Paradigm Biopharmaceuticals Secures US Ethics Approval for Phase 3 Osteoarthritis Trial

Paradigm Biopharmaceuticals ( (AU:PAR) ) has provided an announcement.

Paradigm Biopharmaceuticals has received US centralised ethics approval for its pivotal phase 3 clinical trial, PARA_OA_012, which evaluates the efficacy of iPPS in treating knee osteoarthritis. This approval allows the company to activate up to 55 clinical trial sites across the US, with the first patient enrolment expected in Q3 2025. The trial, which is a randomised, double-blind, placebo-controlled study, aims to assess the efficacy and safety of iPPS in 466 patients. This milestone is significant for Paradigm as it strengthens its global phase 3 program and brings it closer to delivering a first-in-class treatment for knee osteoarthritis, reflecting the company’s commitment to high-quality trials in key healthcare markets.

The most recent analyst rating on (AU:PAR) stock is a Buy with a A$0.80 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 improving patients’ health and quality of life by discovering, developing, and delivering pharmaceutical therapies. The company’s current focus is on developing injectable pentosan polysulfate sodium (iPPS) for treating diseases where inflammation plays a major pathogenic role, such as osteoarthritis and mucopolysaccharidosis.

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Technical Sentiment Signal: Strong Sell

Current Market Cap: A$120.7M

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