Trial progress
Enrolment is complete. The focus now shifts to two major milestones: the interim analysis and Zilosul®’s pivotal Phase 3 top-line results
Enrolment complete
The Phase 3 study closed recruitment with 538 participants randomised across 65 sites in Australia, the United States, Hong Kong and Moldova, above the original target of 466.
Database lock
Data cleaning, biometrics review and independent statistical analysis are being completed so the dataset can be locked ahead of the interim review.
Interim analysis
An independent Data Safety Monitoring Board reviews the first half of participants to reach the relevant assessment milestone.
Topline results
The primary endpoint: change from baseline in weekly average daily pain at Day 112, measured against placebo.
Timing is indicative and subject to change. Clinical trial outcomes cannot be predicted.
Our approach: Smarter Development. Greater Impact.
Most new medicines are invented from scratch. We start with drugs already proven safe in people, then develop them for new conditions.
A more efficient development pathway
With an established body of human safety and clinical data, Paradigm can leverage prior development work rather than starting from first principles, reducing the time, cost and execution risk typically associated with bringing a novel molecule into late-stage development.1
A more direct path to clinical outcomes
By building on established clinical and safety experience, Paradigm can focus development on the studies that matter most, creating a more efficient path to late-stage clinical outcomes and, ultimately, potential patient access.2
Built on established human experience
iPPS entered development with an existing body of human safety and clinical experience. This allowed Paradigm to build its development programme from an established clinical foundation rather than starting with first-in-human studies.
Established, scalable supply
iPPS is supported by an established manufacturing pathway with existing commercial-scale capability. This provides Paradigm with a strong foundation for scalability, quality and continuity of supply as the program advances toward potential commercialisation.
1. Compared to developing a brand-new drug from scratch. 2. In certain circumstances and subject to regulatory requirements.
How it works →Zilosul® (iPPS)
Injectable PPS for knee osteoarthritis
Paradigm's lead program is evaluating injectable pentosan polysulfate sodium (iPPS) as a potential disease-modifying, non-opioid treatment for knee osteoarthritis.
The global Phase 3 clinical program follows a Phase 2 program that measured:
- Pain
- Physical function
- Molecular Biomarkers
- MRI and X-ray Outcomes
- Durability to 12 months
Supported by FDA Fast Track designation granted in 2022, the program is among the most advanced clinical development programs investigating a novel therapy for knee osteoarthritis. Phase 2 findings and supporting data.
Zilosul® is an investigational treatment. It is not approved for general prescription in any market.
Investment highlights
Proven Science. Real Progress.
Injectable pentosan polysulfate sodium is in a pivotal Phase 3 trial, PARA_OA_012, supported by FDA Fast Track designation granted in April 2022.
Large Market Opportunity.
Targeting knee osteoarthritis, a condition affecting over 500 million people globally (GBD 2019). Paradigm's Phase 3 was conducted across 57 clinical sites across four countries to address this significant global health burden.
Patient-Centered Solutions.
A non-opioid, subcutaneous injectable in development for people with moderate to severe knee osteoarthritis pain.
Experienced Leadership.
A team that has taken the clinical development of iPPS from founding in 2014 to a fully enrolled Phase 3, with 538 participants against an original target of 466.
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