PAR 2.04% 24.0¢ paradigm biopharmaceuticals limited..

Ann: Quarterly Update and Appendix 4C - quarterly, page-3

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  1. 4,436 Posts.
    lightbulb Created with Sketch. 7005
    ...Quarterly, some good outlook points, yes mainly covered in AGM but good to see wrap anyway, good to see ongoing conferences in the background (MPS) continuing....



    OUTLOOK

    • Paradigm expects to complete 100% recruitment in the PARA_OA_008 during 1H 2022.
    The program is recruiting and treating at two sites across Australia with top-line data
    expected Q3 CY2022.

    • Paradigm will present at the WORLD Symposium in San Diego, California, the annual
    research conference focused on new therapies for lysosomal storage diseases such as
    MPS VI. The presentation will be conducted by leading geneticist and principal
    investigator Dr Roberto Giugliani on Paradigm’s phase 2 trial for mucopolysaccharidosis
    type-VI (MPS VI). The Company during the conference will release a MPS VI patient focus
    group study. The study is the largest of its kind in the world and has attracted the interest
    of medical researchers and MPS patient advocacy groups globally.

    • Paradigm recently reported the first participant dosing in Australia in the PARA_OA_002
    clinical trial. Eight sites have been initiated in Australia and are currently screening
    subjects. Initiation of sites in the US continues to ramp up with 65 sites identified in the
    US and AUS to participate in the clinical program. The Company expects to report first
    participant dosing in the US during Q1 CY 2022.

    • The Company expects to continue initiation activities for the PARA_OA_002 clinical study
    sites in the UK and Europe and will update shareholders on key activities as they are
    achieved.

    • The Paradigm Remuneration and Nominations Committee continues its consultation with
    a global executive search firm and meetings with shortlisted candidates with the
    identified experience in the global pharma industry. The market will be notified on
    Identification of the CEO.

    • The peer review publication of the company's Phase 2b study (PARA_005) in knee OA is
    planned to coincide with publication of ongoing PARA_008. Topline data of PARA-005
    have been previously announced in company presentations.

    • An Expanded Access Program protocol (EAP) in the US for re-treatment of Zilosul® is being
    designed following discussions with the participants and their physician who have
    expressed strong interest in a follow-up retreatment program approximately 18 months
    following their initial treatment.
    Last edited by Mozzarc: 31/01/22
 
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