Edison Investment Research - Paradigm Biopharmaceuticals (PAR) Paradigm Biopharma - Pivotal Phase III progressing as planned

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Edison Investment Research

Sean Conroy

Paradigm Biopharma - Pivotal Phase III progressing as planned

Paradigm has announced the completion of patient recruitment for stage one (dose selection) of its pivotal Phase III trial, PARA_OA_002, a multi-centre (US/Australia/UK/EU/Canada), two-stage, adaptive, randomised, double-blind, placebo-controlled study to assess injectable pentosan polysulfate (iPPS) in patients with knee osteoarthritis (kOA) pain. Paradigm has efficiently recruited participants for the trial through various initiatives, such as through its partnership with NFL Alumni Health. Management expects stage one to be complete in Q3 CY23, and for stage two to commence with the most effective dose later in H2 CY23. The selected dose will also be used in the initiation of the separate confirmatory Phase III trial in H2 CY23. These events represent key milestones for Paradigm, in our view.

05/07/2023 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

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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 - Pivotal Phase III progressing as planned

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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