NavigAID SLE separates and defines subgroups in Systemic Lupus Erythematosus (SLE) via the simple measurement of serum biomarkers.
NavigAID SLE enables specific differential diagnosis, disease activity assessment, type-I Interferon signature comparison plus a unique disease stratification approach thereby overcoming heterogeneity and enabling new approaches to successful drug development.
The Protagen SeroTag® process helps to understand complex autoimmune diseases on a molecular basis. Utilizing this diagnostic magnifying glass, Protagen has developed NavigAID SLE, which defines disease subgroups and increases the probability of success in Systemic Lupus Erythematosus (SLE) therapy.
SLE is an autoimmune disease with a range of clinical manifestations. Worldwide, approximately 5 million patients are affected. Recent clinical developments in SLE have focused especially on inhibiting the activation of autoreactive B-cells, thereby reducing autoantibody production.
With the exception of Benlysta, approval for novel drugs for SLE therapy is far behind Rheumatoid Arthritis (RA) and other autoimmune diseases, and several hurdles for successful SLE drug development still exist:
Pathogenesis of SLE is multi-factorial, including genetic, environmental, and hormonal factors
SLE is an extremely complex disease that affects multiple organs and is described by extremely variable clinical profiles
Differences among ethnic groups can be found in disease prevalence, disease activity and clinical manifestations
Due to the remitting and relapsing nature of the disease, those treated with placebos still show significant response rates
The variable clinical presentation is a challenge to apply composite responder indices in clinical trials.
Solving the problem of SLE patient heterogeneity is pivotal for the clinical development of effective and curative therapies. Although significant progress has been made in understanding molecular disease mechanisms, there is still an unmet need for novel diagnostic biomarkers and assays for precise disease characterization, patient stratification and response prediction. The Protagen NavigAID SLE does exactly this and should become part of any SLE clinical development program.
Protagen has also recently released a whitepaper discussing the application of the new NavigAID SLE array for patient stratification and the successful development of companion diagnostics, as well as the principle benefits offered by the technology.