PAR Completes Enrolment in Pivotal Phase 3 Osteoarthritis Trial
Key points
- Enrolment completed on schedule in Paradigm's pivotal Phase 3 PARA_OA_012 study
- Enrolment completion removes a significant execution milestone
- Interim Analysis remains on track for September 2026
Full summary
Paradigm Biopharmaceuticals Ltd. (ASX: PAR) has successfully completed enrolment in its pivotal Phase 3 clinical trial, PARA_OA_012, evaluating Zilosul® (injectable pentosan polysulfate sodium) for the treatment of pain associated with knee osteoarthritis. The study, which is being conducted across 65 clinical sites in Australia, the United States, Hong Kong, and Moldova, has enrolled 538 participants, exceeding the original target of 466 participants. The completion of enrolment removes a significant execution risk and positions Paradigm for upcoming clinical milestones, including an Interim Analysis expected in September 2026 and top-line Phase 3 results anticipated in Q1 CY2027. Paradigm will host an investor webinar on June 18, 2026, to provide an update on the Phase 3 clinical program and upcoming milestones.
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