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Bendavia Slides
- 1. Stealth Peptides Leading Mitochondrial Therapeutics
- 2. Mitochondria Origin Mitochondria primer Origins of mitochondria oProkaryotic cells including bacteria oEukaryotic cells Stealth Peptides Slide 2
- 3. Mitochondria Function Mitochondria oThe organelle that produces energy in cells, often termed the “powerhouse of cells” Mitochondria produce energy or ATP using energy from food Primary source of ROS, initiates apoptosis or cellular death Stealth Peptides Slide 3
- 4. Continuum of Mitochondrial Dysfunction Disease Progression Progression of Disease Healthy Aging or Risk Factors (Smoking and Obesity) Chronic Diseases (CHF and CKD) Genetic Diseases Acute Ischemia, Inflammation, and Death Stealth Peptides ATP ROS ROS ATP ROS ATP ATP ROS Cell Dysfunction and Death Mitochondria Apoptosis No ATP Nucleus Slide 4
- 5. Mitochondria Role in Disease Diseased mitochondria produce excess ROS and lack ATP stores oVicious cycle of disease progression Heart failure Autism Orphan mitochondrial diseases Inflammation and sepsis Neurodegeneration Diabetes Ophthalmology Kidney disease Stealth Peptides Slide 5
- 6. Mitochondria Therapeutic Hurdles Challenges to treating mitochondria o Cellular and outer mitochondrial membrane penetration o Reduced membrane potential in disease o Mitochondrial toxicity Critical need for therapies to overcome these hurdles Stealth Peptides Slide 6
- 7. Bendavia First-in-Class Mitochondrial Targeted Compound Targets cardiolipin, found exclusively in the inner mitochondrial membrane oRestores ATP oPrevents the formation of ROS No apparent effect in healthy mitochondria Ongoing and planned Phase 2 clinical trials oACS study, led by Dr. Michael Gibson oCKD study, led by Dr. Stephen Textor oDME study, led by Dr. Jeffrey Heier Stealth Peptides Slide 7
- 8. Bendavia Therapeutic Potential Renal disease Orphan mitochondrial diseases Heart failure Atherosclerosis Cardiovascular disease Stealth Peptides Skeletal muscle disorders Dysfunctional Mitochondria Metabolic and diabetic diseases Ophthalmology Neurodegeneration Slide 8
- 9. Bendavia Therapeutic Potential Renal disease Mitochondrial diseases Heart failure Atherosclerosis Cardiovascular disease Stealth Peptides Skeletal muscle disorders Dysfunctional Mitochondria Metabolic and diabetic diseases Ophthalmology Neurodegeneration Slide 9
- 10. Chronic Kidney Disease Restores Renal Function in Animal Model Eirin et al. ASN 2011 Stealth Peptides Slide 10
- 11. Bendavia Therapeutic Potential Renal disease Mitochondrial diseases Heart failure Atherosclerosis Cardiovascular disease Stealth Peptides Skeletal muscle disorders Dysfunctional Mitochondria Metabolic and diabetic diseases Ophthalmology Neurodegeneration Slide 11
- 12. Aging Restores Muscle Function in Animal Model Improves Maximal ATP Production In Age Improves Endurance in Age 1200 Control Bendavia 1000 800 p <0.05 600 400 Endurance Capacity Maximal ATP Production 1200 1000 800 600 400 200 200 0 5 months 27 months 0 Marcinek et al. Aging Cell 2013 Control Bendavia Treatment Age Stealth Peptides p <0.05 No apparent effect of Bendavia on normal muscle function Slide 12
- 13. Bendavia Therapeutic Potential Renal disease Mitochondrial diseases Heart failure Atherosclerosis Cardiovascular disease Stealth Peptides Skeletal muscle disorders Dysfunctional Mitochondria Metabolic and diabetic diseases Ophthalmology & Diabetes Neurodegeneration Slide 13
- 14. Diabetic Vision Loss Reversed with Bendavia in Animal Model Normal Diet Diabetic Diet Plus Streptozotocin (STZ) 0.45 Spatial Frequency (c/d) Spatial Frequency (c/d) 0.45 0.40 0.35 p<0.05 0.30 Normal Diet + Vehicle Diabetic diet/STZ+ Vehicle Diabetic diet/STZ+ Bendavia 0.25 0.00 STZ 0 4 Study Drug 8 12 16 Week 20 24 28 0.40 0.35 Normal Diet + Vehicle Normal Diet + Bendavia 0.30 0.25 0.00 Study Drug 0 4 8 12 16 Week 20 24 28 No apparent effect of Bendavia on blood glucose or body weight Alam et al. ADA 2012 Stealth Peptides Slide 14
- 15. Summary Mitochondria and Bendavia Everyone has mitochondrial disease oThe continuum from aging to genetic mitochondrial diseases The continuum of mitochondrial dysfunction features increased ROS and decreased ATP Bendavia appears to restore ATP levels and prevents ROS formation, without affecting healthy mitochondria oMore than 100-peer reviewed papers and abstracts oMore than 300 patients and volunteers of clinical experience with Bendavia No apparent effect in normal, healthy mitochondria Stealth Peptides Stealth Peptides Slide 15