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Paradigm Biopharmaceuticals (ASX: PAR) has completed enrolment in its pivotal Phase 3 clinical trial evaluating Zilosul for the treatment of pain associated with knee osteoarthritis, marking a major milestone for the late-stage drug developer.
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Some 538 participants have started treatment, exceeding the original enrolment target of 466 patients and creating what the company says is the largest clinical study conducted using its selected dosing regimen.
The completion of enrolment removes a significant execution risk from the Phase 3 program and allows the company to focus on treatment completion, patient follow-up and the delivery of upcoming clinical milestones.
The randomised, double-blind, placebo-controlled trial is being conducted across 65 clinical sites in Australia, the United States, Hong Kong, and Moldova. The study is evaluating injectable pentosan polysulfate sodium (iPPS), marketed by Paradigm as Zilosul, as a potential treatment for knee osteoarthritis pain.
The trial’s primary endpoint will measure changes in weekly average daily pain scores at Day 112, while secondary endpoints will assess physical function, patient global assessment and other clinically meaningful treatment outcomes.
Paradigm confirmed its previously flagged interim analysis remains on track for September. The assessment will be based on the first 50% of participants reaching the relevant study milestone and is independent of the enrolment completion. Top-line Phase 3 results are still expected during the first quarter of CY27.
Osteoarthritis affects more than 500M globally and remains one of the leading causes of disability. Paradigm believes there is a “significant unmet need for non-opioid treatments capable of delivering durable improvements in pain and function.”
The company said previous studies of Zilosul had demonstrated statistically significant improvements in pain and function, with the Phase 3 trial to confirm those findings in a pivotal registration-focused setting.
With enrolment now complete, investors will be watching a series of upcoming catalysts, including the interim analysis in September, an independent safety review of interim data and the release of top-line Phase 3 results in early CY27.
PAR is up more than +6.5% on the market today, last trading at $0.16/sh.
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