Systemic Lupus Erythematosus (SLE)
Systemic Lupus Erythematosus (SLE) is clinically and serologically the most diverse systemic autoimmune disease and is currently incurable. The characteristics of SLE are similar to general immune dysregulation and include the:
- production of autoantibodies
- deposition of immune complexes in tissues
- excessive activation of the complement system
The ‘Great Imitator’
SLE often mimics other diseases leading to misdiagnosis by even the most experienced rheumatologists. The disease spectrum ranges from subtle symptoms through to life-threatening organ failure. Tissue damage mostly occurs in the heart, joints, skin, lungs, blood vessels, liver, kidneys and nervous system.
The heterogeneous presentation of symptoms and the unpredictable nature of disease development make SLE extremely challenging for investigators and physicians. The lack of reliable and specific biomarkers for SLE has both restrained the development of new therapeutics and impacted on the effective clinical management of SLE patients.
New diagnostic tools for SLE
Misdiagnosis of SLE is partly due to unpredictable flares and remissions. The diagnostic criteria developed by the American College of Rheumatology are complex, as the disease is heterogeneous and affects multiple tissues. Currently, no single test exists that is sensitive and specific enough to function as a reliable diagnostic and prognostic indicator.
The established laboratory tests for the diagnosis and monitoring of SLE detect anti-nuclear antibodies and anti-extractable nuclear antigen antibodies. However, many consider these immunological markers as not robust enough for reliable diagnosis.
At Protagen, we have focused on the identification of more specific biomarkers by detecting SLE-specific autoantibody-signatures in patient serum. This promising strategy aims to improve the diagnostic value of autoantibody testing in the diagnosis of SLE, allowing for early identification and classification of SLE patients, enabling better therapeutic strategies, response prediction and disease management.
Improving the therapeutic pipeline
The current focus of SLE treatment is symptom control, while an effective cure is still missing. The lack of sensitive and specific biomarkers to date has impeded the evaluation of new SLE therapeutics in clinical trials. Sadly, we have experienced a gap of over 50 years in which only one drug for SLE treatment has been approved (BenlystaTM, 2011). The reluctance to invest in clinical trials for SLE therapeutics is partly based on the lack of diagnostic tools available to determine drug efficacy with sufficient confidence.
Our proprietary discovery platform enables the identification of autoantibody-signatures for developing sensitive and specific diagnostic tools for SLE. Our platform can also be applied to the co-development of companion diagnostic tests alongside drug discovery programs, providing significant opportunities for our industry partners to develop novel medicines that effectively treat patient subsets with high efficacy.