The ASX biotechs with secured FDA clearances in 2024, and others looking likely | Daily Telegraph
Paradigm Biopharma (ASXAR)In April, Paradigm submitted key documents to the FDA for review, aiming to advance its pivotal Phase 3 clinical trial of lead drug, injectable pentosan polysulfate sodium (iPPS/Zilosul) to treat osteoarthritis (OA).Often referred to as degenerative joint disease or ‘wear and tear’ arthritis, OA stands out as the most common form of this condition.PAR aims to minimise the disease's impact by improving the functional mobility, preserving the joint structure, and reducing pain of affected individuals.The company is developing injectable pentosan polysulfate sodium (iPPS/Zilosul) and Mucopolysaccharidosis, where inflammation significantly contributes to the disease process.A Phase 2 trial demonstrated one course of iPPS can provide 12-month pain relief and improved function in knee OA sufferers. The same clinical trial also demonstrated improvement in cartilage volume and thickness at six months following treatment compared to placebo.
research reports and media, page-4164
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