Big news from Paradigm Biopharmaceuticals – they’ve officially chosen Advanced Clinical as their Clinical Research Organisation (CRO) for the upcoming Phase 3 clinical trial (PARA_OA_012). This is a major step forward in their mission to develop Pentosan Polysulfate Sodium (PPS) as a potential treatment for knee osteoarthritis (OA) pain.
Why Advanced Clinical?
Paradigm didn’t rush this decision. They went through a rigorous selection process, reviewing proposals from seven top-tier global CROs before narrowing it down to four finalists. After carefully assessing expertise, global reach, and operational efficiency, Advanced Clinical stood out as the perfect partner.
What makes them special?
- A strong track record in osteoarthritis research
- Expertise in regulatory strategy and patient engagement
- A global presence across North America, Europe, and the Asia-Pacific region
- A commitment to delivering high-quality clinical trials efficiently
What’s Next?
With Advanced Clinical on board, Paradigm is moving full speed ahead with trial preparations. The PARA_OA_012 study will enrol around 466 participants across up to 10 sites in Australia, starting with Victoria. The first patient dosing is targeted for Q2 2025, pending final approvals.
Paradigm’s Managing Director, Paul Rennie, expressed his confidence in the partnership, saying:
“Advanced Clinical’s expertise in trial execution and patient engagement makes them the ideal partner as we push forward with our pivotal Phase 3 osteoarthritis trial. This partnership is a crucial step in bringing new treatment options to those suffering from OA.”
Why This Matters
For the millions of people suffering from knee osteoarthritis, there’s an urgent need for better, non-opioid treatment options. Paradigm’s PPS therapy has already shown promise, and this Phase 3 trial is a key step toward potential regulatory approval. With a world-class CRO in their corner, they’re well-positioned to execute a smooth and successful trial.
Exciting times ahead—stay tuned for updates as Paradigm moves closer to changing the game in osteoarthritis treatment!
