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Paradigm Clears Key Safety Milestone and Expands Sites in Phase 3 Osteoarthritis Trial

Story Highlights
  • Paradigm’s Phase 3 knee osteoarthritis trial will continue after an independent safety board cleared the first 20 percent of dosed patients.
  • New clinical sites in Moldova are being activated to speed final enrolment, keeping the trial on track for full dosing and an interim analysis in 2026.
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Paradigm Clears Key Safety Milestone and Expands Sites in Phase 3 Osteoarthritis Trial

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An update from Paradigm Biopharmaceuticals ( (AU:PAR) ) is now available.

Paradigm Biopharmaceuticals said its pivotal Phase 3 PARA_OA_012 trial of injectable pentosan polysulfate sodium for knee osteoarthritis will continue as planned after an independent Data Safety Monitoring Board completed a scheduled review of safety data from roughly the first 20% of dosed participants. The positive safety readout supports ongoing recruitment toward a target of about 466 patients and maintains the integrity of the late-stage program.

To accelerate enrolment in the final phase of the trial, Paradigm has activated its first study site in Moldova, with two additional sites in the country expected shortly, leveraging the region’s experienced investigators and efficient recruitment pathways. With global enrolment progressing at a strong pace, the company expects to complete 100% enrolment and dosing in the current quarter and remains on track for an interim efficacy analysis around August 2026, a key milestone for regulatory evaluation and stakeholders monitoring Paradigm’s progress in knee osteoarthritis.

The most recent analyst rating on (AU:PAR) stock is a Buy with a A$0.65 price target. To see the full list of analyst forecasts on Paradigm Biopharmaceuticals stock, see the AU:PAR Stock Forecast page.

More about Paradigm Biopharmaceuticals

Paradigm Biopharmaceuticals Ltd is a late-stage drug development company focused on discovering, developing and delivering pharmaceutical therapies to improve patients’ health and quality of life. The company is currently developing injectable pentosan polysulfate sodium (iPPS) for inflammatory conditions such as osteoarthritis, now in Phase 3, and mucopolysaccharidosis, in Phase 2, targeting indications where anti-inflammatory and tissue regenerative properties are needed.

Average Trading Volume: 1,282,834

Technical Sentiment Signal: Sell

Current Market Cap: A$85.84M

See more data about PAR stock on TipRanks’ Stock Analysis page.

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