Phase 3 Knee OA Trial Recruitment Update
| Stock | Paradigm Biopharmaceuticals Ltd (PAR.ASX) |
|---|---|
| Release Time | 23 Dec 2025, 8:29 a.m. |
| Price Sensitive | Yes |
Paradigm Confirms Progress Toward 25% Recruitment Milestone in Pivotal Phase 3 Trial
- Paradigm has the required number of participants enrolled or randomized to support achievement of the 25% recruitment milestone for the PARA_OA_012 trial
- Screening activity remains strong, with the majority of sites expected to be actively enrolling from the beginning of the new year
- Screening at Moldova and Hong Kong sites to commence in mid-January, further supporting recruitment momentum
Paradigm Biopharmaceuticals Ltd. (ASX: PAR) has provided an update on recruitment progress for its pivotal Phase 3 PARA_OA_012 clinical trial evaluating injectable pentosan polysulfate sodium (iPPS) for the treatment of knee osteoarthritis. The company confirms that it has the required number of participants either enrolled or randomised to support achievement of the 25% recruitment milestone for the trial. Due to the upcoming holiday period and temporary site shutdowns, a number of participants contributing to this milestone are scheduled to commence dosing in the new year. This approach reflects the six-week dosing regimen and the requirement for both Paradigm and its global CRO to ensure participants are not exposed to any risk of missed doses during the holiday shutdown period. Screening activity across the trial remains strong, with a significant pipeline of prospective participants. Paradigm expects the 50% recruitment milestone to be achieved shortly after completion of the 25% dosing milestone, as the majority of activated sites are expected to be actively enrolling from the beginning of the new year. Screening at the Moldova and Hong Kong sites is expected to commence in mid-January, further supporting recruitment momentum. The interim analysis for PARA_OA_012 remains on track for mid-calendar year 2026, with primary endpoint analysis for the full patient cohort expected in Q4 CY2026.
Paradigm expects the 50% recruitment milestone to be achieved shortly after completion of the 25% dosing milestone, as the majority of activated sites are expected to be actively enrolling from the beginning of the new year. Screening at the Moldova and Hong Kong sites is expected to commence in mid-January, further supporting recruitment momentum.