• 50% of patients now dosed in the global PARA_OA_012 Phase 3 study
• Interim dataset on schedule for independent statistical analysis in August 2026
• Phase 3 study design closely aligns with successful PARA_OA_008 trial

Paradigm Biopharmaceuticals Ltd. (ASX: PAR) has announced that 50% enrolment in the global Phase 3 PARA_OA_012 clinical trial has now been achieved, with dosing of the final participants required for inclusion in the interim analysis dataset having commenced. Participants are followed from first dosing through the Day 112 assessment period, and the interim dataset will then undergo data cleaning and independent data monitoring committee (DMC) statistical analysis, which is expected to take approximately four to six weeks. Based on the current study timeline, Paradigm expects the interim analysis results to be delivered in August 2026. The PARA_OA_012 study is designed to enrol 466 participants globally, with patients randomised to receive injectable pentosan polysulfate sodium (iPPS) or placebo. The primary endpoint of the study is the change in weekly average of daily pain at Day 112, with secondary endpoints including improvements in physical function, imaging-based structural outcomes, and safety assessments. The PARA_OA_012 Phase 3 trial has been designed to closely align with Paradigm's earlier PARA_OA_008 study, which demonstrated clinically meaningful improvements in pain and function. The two studies utilise a comparable patient population, the same dosing regimen of iPPS, and similar study duration and endpoints. Importantly, the PARA_OA_012 protocol also incorporates key learnings generated across Paradigm's earlier clinical studies, including the use of weekly average of daily pain recordings as the primary pain endpoint, which is intended to improve sensitivity in detecting treatment effects and manage placebo response, a recognised challenge in osteoarthritis trials.

Paradigm will continue to update the market as patients progress through the Day 112 follow-up period and the study advances toward the planned interim analysis in August 2026.