Fighting autoimmune disease The need for a personalized approach 1 2 Autoimmune disease takes many forms, with varying levels of severity The prevalence of autoimmune disease is widespread and significant Disease is initiated when the body incorrectly mounts an immune response against its own tissues 100 Billion 1 IN 6 AMERICANS SUFFER FROM AUTOIMMUNE DISEASE IN ANNUAL HEALTHCARE COSTS VS Globa la u Connective Tissue une disease m di im to tics nos ag Central Nervous System $1 18) Internal Organs li on IN ANNUAL HEALTHCARE COSTS FOR HEART DISEASE & STROKE 1 IN 13 AMERICANS SUFFER FROM HEART DISEASE 20 B il AUTOIMMUNE DISEASE AFFECTS A RANGE OF BIOLOGICAL SYSTEMS AND HAVE FLUCTUATING PATTERNS OF ACTIVITY AND REMISSION 200 Billion ma rket (e st te a im d VS Over 80 different forms of autoimmune disease • Rheumatoid Arthritis (RA) • Systemic Lupus Erythematosus (SLE) • Ankylosing Spondylitis (AS) • Systemic Sclerosis (SSc) • Multiple Sclerosis (MS) • Neuromyelitis Optica (NMO) • Addison's disease • Celiac disease IN ANNUAL HEALTHCARE COSTS 1 IN 33 AMERICANS SUFFER FROM A FORM OF CANCER 4 Overlapping symptoms make an accurate diagnosis difficult Symptom complexity Advanced screening techniques can boost the power of diagnostics (Dx) Developing better biomarkers using the world’s largest human protein library Joint pain Impaired vision Limb paralysis Pulmonary fibrosis Blindness Ulcers on finger tips Myocarditis Joint stiffness Skin rash Cognitive impairment Fatigue Nephritis Numbness Loss of bladder control Seizure Hardened skin Symptom areas Systemic Lupus Erythematosus Systemic Sclerosis Rheumatoid Arthritis Neuromyelitis Optica Multiple Sclerosis Ankylosing Spondylitis 5 57 Billion Diagnostic tools that can unravel this complexity will improve treatment success 180,000 14,000 CLONES 7,000 GENES PROTEINS and applying SeroTag® to identify and differentiate diseases SeroTag® 3 • Dermatomyositis • Graves' disease • Hashimoto's thyroiditis • Myasthenia gravis • Pernicious anemia • Reactive arthritis • Sjogren syndrome • Type I diabetes • ... B I DWU E R D S C SE D F R D F R E D SWE D F D E R F T MB E D F S R EQ F G E OR G O L T A R G R Y P G E T R T V N H T L R Z T C L C Z B Y O U H V U V U S S S I R G P H I D G T ROU I S T E F J H Z T G I T I S R J U I T Z U SWE D S U I U Z O I KMY FM I K Z Z A F T F C N O E H N R Z G H G S S G T D H D U D I C F G C D S O Z T E P E T E R P E I D D E G D D S D S E Novel, proprietary biomarkers are found to: • Specifically identify diseases earlier • Enable monitoring of progression and prognosis • Improve disease management Dx: deciphering complex and overlapping symptoms for a more specific and accurate diagnosis 6 This approach can also be applied to improve targeted drug development Companion Diagnostics (CDx) can help to identify patient subgroups using disease-specific biomarkers One size does not fit all ONLY 50% OF PATIENTS RESPOND TO DRUGS FOR RHEUMATOID ARTHRITIS DRUG A ONLY 40% OF PATIENTS RESPOND TO DRUGS FOR CARDIAC ARRYTHMIAS DRUG B ONLY 20% OF PATIENTS RESPOND TO DRUGS FOR CANCER Clinicians have to prescribe the perceived best drug, often with limited diagnostics DRUG D DRUG C CDx can be developed alongside a new drug CLINICAL TRIAL PHASES I–III CDx DEVELOPMENT DISCOVERY, OPTIMIZATION, VALIDATION + CDx DRUG A 7 CDx: benefiting all stakeholders, from patients and clinicians, to payors and pharma Diagnostics differentiated Complex symptoms can make an autoimmune disease diagnosis challenging Identification of novel biomarkers can help differentiate disease types 50% of patients do not benefit from their prescribed medication CDx allow for relevant patient stratification and personalized treatment Drug response varies hugely between individual patients Better Dx enable identification of disease stages and prescription of relevant drugs The combination of Dx and CDx facilitates a better understanding of autoimmune disease and its progression, improves the chances of early diagnosis and ensures the right patient gets the right treatment. Source material Autoimmune Statistics. The American Autoimmune Related Diseases Association (AARDA). http://www.aarda.org/autoimmune-information/autoimmune-statistics Spear, B. B., Heath-Chiozzi, M. & Huff, J. Clinical application of pharmacogenetics. Trends Mol. Med. 7, 201–204 (2001). Copyright © 2014 Protagen AG, Dortmund, Germany Protagen AG Otto-Hahn-Str. 15 44227 Dortmund Germany +49 231 9742 6300 info@protagen.com
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