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Stage 1 of the PARA_OA_002 phase 3 clinical trial completes recruitment, with final participants in the process of completing protocol-mandated screening and randomization. The trial is on track to conclude dose selection after all stage 1 participants reach 84 days post initial treatment.
Paradigm is on course in its recruitment initiatives, having activated 120 clinical trial sites across 7 countries. The timeline for Paradigm’s New Drug Application (NDA) with the US FDA remains on track.
The independent Data Monitoring Committee gives the green light, based on two formal safety reviews, to proceed with the pivotal Phase 3 clinical trial, without any modifications.
iPPS demonstrated long-lasting improvements in pain relief, joint function, and cartilage volume in a canine osteoarthritis model at a time point equivalent to 3 years in humans.
Disease progression was stabilized, and serum biomarker levels favorably regulated at both 8 and 26 weeks in osteoarthritic dogs, supporting iPPS's mechanism of action.
The canine study data supports further clinical development of Paradigm's phase 3 trials and will be presented to the US and EU regulatory authorities to determine requirements for a disease modifying OA drug (DMOAD) label.
Day 168 data from Paradigm's phase 2 PARA_OA_008 clinical trial shows injectable pentosan polysulfate sodium (iPPS) may slow disease progression in knee osteoarthritis (OA).
iPPS demonstrates a 21% improvement in mean cartilage loss score, significant reductions in bone marrow edema lesions, and reduction of marginal osteophytes compared to placebo.
Positive clinical responses in WOMAC pain, function, stiffness, and overall WOMAC scores have been observed, with the results to be presented to the FDA and EMA for potential disease-modifying OA drug (DMOAD) label approval.