• Participants dosed in pivotal PARA_OA_012 Phase 3 trial of injectable pentosan polysulfate sodium (iPPS)
• Early study start-up focused on site initiation, activation, and MRI quality certification
• Improved screen-failure rate versus previous PARA_OA_002 trial

Paradigm Biopharmaceuticals Ltd (ASX:PAR) has announced that participants have been randomised and dosed in both Australia and the United States in the pivotal PARA_OA_012 Phase 3 clinical trial evaluating injectable pentosan polysulfate sodium (iPPS) for the treatment of pain associated with knee osteoarthritis (kOA). The initial phase of the trial has focused on site initiation and activation, including mandatory imaging certifications, to ensure a high number of sites are ready to recruit before large-scale recruitment begins. As activation nears completion, a suite of patient recruitment initiatives is scheduled to roll out, including Paradigm's own patient connection hub, Hope4OA, and collaborations with Citeline and Medimark. Early screening results show a materially improved screen failure rate compared with the previous PARA_OA_002 study, following constructive discussions with the U.S. FDA to refine the eligibility criteria. Paradigm remains on track to achieve full enrolment of 466 participants in the first half of 2026, with the interim analysis scheduled for mid-2026, a key potential value catalyst for the company.

Paradigm continues to actively manage the PARA_OA_012 study progress, with the option to recruit additional trial sites or regions to maintain momentum and ensure planned timelines remain on track. The company is well positioned to meet its enrolment targets and deliver the interim analysis in mid-2026, a major value inflection point.