Paradigm Biopharmaceuticals (ASX:PAR) has completed enrolment in its pivotal global Phase 3 trial for Zilosul, marking a major milestone as the company shifts its focus toward patient follow-up, interim analysis and the delivery of key clinical data.
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A total of 538 participants have commenced treatment in the PARA_OA_012 study, exceeding the original enrolment target of 466 patients. The increase reflects participants already progressing through screening when the enrolment target was reached, with eligible patients to complete the process.
The randomised, double-blind, placebo-controlled trial is being conducted across 65 clinical sites in Australia, the U.S., Hong Kong, and Moldova. It is evaluating Zilosul (iPPS) as a treatment for pain associated with knee osteoarthritis.
Completion of enrolment removes one of the company’s largest operational milestones and allows attention to shift to treatment completion, patient follow-up, data quality and preparation for upcoming clinical readouts.
An interim analysis outcome is targeted for September. Topline third-phase primary results also remain on track for the first quarter of CY27.
Beyond the pivotal study, Paradigm continued to expand the scientific evidence supporting Zilosul. Phase 2 biomarker findings from the PARA_OA_008 study were presented at the Osteoarthritis Research Society International 2026 World Congress, highlighting biological activity across cartilage degradation, inflammation, and pain pathways.
During the quarter, Paradigm strengthened its balance sheet through a capital raising that generated approximately A$21.38M before costs, comprising a A$14M institutional placement and a A$7.38M share purchase plan.
As at June 3, 2026, Paradigm held cash and cash equivalents of ~A$15.37M. After quarter end, the company received a further A$5.69M through research and development tax incentives and tax refunds, before completing a US$3M drawdown under its convertible note facility, adding ~A$4.6M in capital.
Paradigm said it remains funded through key upcoming milestones, including the Phase 3 interim analysis and top-line results expected in early CY27.
PAR is down -3.03% today.
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