Edison Investment Research - Paradigm Biopharmaceuticals (PAR) Paradigm Biopharma - Durable responses observed for kOA

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Edison Investment Research

Sean Conroy

Paradigm Biopharma - Durable responses observed for kOA

Paradigm has announced positive day-365 data from its Phase II trial (PARA_OA_008) assessing injectable pentosan polysulfate (iPPS) as a potentially disease-modifying treatment for knee osteoarthritis (kOA). The latest data show durable responses based on measures of pain and function, while confirming the company will be pursuing an iPPS (2mg/kg) twice-weekly regimen for six weeks across all of its clinical programmes for kOA. Based on this update, Paradigm now plans to proceed with a Provisional Approval application to the Therapeutic Goods Administration (TGA, the Australian regulatory authority). The day-365 data are encouraging for iPPS as a potential treatment for kOA, in our view, adding to the company’s data package to support discussions with regulatory authorities and potential partners. We note that Paradigm is awaiting full analysis of MRI data from this trial, and plans to share it in the near term.

17/10/2023 1 EN

Underlying

Paradigm Biopharmaceuticals

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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AU000000PAR5 Australian Securities Exchange Australia

Provider

Edison Investment Research

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.

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Analysts

Sean Conroy

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Paradigm Biopharma - Durable responses observed for kOA

Paradigm Biopharma - Termination of coverage

Paradigm Biopharma - Q1 results recap iPPS progress in OA & MPS

Paradigm Biopharma - Disease modifying properties in iPPS Phase II

Manx Financial Group - Termination of coverage

musicMagpie - Termination of coverage

Topps Tiles - Accelerating growth through Q125

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