Paradigm Biopharmaceuticals Limited

The announcement reports the activation of a new clinical trial site in Hong Kong, with patient screening commenced, as the study approaches the 50% recruitment milestone required to trigger an interim analysis. Three additional sites in Moldova are expected to be activated in coming weeks. No efficacy or endpoint results have been reported as the trial is still in the enrolment phase.

50% of the planned 466 participants have now been dosed in the global Phase 3 PARA_OA_012 trial evaluating injectable pentosan polysulfate sodium (iPPS). The final participants required for the interim analysis dataset have commenced dosing and will be followed through a Day 112 assessment period. Interim analysis results are expected in August 2026, representing the first efficacy data readout from the Phase 3 program.

50% of 466 planned participants have been dosed in Phase 3 PARA_OA_012 trial, with interim analysis results expected in August 2026 as previously anticipated.