16 slides from Paradigm Biopharmaceuticals's technical presentation, Dec 18, 2018
Slide 1: Phase 2b OA/BMEL Clinical Trial Results Presentation
Phase 2b OA/BMEL Clinical Trial Results Presentation 18 December 2018
Slide 2: Disclaimer
Disclaimer This document, together with any information communicated by Paradigm Biopharmaceuticals Ltd (known as “Paradigm”, “Paradigm Biopharma” or “the Company”), in any presentation or discussion relating to this document (collectively, “Information”) is confidential, and has been prepared by th
Slide 3: Corporate Overview
Corporate Overview Financial Information § Paradigm Biopharmaceuticals Ltd is an ASX-listed Share price (13-December-2018) A$1.32 biotechnology company focused on repurposing Number of shares 139.8m pentosan polysulfate sodium (PPS), an FDA-approved drug that has a long track record of safely treati
Slide 4: Osteoarthritis Pain
Osteoarthritis Pain Osteoarthritis – Facts and Figures § Most common form of joint disease and the leading cause of disability for people greater than 65 years of age1 § OA is a progressive disease strongly correlated with bone marrow edema lesions (BMEL), affecting the entire joint, including synov
Slide 5: Knee OA Clinical Trial Design Strategy
Phase 2b Knee OA Clinical Trial Design Strategy § Paradigm Clinical team – extensive clinical trial experience with pain as a primary endpoint. § Ultimate objective of clinical development: To succeed in Phase 3 for successful marketing registration in Australia and abroad. § Previous clinical trial
Slide 6: Knee OA – Clinical Trial Design
Phase 2b Knee OA – Clinical Trial Design The Phase 2b, placebo controlled clinical trial was conducted to evaluate the effects of injectable Pentosan Polysulfate sodium (iPPS) on the treatment of pain in subjects with osteoarthritis of the knee and concurrent subchondral bone marrow edema lesions Tr
Slide 7: Knee OA – Subject Population
Phase 2b Knee OA – Subject Population Key Inclusion Criteria § Subjects with a clinical diagnosis of osteoarthritis in one or both knees and a radiographic diagnosis of knee osteoarthritis showing a Kellgren-Lawrence score 2, 3 or 4 (i.e. moderate to severe Knee OA), and baseline pain score of NRS 4
Slide 8: Key outcomes from Osteoarthritis Clinical Trials
Key outcomes from Osteoarthritis Clinical Trials The main goals of clinicians, patients and regulatory authorities of a phase 2 clinical trial for OA § Safety § Clinically meaningful reduction in pain >50% and statistical significance over placebo § Looking for other signs of meaningful clinical imp
Slide 9: Top Line Report: Primary End point at Day 53
Top Line Report: Primary End point at Day 53 § Primary Endpoint of “Change in KOOS pain from baseline” met, with statistical and clinical significance compared with Baseline § Distribution of subjects in the NRS stratum of 4-6 was 70% and subjects in the NRS stratum of 7-8 was 30% of the total study
Slide 10: iPPS Treatment Meets its Primary End Point
iPPS Treatment Meets its Primary End Point >50% Reduction from Baseline in pain as measured in KOOS Pain Score at Day 53 (NRS: 4-6 stratum) 60 50 P<0.026 Percentage of Subjects 40 30 20 10 0 Placebo iPPS § iPPS treatment is statistically significant compared to placebo (Chi-square analysis) § iPPS t
Slide 11: KOOS Pain Subscale – Clinically Meaningful Pain Reduction of >50% from Baseline
KOOS Pain Subscale – Clinically Meaningful Pain Reduction of >50% from Baseline KOOS Pain Subscale – NRS Stratification: 4-6 Treatment period P<0.026 P<0.021 § Statistically greater proportions of subjects with >50% reduction in pain from Baseline after iPPS as measured by KOOS Pain subscale (Chi-sq
Slide 12: NRS Pain Score – Clinically Meaningful Pain Reduction of >50% from Baseline
NRS Pain Score – Clinically Meaningful Pain Reduction of >50% from Baseline NRS Pain Score – NRS Stratification: 4-6 Treatment period P<0.0008 P<0.02 § Statistically greater proportions of subjects with >50% reduction in pain from Baseline after iPPS as measured by NRS pain score (Chi-square analysi
Slide 13: Phase 2b OA Results – Conclusions
Phase 2b OA Results – Conclusions § Clinical trial met the primary endpoint - Change in KOOS pain score from baseline at Day 53 § Clinically meaningful and statistically significant results between iPPS and Placebo in the total population (p=0.031) and highly clinically meaningful and highly statist
Slide 14: Knee OA Results
Phase 2b Knee OA Results Key Outcome In the total study population, iPPS achieved a safe, well tolerated, clinically meaningful, statistically significant result over placebo as demonstrated by higher number of subjects with >50% reduction in KOOS pain score from baseline. NRS strata 4-6, produced h
Slide 15: 2019 Objectives and Catalysts
2019 Objectives and Catalysts Paradigm is well positioned to execute many valuable milestones throughout CY19 ü File IND for Phase 3 trial in OA/BMEL with the possibility of being granted “fast track status” for the Phase 3 trial ü Ross River Phase 2a trial results release – Q1CY2019 ü CY2019 file I
Slide 16: Contacts
Contacts Office Level 2, 517 Flinders Lane, Melbourne, VIC, 3000 info@paradigmbiopharma.com CORPORATE ENQUIRIES: Managing Director & CEO Paul Rennie - prennie@paradigmbiopharma.com INVESTOR RELATIONS: Dirk van Dissel - Adelaide Equity Partners Ltd E: dvandissel@adelaideequity.com.au D: +61 408 326 3