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Paradigm Biopharmaceuticals Limited (ASX:PAR)

ALERT: Price-sensitive ASX Announcement for PAR
Current share price for PAR : $0.165 0.015 (10%)+
Announcement
Release
15 Jun 2026 9:11AM
Price at Release
$0.150
Full Release
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Summary
Paradigm Biopharmaceuticals Ltd. has successfully completed enrolment for its pivotal Phase 3 clinical trial, PARA_OA_012, which evaluates the use of Zilosul® (injectable pentosan polysulfate sodium) for the treatment of knee osteoarthritis pain. The study enrolled 538 participants, exceeding the initial target, and is being conducted across 65 clinical sites internationally. This trial is designed to assess the efficacy and safety of Zilosul® as a non-opioid treatment option and constitutes Paradigm's largest and most advanced clinical development program to date. The completion of enrolment is a significant milestone, with interim analysis set for September 2026 and final results expected in the first quarter of 2027.
Key Points
  • Paradigm Biopharmaceuticals Ltd. completes enrolment for Phase 3 PARA_OA_012 trial.
  • The trial evaluates Zilosul® for knee osteoarthritis pain treatment.
  • 538 participants enrolled, exceeding the original target of 466.
  • The Phase 3 study is multicentre, randomised, double-blind, and placebo-controlled.
  • The trial's primary endpoint is the change in Weekly Average Daily Pain score at Day 112.
  • Interim analysis scheduled for September 2026.
  • Top-line Phase 3 results expected in Q1 2027.
  • Paradigm conducting the study across 65 sites in Australia, USA, Hong Kong, and Moldova.
  • Zilosul® aims to be a non-opioid treatment option for knee osteoarthritis.
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.