Paradigm Biopharmaceuticals (ASX:PAR) has announced its plan to submit a revised protocol to the U.S. FDA by October 2024 for its Phase 3 clinical trial. This trial focuses on the injectable pentosan polysulfate sodium (iPPS) for osteoarthritis treatment. The company anticipates beginning patient enrolment in early 2025.
Paradigm Biopharmaceuticals is advancing with a revised Phase 3 clinical trial protocol for iPPS, addressing FDA feedback to improve trial efficiency. Patient enrolment is expected to commence in early 2025. The company is in the process of selecting a CRO from four shortlisted global contenders. Governance updates include Dr. Donna Skerrett focusing on her CMO duties, while the board ensures independent oversight. The company demonstrates investor confidence through board share purchases and explores shareholder rewards if PARO options expire. Paradigm remains dedicated to developing treatments for inflammation-driven diseases.
The revised protocol incorporates feedback from the FDA aimed at enhancing patient convenience, improving retention, and reducing trial costs. We remain confident in our progress and strategic direction.