Diamyd Medical AB Class B · OMXSTO:DMYD_B
Diamyd Medical AB Class B — Corporate Update (August 2006)
16 slides from Diamyd Medical AB Class B's corporate update, Aug 23, 2006
Slide 1: Reporting of Phase II Type 1 Diabetes Trial
DIAMYD MEDICAL Reporting of Phase II Type 1 Diabetes Trial Presentation at OMX 23 August 2006 Anders Essen-Möller, President & CEO, Diamyd Medical Johnny Ludvigsson, MD, PhD, Professor of Pediatrics, Linköping University ©2006 Diamyd Medical AB All rights reserved
Slide 2: Principal Investigator on Diamyd Type 1 Diabetes Trial
Principal Investigator on Diamyd™ Type 1 Diabetes Trial Johnny Ludvigsson, M.D., Ph.D X Professor of Pediatrics, Div of Pediatrics and Diabetes Research Centre, Linköping University, Sweden X Leading expert in diabetes therapies and active in several immune intervention trials over the past decades
Slide 3: Overview of Type 1 Diabetes Phase II Trial
Overview of Type 1 Diabetes Phase II Trial X 70 patient double-blind placebo–controlled trial in 8 clinical centers X Statistically significant efficacy as measured by C-peptide levels X No drug-related serious adverse events X Therapy is easy to administer and is well-accepted by patients and care
Slide 4: Type 1 Diabetes – Disease with Severe Complications
Type 1 Diabetes – Disease with Severe Complications X Autoimmune disease X Destruction of insulin producing cells X Lack of insulin produces diabetes leading to severe complications and early death. X Saving beta cells can prevent diabetes, lessen severity of the disease, or even cure the disease. ©
Slide 5: Diamyd-GAD Vaccination in Recent Onset Type 1 Diabetes
Diamyd-GAD Vaccination in Recent Onset Type 1 Diabetes Phase II Started Jan 2005 X Randomized, double blind, placebo-controlled clinical trial. X 70 patients with Type 1 diabetes since 0-18 months. X 35 patients in each group received either Diamyd™ 20 microg or placebo subcutaneously at days 1 and
Slide 6: Patient Inclusion criteria
Patient Inclusion criteria X 10 - 18 years of age at diagnosis of Type 1 diabetes and at first vaccination. X Fasting C-peptide 0.1 nmol/l or more at screening. X Positive for GAD65 auto antibodies at screening. X Written informed consent both from patient and both parents. ©2006 Diamyd Medical AB A
Slide 7: Phase II Study Measurements
Phase II Study Measurements Z C-peptide after Sustacal-load (meal-stimulated) Z Fasting C-peptide Z Insulin dose (IU/kg,24 hrs) Z HbA1c levels ©2006 Diamyd Medical AB All rights reserved
Slide 8: Phase II Preliminary Results
Phase II Preliminary Results Z GAD65 treatment group showed higher C-peptide levels after sustacal load at 9 months than the placebo group (p=0.02). Z GAD65 treatment group showed higher C-peptide levels after sustacal load at 15 months than the placebo group (p=0.01). Z No significant differences i
Slide 9: Loss of C-peptide by Area Under the Curve
Loss of C-peptide by Area Under the Curve Diamyd Placebo 0,8 0,7 0,6 0,5 Pmol/ml 0,4 0,3 0,2 0,1 0 3 Months 9 15 Conclusion: Decline in C-peptide levels for placebo group was nearly 2 times greater than for Diamyd™ group. ©2006 Diamyd Medical AB All rights reserved
Slide 10: Change in C-peptide after Sustacal Challenge (9 Months)
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 -0,2 p=0.02 -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 group whe
Slide 11: Change in C-peptide after Sustacal Challenge (15 Months)
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 -0,15 -0,2 Pmol/ml -0,25 -0,3 p=0.01 -0,35 -0,4 -0,45 Conclusion: Over a 2 hour period after a meal, Diamyd™ treatment group’s C-Peptide production declined less than place
Slide 12: 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. ©2006 Diamyd Medical AB All rights reserved
Slide 13: Phase II Summary
Phase II Summary Z GAD 65 has demonstrated efficacy in slowing the decline of C-peptide Levels after sustacal load. Z GAD 65 therapy proposes a novel, first-in-class therapy for slowing the progression of autoimmune Type 1 diabetes. Z GAD 65 offers a compelling therapeutic option for type 1 diabetes
Slide 14: Diamyd Medical Future – Product Development
Diamyd Medical Future – Product Development Z Initiate plan for major Type 1 studies in US and Europe. Jerry Palmer, MD, Univ. of Washington in US will run US trials. Johnny Ludvigsson MD, PhD Linköping University will run European trial. Z Phase III product supply from Protein Sciences. Z Complete
Slide 15: Diamyd Medical Future – Product Positioning
Diamyd Medical Future – Product Positioning Z Develop plan for Diamyd™ product launch Opportunity: Type 1 and autoimmune Type 2 (LADA) indications Licensing, co-development, or launch independently Z Financing options to support Phase 3 trials Potential exercise of warrants by 31 August 2006, Licens
Slide 16: Question and Answer Session
Question and Answer Session ©2006 Diamyd Medical AB All rights reserved