Paradigm Biopharma Doses Patients in US and Australia, Eyes Mid-2026 Interim Analysis

Phase 3 Trial Progresses Across Two Continents

Paradigm Biopharmaceuticals Ltd (ASX, PAR) has reached a significant milestone in its pivotal Phase 3 clinical trial evaluating injectable pentosan polysulfate sodium (iPPS) for knee osteoarthritis. Participants have now been dosed in both the United States and Australia, marking the transition from initial site preparations to active patient recruitment.

The PARA_OA_012 trial, designed to assess the efficacy and safety of iPPS in 466 participants with moderate-to-severe knee osteoarthritis, has focused its early phase on rigorous site initiation and MRI quality certification. This deliberate approach ensures that all participating centers meet high standards for imaging data, a critical component for assessing structural joint changes.

Recruitment Strategy and Regulatory Refinements

With nearly all sites expected to be activated and recruiting by the end of October, Paradigm is ramping up patient enrolment efforts. Central to this is the company’s Hope4OA patient connection hub, which provides accessible information and direct links for potential participants. Complementing this are digital campaigns and outreach programs run by US-based Citeline and Australian Medimark, designed to identify and engage eligible patients efficiently.

Importantly, early screening data indicates a materially improved screen-failure rate compared to the previous PARA_OA_002 study. This improvement follows constructive discussions with the US Food and Drug Administration (FDA), which guided targeted adjustments to the trial’s eligibility criteria, enhancing patient inclusion without compromising scientific rigor.

Looking Ahead to Interim Analysis

Paradigm remains on track to complete full enrolment in the first half of calendar year 2026. The trial’s interim analysis, a key potential value catalyst, is scheduled for mid-2026 once 50% of participants reach Day 112 of treatment. This analysis will provide early insights into the drug’s efficacy and safety profile, potentially shaping the company’s clinical and commercial trajectory.

Managing Director Paul Rennie highlighted the significance of the milestone, emphasizing the company’s methodical approach to site activation and recruitment readiness. He noted that additional sites and regions are under consideration to maintain momentum and meet enrolment targets.

As Paradigm advances this late-stage program, the biotech sector and investors alike will be watching closely for the interim results that could validate iPPS as a novel treatment option for knee osteoarthritis, a condition with substantial unmet medical need.