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Paradigm Biopharma (ASX:PAR) has officially kicked off its final-stage Phase 3 trial using injectable pentosan polysulfate sodium (iPPS) to treat patients with osteoarthritis (OA) in their knee joints, with randomised participants having now been dosed both at home in Australia and across the sea in the U.S.
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However, a larger-scale recruitment campaign is also in the works, with dosed patients so far considered early patients. Paradigm is busy expanding the number of sites participating in the trial so as to cast the widest possible net; the company expects this process to wrap up by late October.
To that end, the company has also established its own trial-specific website called ‘Hope4OA.’ Also highlighted by PAR on Tuesday was that after feedback from the FDA on earlier criteria, the company is now seeing patients boast an improved collective screening failure rate (this iteration of the P3 trial is called PARA_OA_O12).
“The early site start-up focused on comprehensive site initiation and imaging certification requirements so that, when targeted recruitment initiatives commence, every centre can screen and enrol at scale,” PAR MD Paul Rennie said.
“With nearly all sites expected to be activated and recruiting by the end of October, and additional sites under consideration by our team, we are well positioned to meet our enrolment targets and deliver the interim analysis in mid-2026, a major value inflection point for the company.”
PAR last traded at 31.5cps today.
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