Paradigm Biopharmaceuticals (ASX:PAR) has reached a milestone in its global PARA_OA_012 Phase 3 clinical trial, confirming that 50% of the required participants have now been dosed.
The achievement keeps the late-stage drug development company on track for a highly anticipated interim analysis, with results expected to be delivered in August 2026.
The study is investigating the efficacy of injectable pentosan polysulfate sodium in treating osteoarthritis.
With a total target enrolment of 466 participants across Australia, the United States, Europe, and Asia, the trial focuses on the change in the weekly average of daily pain as its primary endpoint.
Secondary assessments include improvements in physical function, structural imaging outcomes, and overall safety.
Participants are closely monitored through a Day 112 assessment period.
Following the evaluations, the interim dataset will undergo rigorous data cleaning and independent statistical analysis by a data monitoring committee, a process projected to take four to six weeks.
Paradigm has designed the Phase 3 trial to align closely with its PARA_OA_008 study, utilising a comparable patient population and dosing regimen.
By maintaining consistency in trial design while incorporating key learnings from previous dose-ranging studies, the company aims to mitigate development risks and ensure comparability across its clinical program.