Paradigm Biopharmaceuticals Ltd. · ASX:PAR
Paradigm Biopharmaceuticals — 41st Annual J.P. Morgan Healthcare Conference (January 2023)
21 slides from Paradigm Biopharmaceuticals's conference presentation, Jan 11, 2023
Slide 1: Paradigm Presentation at the 41st Annual J.P. Morgan Healthcare Conference
ASX RELEASE 11 January 2023 Paradigm Presentation at the 41st Annual J.P. Morgan Healthcare Conference For personal use only Paradigm Biopharmaceuticals Ltd (ASX:PAR, “Paradigm” or “the Company”), a late-stage drug development company focused on delivering new therapies to address unmet medical need
Slide 2: For further information please contact
FOR FURTHER INFORMATION PLEASE CONTACT: Simon White Director of Investor Relations For personal use only Tel: +61 404 216 467 Paradigm Biopharmaceuticals Ltd. ABN: 94 169 346 963 Level 15, 500 Collins St, Melbourne, VIC, 3000, AUSTRALIA Email: investorrelations@paradigmbiopharma.com
Slide 3: 41st Annual J.P. Morgan Healthcare Conference
For personal use only 41 st Annual J.P. Morgan Healthcare Conference
Slide 4: Disclaimer
For personal use only Paradigm Biopharma JAN 2023 2 Disclaimer This document, together with any information communicated by Paradigm Biopharmaceuticals Ltd ASX:PAR (known as “Paradigm”, “Paradigm Biopharma” or “the Company”), in any presentation or discussion relating to this document (collectively,
Slide 5: About Pentosan polysulfate sodium for subcutaneous use (PPS, iPPS)
For personal use only Paradigm Biopharma JAN 2023 3 About Pentosan polysulfate sodium for subcutaneous use (PPS, iPPS) • PPS is a non-opioid with a 60-year track record treating pain, inflammation, and Paradigm Proven Molecule thrombosis in humans. Paradigm Osteoarthritis (OA) ZILOSUL® Biopharmaceut
Slide 6: Extensive market protection
Paradigm Biopharma JAN 2023 4 4 Extensive market protection For personal use only Exclusive Complex supply molecule Alphavirus • Molecular platform technology and a Heart ? Failure complex trade-secret manufacturing process make it extremely difficult to replicate. Severe OA Arthroplasty Pain • The
Slide 7: Recent Milestones
Paradigm Biopharma JAN 2023 5 Osteoarthritis (OA) For personal use only • IND open for phase 3 clinical trial and Fast Track Designation granted by US FDA. • Actively screening and enrolling participants in US, AU, UK, CAN. • Phase 2 disease modifying OA data accepted for presentation at OARSI World
Slide 8: Lead Clinical Programs
Paradigm Biopharma JAN 2023 6 Lead Clinical Programs For personal use only 2021 2022 2023 2024 2025 2026 OA_002 Pivotal & Confirmatory OA_003 NDA OA_006 Duration of OA_006 effect OA_007 OA Label OA_009 Extension OA_010 MPS I phase 2 Safety and Efficacy MPS VI phase 2 Proposed MPS VI phase 3 002 OA N
Slide 9: Osteoarthritis
For personal use only Paradigm Biopharma 01/04/21 JAN 2023 77 Osteoarthritis OA
Slide 10: Blockbuster market opportunity
For personal use only Paradigm Biopharma JAN 2023 8 Blockbuster People affected by OA in 20203 Knee and Hip (Global) market opportunity 72m+ 69 % of all OA Zilosul® aims to OA patients dissatisfied with current People affected by OA by 20303 meet a significant treatments1 unmet need in osteoarthriti
Slide 11: Phase 2b – PARA_OA_005 Results
Paradigm Biopharma 29/12/20 JAN 2023 99 Phase 2b – PARA_OA_005 Results For personal use only PHASE 2B CONTROLLED STUDY CONDUCTED TO SUPPORT PARADIGM’S PHASE 3 OA PROGRAM Pain Reduction (KOOS) KOOS Function (ADL) 1 Adjusted mean change from baseline to days 11, 25, 39, 53, 81, 109, and 165. (N=112, 1
Slide 12: Phase 2b – PARA_OA_005 Results
Paradigm Biopharma 29/12/20 JAN 2023 10 Phase 2b – PARA_OA_005 Results For personal use only • iPPS 2mg/kg SC twice weekly vs placebo. • iPPS showed significantly reduced serum levels of cartilage degradation biomarkers COMP, ADAMTS-5 & urine levels of CTX-II. • iPPS showed significant reduction in
Slide 13: OA current and future clinical trials
For personal use only Paradigm Biopharma JAN 2023 11 PARA_OA_ 002 PARA_OA_ 006 • Phase 2/3 dose vs treatment effect of iPPS for • Observational extension study from 002, knee OA pain/function, compared to placebo. continued safety/efficacy. • First stage (n=468) dose identification, • Further 34-wee
Slide 14: Osteoarthritis - Global Phase PARA_OA_002 Global Progress
Paradigm Biopharma 01/04/21 JAN 2023 1212 Osteoarthritis - Global Phase 3 PARA_OA_002 Global Progress For personal use only Harmonised clinical protocol to achieve simultaneous registration in key jurisdictions United States • Fast Track Designation • 50+ sites activated • Enrolling participants Aus
Slide 15: Exploring the potential of iPPS as a disease modifying OA drug (DMOAD)
Paradigm Biopharma 01/04/21 JAN 2023 1313 EXPLORING THE POTENTIAL OF iPPS AS A For personal use only DISEASE MODIFYING OA DRUG (DMOAD) PARA_OA_008 • Biomarker study assessing change from baseline in multiple objective measures associated with disease progression of OA. • 60 participants received iPP
Slide 16: Day 56 top-line results – changes in synovial fluid biomarkers
For personal use only Paradigm Biopharma JAN 2023 14 DAY 56 TOP-LINE RESULTS – CHANGES IN SYNOVIAL FLUID BIOMARKERS In all cases, the synovial biomarker changes in iPPS-treated subjects at day 56 were favourable compared to placebo control. Synovial iPPS compared to Biomarker Biomarker placebo Funct
Slide 17: Day 56 top-line results – changes in WOMAC pain & function from baseline
For personal use only Paradigm Biopharma JAN 2023 15 DAY 56 TOP-LINE RESULTS – CHANGES IN WOMAC PAIN & FUNCTION FROM BASELINE • Participants in the study were asked to provide baseline pain scores using the WOMAC Osteoarthritis Index. • iPPS treatment showed statistically significant improvements at
Slide 18: Mucopolysaccharidosis
For personal use only Paradigm Biopharma 01/04/21 JAN 2023 1616 Mucopolysaccharidosis MPS
Slide 19: Mucopolysaccharidosis (MPS)
Paradigm Biopharma JAN 2023 17 Mucopolysaccharidosis (MPS) For personal use only MPS I - Australia Phase 2 asset in rare disease associated with inflammation & ongoing musculoskeletal pain: iPPS has FDA & EMA orphan designation for MPS • Open-label trial SC dosing subjects weekly for 12 weeks, then
Slide 20: Summary
Paradigm Biopharma JAN 2023 18 Summary For personal use only • Actively screening and enrolling participants globally in P3 Knee OA clinical trial. Phase 3 asset in • Obtained regulatory feedback for a harmonised clinical protocol to blockbuster achieve simultaneous registration in key jurisdictions
Slide 21: For more information please visit
For personal use only Paradigm Biopharma JAN 2023 19 For more information please visit: paradigmbiopharma.com Or email: investorrelations@paradigmbiopharma.com
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