Paradigm Biopharmaceuticals (ASX:PAR) will proceed with a phase 3 knee osteoarthritis trial of Zilosul, following a 30-day review by the US Food and Drug Administration of its clinical trial protocol, according to a Thursday filing with the Australian bourse.
The study's primary endpoint is a change from baseline in pain using injectable pentosan polysulfate sodium, with changes in the Patient's Global Impression of Pain, functional assessments at specific time points, and structural changes as secondary endpoints, the filing said.
Patient enrollment will start in the first quarter of next year at 10 Australian clinical trial sites, followed by US sites, as per the filing.
The company's shares tumbled almost 14% in recent Thursday trade.
Price (AUD): $0.50, Change: $-0.08, Percent Change: -13.91%
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