Paradigm Biopharmaceuticals (ASX:PAR) has announced the completion of enrolment in its pivotal Phase 3 trial of Zilosul injectable pentosan polysulfate sodium for knee osteoarthritis, a milestone that moves the company into the next phase of clinical and corporate catalysts.
The company reported that 538 participants have commenced treatment, exceeding the original target of 466 and representing the largest clinical study conducted using its selected dosing regimen of 2 mg per kg administered twice weekly for six weeks.
The multicentre, randomised, double-blind, placebo-controlled PARA_OA_012 study spans 65 clinical sites across Australia, the United States, Hong Kong and Moldova.
The study’s primary endpoint is the change from baseline in Weekly Average Daily Pain score at Day 112. Key secondary endpoints will assess physical function, patient global assessment, responder outcomes and other clinically meaningful measures. The final treated population of 538 is expected to contribute to a robust clinical dataset while preserving the planned timelines and statistical framework.
Paradigm confirmed that the Interim Analysis remains on track for September 2026 and that top-line Phase 3 results are anticipated in the first quarter of calendar year 2027.
Completion of enrolment removes a significant execution risk for the Phase 3 program and allows the company to focus on treatment completion, patient follow-up, and the delivery of upcoming milestones.
Osteoarthritis affects more than 500 million people worldwide and remains a major unmet medical need with treatment options largely focused on symptom management rather than disease modification. Previous clinical studies of Zilosul have shown statistically significant improvements in pain and function and signals of favourable effects on structural and biological markers associated with disease progression.
Paradigm Executive Chairman Paul Rennie said, "Completion of enrolment and commencement of treatment for 538 participants represents a defining milestone for Paradigm and one of the most significant achievements in the company's history.
"Successfully executing a global Phase 3 study across 65 sites and four countries reflects the dedication of our clinical operations team, investigators, study coordinators and, most importantly, the patients who have chosen to participate in this important study. Osteoarthritis remains one of the largest areas of unmet medical need in medicine, affecting hundreds of millions of people worldwide and imposing an enormous burden on patients, healthcare systems and society.
"Importantly, the successful completion of enrolment further de-risks the Phase 3 program and positions Paradigm for a series of significant upcoming milestones. We remain on track for the Interim Analysis expected in September 2026 and top-line Phase 3 results anticipated in the first quarter of 2027."