PARADIGM ACHIEVES 60% REDUCTION IN OSTEOARTHRITIS PAIN Key Highlights:
• Paradigm is pleased to report that a 60.5% reduction in pain (on average) has been achieved, from an additional 25 patients with osteoarthritis after treatment with the injectable Pentosan Polysulfate Sodium (iPPS). Paradigm has now received data from a total of 100 patients treated by their doctors under the Therapeutic Goods Administration Special Access Scheme (TGA SAS).
• Combining today’s results of 25 patients with the previously reported 75 patients increases the average reduction in pain scores to 52.9%.
• The pain reducing effects of iPPS are considered significantly superior than the typical 15% pain reduction scores reported for opioid treatments for chronic pain in OA of the knee and hip.1
• These patients were treated under a similar dosing regimen as Paradigm’s current 110 patient Phase 2b osteoarthritis randomised double-blind, placebo-controlled, clinical trial, which has completed recruitment and is expected to release results in late Q4 CY2018.
• The results from these 100 patients provides important Real-World Evidence (RWE) data, which can be used in combination with Randomised Controlled Clinical Trials to support product registration for repurposed pharmaceuticals under the 505(b)(2) regulatory pathway.
• Paradigm will continue to report over the coming months on the groups of patients that are currently undergoing treatment from their doctors under the TGS SAS.
• OA is a blockbuster indication, a condition with a significant unmet medical need.
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