Paradigm Biopharmaceuticals (ASX:PAR) has confirmed that it has achieved approximately 25% of target recruitment in its pivotal Phase 3 PARA_OA_012 clinical trial, evaluating injectable pentosan polysulfate sodium for knee osteoarthritis.
The milestone reflects participants who have either been enrolled or randomised, with some scheduled to commence dosing in the new year due to the upcoming holiday period and temporary site shutdowns.
The six-week dosing regimen and careful management with the company's global CRO are intended to maintain protocol compliance and trial integrity.
Screening activity remains robust, supported by new site openings in Moldova and Hong Kong in mid-January and a targeted patient-outreach initiative in Australia that has generated over 13,000 website visits and approximately 1,000 clinical site referrals.
Paradigm expects the 50% recruitment milestone to follow shortly after, keeping the trial on track for its interim analysis in mid-2026 and primary endpoint evaluation in Q4 2026.
Managing Director Paul Rennie emphasised the company's commitment to participant safety and data quality and wished stakeholders a safe holiday period while highlighting the exciting year ahead for the trial.