Paradigm Biopharmaceuticals has reached key milestones in its global Phase 3 trial for knee osteoarthritis, activating its first Australian clinical site and enrolling the first patient. With multiple sites in Australia and the US preparing for recruitment, the trial is advancing steadily toward critical data readouts.
- First Australian clinical site activated at Sportsmed Biologic, Melbourne
- First Australian patient consented for Phase 3 knee osteoarthritis trial
- 11 Australian and 48 US sites selected and preparing for activation
- Trial evaluates injectable pentosan polysulfate sodium (iPPS) for knee OA pain
- On track for US patient enrollment and dosing in the coming quarter
Paradigm Advances Phase 3 Knee Osteoarthritis Trial
Paradigm Biopharmaceuticals Ltd (ASX – PAR) has marked a significant operational milestone in its global Phase 3 clinical trial evaluating injectable pentosan polysulfate sodium (iPPS) for knee osteoarthritis. The company announced the activation of its first Australian clinical site at Sportsmed Biologic in Melbourne, led by Dr Philip Bloom, a specialist with extensive experience in osteoarthritis management. This activation is complemented by the consent of the first Australian patient to participate in the trial, signaling the start of patient enrollment in Australia.
Dr Bloom’s involvement is notable given his prior experience treating over 300 patients with iPPS under Australia’s Special Access Scheme, providing valuable insight into both the therapy and the targeted patient population. His leadership at the Melbourne site underscores Paradigm’s commitment to rigorous clinical evaluation and patient care.
Expanding Clinical Footprint Across Australia and the US
Beyond the initial site activation, Paradigm has secured commitments from 11 clinical sites across Australia, all at various stages of start-up and activation. In the United States, the trial’s scale is even broader, with 48 clinical sites selected and preparing for activation under a centralized ethics approval. The company anticipates first patient consent in the US imminently, with randomization and dosing expected to follow in the coming quarter.
This extensive network of sites reflects Paradigm’s strategic approach to enrolling a diverse patient population and generating robust data to support the efficacy and safety of iPPS. The trial itself is a randomized, double-blind, placebo-controlled study designed to evaluate pain reduction and functional improvement in 466 participants with moderate-to-severe knee osteoarthritis.
Trial Design and Regulatory Progress
The PARA_OA_012 trial’s primary endpoint focuses on the change from baseline in average daily pain at Day 112, with secondary endpoints including validated pain and function measures, patient global impression of change, rescue medication use, and structural joint assessments via MRI and X-ray. The study protocol received FDA clearance in November 2024, and Paradigm has since completed the necessary infrastructure setup, including electronic data capture systems, laboratory networks, and manufacturing and labeling of both the investigational product and placebo comparator.
Managing Director Paul Rennie expressed satisfaction with the progress, highlighting the high engagement from clinical investigators and adherence to the company’s timeline. This momentum is crucial as Paradigm moves closer to generating pivotal data that could support regulatory approval and eventual commercialisation of iPPS for knee osteoarthritis.
Looking Ahead
As patient recruitment scales up across Australia and the US, Paradigm is poised to deliver important insights into the potential of iPPS to address a significant unmet medical need. Osteoarthritis affects millions worldwide, and new therapies that can effectively reduce pain and improve joint function are in high demand. The coming months will be critical in assessing the trial’s progress and the therapy’s prospects.
Bottom Line?
With patient enrollment underway and multiple sites activating, Paradigm is on a promising path toward pivotal Phase 3 data for knee osteoarthritis treatment.
Questions in the middle?
- How quickly will US patient enrollment and dosing commence following site activations?
- What interim data might emerge from the trial to indicate early efficacy or safety signals?
- How does iPPS compare to existing osteoarthritis treatments in terms of potential market impact?