Paradigm Advances Phase 3 Knee Osteoarthritis Trial with US Ethics Approval
Paradigm Biopharmaceuticals has secured centralised US ethics approval for its pivotal Phase 3 trial of injectable pentosan polysulfate sodium (iPPS) targeting moderate to severe knee osteoarthritis, setting the stage for patient enrolment in Q3 2025.
- Centralised US ethics approval obtained for PARA_OA_012 Phase 3 trial
- Up to 55 US clinical sites planned with many preparing for start-up
- First US patient enrolment expected in Q3 2025
- Trial to enrol 466 patients with moderate to severe knee osteoarthritis
- Randomised, double-blind, placebo-controlled design with multiple efficacy endpoints
Paradigm Secures Key Regulatory Milestone
Paradigm Biopharmaceuticals Ltd (ASX: PAR) has achieved a significant step forward in its global clinical development program by receiving centralised ethics approval in the United States for its pivotal Phase 3 trial, PARA_OA_012. This approval, granted by a central institutional review board, streamlines the regulatory process by allowing multiple US clinical sites to operate under a single ethics clearance, accelerating trial initiation.
Expanding Clinical Footprint Across the US
The PARA_OA_012 trial is designed to evaluate the safety and efficacy of injectable pentosan polysulfate sodium (iPPS) in 466 patients suffering from moderate to severe knee osteoarthritis. Paradigm plans to activate up to 55 clinical sites across the US, with many already preparing for trial start-up activities. The company remains on track to enrol its first US patient in the third quarter of 2025, marking a critical milestone in the trial’s timeline.
Robust Trial Design with Comprehensive Endpoints
This randomised, double-blind, placebo-controlled study will primarily assess changes in average daily pain scores at Day 112. Secondary endpoints include well-established measures such as WOMAC pain and function scores, Patient Global Impression of Change, rescue medication use, and structural assessments via MRI and X-ray. These comprehensive endpoints aim to capture both symptomatic relief and potential disease-modifying effects of iPPS.
Global Momentum and Strategic Positioning
Paradigm’s US ethics approval follows prior clearances from the US FDA and Australian ethics committees, underscoring the company’s methodical approach to advancing iPPS through late-stage development. Managing Director Paul Rennie highlighted the milestone as a testament to the strength of Paradigm’s data and the rigour of its clinical program, emphasizing the potential impact on millions affected by knee osteoarthritis.
Looking Ahead
With trial sites gearing up and patient recruitment imminent, Paradigm is poised to deliver critical data that could reshape treatment options for knee osteoarthritis. The company’s continued updates on trial progress will be closely watched by investors and the medical community alike, as the Phase 3 results will be pivotal in determining iPPS’s future commercial prospects.
Bottom Line?
Paradigm’s US ethics approval unlocks a crucial phase in its quest to bring a novel osteoarthritis treatment to market.
Questions in the middle?
- How quickly will Paradigm achieve full patient enrolment across US and Australian sites?
- What interim data might emerge to validate iPPS’s efficacy before trial completion?
- How will Paradigm position iPPS in a competitive osteoarthritis treatment landscape post-trial?
