FDA greenlights Paradigm's trial

Paradigm Biopharmaceuticals (ASX:PAR) has received clearance from the U.S. FDA to proceed with its Phase 3 clinical trial targeting knee osteoarthritis. This trial will evaluate the efficacy of a 2mg/kg twice-weekly dose of injectable pentosan polysulfate sodium. Patient enrollment is slated to begin in early 2025.

Paradigm's strategic trial outlook

Paradigm Biopharmaceuticals' recent FDA clearance paves the way for a significant Phase 3 trial aimed at treating knee osteoarthritis. The trial will begin with up to 10 sites in Australia and later expand to the US, involving approximately 466 participants. Focused on assessing pain and structural changes, the trial's design includes an interim analysis for early efficacy. Paradigm aims to address unmet medical needs with Zilosul®, fostering partnerships and funding opportunities. Continuous updates will support stakeholder engagement throughout the trial's progress.

Executive insights on clinical progress

The FDA's feedback has been incorporated into our trial design, enhancing the focus on structural changes. This milestone allows us to engage potential partners for support and funding.