Six-month Follow-up (day 168) Data
The PARA_OA_008 phase 2 clinical trial will continue to monitor trial participants following treatment through the 6-month and out to 12-month timepoints. The 6-month time point for PARA_OA_008 will provide further data on the duration of effect of iPPS on WOMAC pain and function compared to placebo combined with observations on changes
to the joint structure by MRI of iPPS treated subjects compared to placebo. The secondary and exploratory endpoints at 6-month time point, include:
• changes in one or more synovial fluid biomarkers;
• changes and correlation between synovial fluid, serum, and urine biomarkers and correlation with changes in clinical outcomes;
• changes in WOMAC pain, function, stiffness and quality of life scores;
• MRI changes in the bone and joint; and
• Incidence of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs).
Paradigm expects to report on the 6-month data in Q1 CY2023. Data from this study will be prepared for peer-review and publication with the Company providing an update once timing can be confirmed.
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