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Paradigm Biopharmaceuticals Limited (ASX:PAR)

ALERT: Price-sensitive ASX Announcement for PAR
Current share price for PAR : $0.175 -0.135 (-43.55%)+
Announcement
Release
30 Sep 2025 10:46AM
Price at Release
$0.310
Full Release
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Summary
Paradigm Biopharmaceuticals Limited has announced the initiation and progress of their Phase 3 clinical trial (PARA_OA_012) for the treatment of knee osteoarthritis using injectable pentosan polysulfate sodium (iPPS). The trial is being conducted in both Australia and the United States, with an emphasis on ensuring high-quality imaging data and site readiness before large-scale recruitment. The company has implemented various recruitment initiatives, including their patient connection hub Hope4OA, to facilitate patient enrolment. Early trial data indicate improved screening outcomes due to refined criteria, and full enrolment is expected by the first half of CY2026, with interim analysis planned for mid-CY2026.
Key Points
  • Participants dosed in the pivotal PARA_OA_012 Phase 3 trial of iPPS.
  • Focus on site initiation, activation, and MRI quality certification.
  • All selected sites expected to be activated and recruiting by end of October.
  • Improved screen-failure rate reflecting FDA-guided criteria refinements.
  • Interim analysis expected in mid-CY2026 as a potential value catalyst.
  • PARA_OA_012 trial is a randomized, double-blind, placebo-controlled study.
  • Primary endpoint is change from baseline in average daily pain at Day 112.
  • Early patient screenings familiarise investigators with protocols.
  • Recruitment initiatives include collaboration with Hope4OA, Citeline, and Medimark.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.