Diamyd Medical AB Class B · OMXSTO:DMYD_B

Diamyd Medical AB Class B — EASD 2006

14 slides from Diamyd Medical AB Class B's conference presentation, September 2006

  1. Slide 1: The Swedish GAD-vaccination Trial: Phase II Safety and Efficacy Trial with Diamyd

    The Swedish GAD-vaccination Trial: Outcomes of a Phase II Safety and Efficacy Trial with Diamyd™ for Preservation of Beta Cell Function in Children with Type 1 Diabetes. J.Ludvigsson, R.Casas, O. Vaarala, G. Forsander, S.A.Ivarsson, C.Johansson, A.Lindh, N.O.Nilsson, J.Åman, E.Örtqvist, J.A.Robertso

  2. Slide 2: Background

    Background „ Immune interventions at onset of diabetes in children so far have given – no or limited effect – too serious side effects „ GAD can prevent diabetes in experimental animals „ GAD vaccination (20 microgram) in LADA patients saved beta cell function (Agardh et al 2005) Study: D/P2/04/3 Lu

  3. Slide 3: Design of the Study

    Design of the Study „ Randomized, double blind, placebo-controlled clinical trial. „ Either placebo or 20 microg GAD (Diamyd™) sc at Days 1 and 30. „ Sustacal loads with determination of C-peptide ( Delphia) - 0,30,60,90,120 minutes - day 1 and at 3 months, 9 months, 15 months - will continue at 21

  4. Slide 4: Subjects and Inclusion Criteria

    Subjects and Inclusion Criteria „ 70 patients, male and female, with Type 1 diabetes „ 10 - 18 years at diagnosis of Type 1 diabetes and at first Diamyd vaccination. Disease duration 0-18 months at intervention. „ Fasting-C-peptide 0.1 nmol/l or more at screening. „ Positive for GAD65 auto-antibodie

  5. Slide 5: Baseline Data

    Baseline Data GAD (Diamyd™) Placebo Means ± SD Means ± SD Fasting s/C-peptide at screening, pmol/ml 0.337 ± 0.158 0.336 ± 0.178 C-peptide AUC Day 1, pmol/ml*2hour 1.239 ± 0.569 1.414 ± 0.867 Age, years 13.8 ± 2.3 12.8 ± 1.9 Duration of diabetes, (months) at intervention 9.9 ± 5.3 8.8 ± 5.4 GADA, Uni

  6. Slide 6: Change in C-Peptide after Sustacal Challenge

    Change from Day 1 in C-Peptide after Sustacal Challenge; 9 Months Diamyd Minutes after meal Placebo 0 0 30 60 90 120 -0.05 -0.1 Pmol/ml -0.15 p=0.02 (AUC) -0.2 -0.25 -0.3 -0.35 Conclusion: Over a 2 hour period after a meal, Diamyd™ treatment group’s C-peptide production declined less than placebo gr

  7. Slide 7: Change in C-Peptide after Sustacal Challenge

    Change from Day 1 in C-Peptide after Sustacal Challenge; 15 Months Diamyd Minutes after meal Placebo 0 0 30 60 90 120 -0.05 -0.1 Pmol/ml -0.15 -0.2 -0.25 p=0.01 (AUC) -0.3 -0.35 -0.4 -0.45 Conclusion: Over a 2 hour period after a meal, Diamyd™ treatment group’s C-Peptide production declined less tha

  8. Slide 8: Change in C-Peptide AUC, Month 15

    Change in C-Peptide, AUC Change in C-peptide, AUC, Month 3 to 15 Month 3 Month 9 Month 15 Diamyd 0 Placebo -0.1 -0.2 pmol/ml*2hour -0.3 -0.4 -0.5 -0.6 -0.7 -0.8 Study: D/P2/04/3 Ludvigsson et al ©2006 Diamyd Medical AB, All rights reserved

  9. Slide 9: No decline of Max C-Peptide when GAD given to patients with <3 months disease duration

    No decline of Max C-Peptide when GAD given to patients with <3 months disease duration Change from Day 1, Maximum C-peptide, Disease duration at intervention 0-<3 months Diamyd Month 3 Month 9 Month 15 Placebo 0.2 0 pmol/ml -0.2 -0.4 -0.6 -0.8 Study: D/P2/04/3 Ludvigsson et al ©2006 Diamyd Medical A

  10. Slide 10: No decline of C-Peptide AUC when GAD given to patients with <3 months disease duration

    No decline of C-Peptide AUC when GAD given to patients with <3 months disease duration Change from Day 1, C-peptide AUC, Disease duration at intervention 0-<3 months Diamyd Month 3 Month 9 Month 15 Placebo 0.4 0.2 pmol/ml*2hour 0 -0.2 -0.4 -0.6 -0.8 -1 Study: D/P2/04/3 Ludvigsson et al ©2006 Diamyd

  11. Slide 11: Less C-peptide decline also in patients with 3-6 months disease duration

    Less C-peptide decline also in patients treated with 3-6 months disease duration Change from Day 1, Maximum C-peptide, Disease duration at intervention 3-<6 mon Diamyd Month 3 Month 9 Month 15 Placebo 0.1 0 -0.1 pmol/ml -0.2 -0.3 -0.4 -0.5 -0.6 -0.7 Ludvigsson et al Study: D/P2/04/3 ©2006 Diamyd Med

  12. Slide 12: Less increase of insulin dose in the GAD intervention group

    Less increase of insulin dose in the GAD intervention group Insulin Dose, Percentage Change from Month 1 Diamyd 60% Placebo 50% 40% 30% 20% 10% 0% Month 3 Month 9 Month 15 Study: D/P2/04/3 ©2006 Diamyd Medical AB, All rights reserved

  13. Slide 13: Adverse Events

    Adverse Events Diamyd™ Placebo Connective tissue 3 6 Nervous system 3 3 Immune System 2 1 Blood 1 1 Serious AE 1 3 There were no treatment-related Serious Adverse Events. Study: D/P2/04/3 Ludvigsson et al ©2006 Diamyd Medical AB, All rights reserved

  14. Slide 14: Conclusions

    Conclusions „ GAD 65 has demonstrated efficacy in slowing the decline of C-peptide Levels after sustacal load. „ GAD 65 therapy proposes a novel, first-in-class therapy for slowing the progression of autoimmune Type 1 diabetes. „ GAD 65 offers a compelling therapeutic option for type 1 diabetes due

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