Paradigm Biopharmaceuticals Ltd. announce top-line data from the Day 168 (6-month) time point in the PARA_OA_008 study exploring the disease modifying potential of iPPS. Data received at Day 168 analysed by independent clinical research organizations and key opinion leaders in osteo and rheumatoid arthritis, demonstrates iPPS is not only having a durable response on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, function and stiffness scores, but also showing multiple signals of slowing or halting the OA disease progression through structural biomarkers identified by MRI and improvements of key molecular biomarkers associated with cartilage degradation. Data from PARA_OA_008 confirms a continuation of positive clinical outcomes from Day 56 through to Day 168 in WOMAC pain, function, and stiffness.

Despite the study not initially being powered to demonstrate significance, several time points reached statistical significance for the twice-weekly iPPS-treated group compared to placebo. Trends or statistically significant differences in several serum, urine, and synovial fluid biomarkers of osteoarthritis progression were observed through Day 168 in iPPS-treated groups, reinforcing the disease-modifying potential of iPPS. New data includes the semi- quantitative analysis of structural markers of OA progression with the comparison of MRI at Day 168 compared to baseline scores established from the screening MRI images.

Positive signals for iPPS-treated subjects compared to placebo were observed (including for cartilage loss and bone marrow edema lesions) indicating a potential slowing of the disease process. All trends, results and signals in all tests and biomarkers indicated that iPPS is beneficial for treating both the symptoms and diseases progression of knee OA.