging results from previous Phase II investigations, particularly the PARA_OA_008 trial, which demonstrated significant pain reduction and improved joint function in patients treated with iPPS. These benefits were observed to persist for up to 12 months, establishing a strong foundation for the Phase III program.
Paul Rennie, Managing Director of Paradigm Biopharmaceuticals, expressed enthusiasm about the collaboration: "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."
Implementation Timeline and Site Activation
The trial's operational phase is set to commence following pending ethics approval in Australia. Initial site activation will begin in Victoria, with plans to expand to up to ten sites across the country. The company anticipates dosing the first subject in the second quarter of 2025, marking a crucial milestone in the development of this potential therapeutic option for osteoarthritis patients.
Strategic Significance
This partnership represents a critical advancement in addressing the significant unmet need in osteoarthritis treatment. The selection of Advanced Clinical, following their standout performance among four shortlisted CROs, positions the trial for optimal execution and data quality. Their proven expertise in osteoarthritis research and comprehensive clinical trial management capabilities align well with the study's objectives and complexity.
