Paradigm Biopharma - Potential for disease-modifying kOA treatment
Paradigm has announced day 168 (six-month) data from the PARA_OA_008 trial, which is evaluating injectable pentosan polysulfate sodium (iPPS) as a potentially disease-modifying treatment for knee osteoarthritis (kOA). Highlights from the interim data include: structural changes in several disease features as measured by magnetic resonance imaging (MRI), potential support for disease-modifying OA drug (DMOAD) activity from trends in biomarker data, and persistent positive responses in WOMAC scores. During the second half of CY23, Paradigm intends to discuss with the FDA and EMA a potential regulatory pathway for DMOAD indication labelling; we believe that the outcome, along with clarification on the Phase III development pathway, could represent a significant catalyst for the company.Paradigm Biopharmaceuticals is engaged in the research and development of therapeutic products for human use. Co. patents include: (1) BME patent - the use of the drug Pentosan Polysulphate Sodium (PPS) for treatment of Bone Marrow (o)Edema (BME). This patent is granted in the United States, Australia and New Zealand. (2) Respiratory patent - PPS for treating Allergic Rhinitis, Allergic Asthma and COPD from Glycan Biosciences LLC. This patent is granted in Australia, New Zealand, and China. (3) Exosome patent - is being prosecuted in all major markets
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