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Protagen AG. (4/28/15). "Press Release: NavigAID SLE – Protagen Zooms into the Micro Cosmos of Autoimmune Disease".

Organisations Organisation Protagen AG
  Group Protagen (Group)
  Organisation 2 BioStrata Ltd.
Products Product NavigAID SLE patient stratification array
  Product 2 Benlysta®
Persons Person Kirschbaum, Bernhard (Merck Serono 200809 Executive VP Research)
  Person 2 Müllner, Stefan (Fundamenta Life-Sciences GmbH 201711 General Manager + Partner before Protagen –201610 CEO)

PROTAGEN AG, a company dedicated to the development of powerful diagnostic tools to address some of the most severe autoimmune diseases, has today launched NavigAID SLE, a patient stratification array, to support Pharma and Biotech companies with their Systemic Lupus Erythematosus (SLE) drug development efforts.

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 allows the separation and definition of patient subgroups and increases the probability of success in SLE therapy and drug development. Worldwide, approximately 5 million patients are affected by this severe autoimmune disease. Recent clinical developments in SLE have focused especially on inhibiting the activation of autoreactive B-cells thereby reducing autoantibody production.

Former Merck Serono Executive and Protagen Board Member, Bernd Kirschbaum explains: “With the exception of Benlysta, approval for novel drugs for SLE therapy is far behind other autoimmune diseases including Rheumatoid Arthritis (RA) and Multiple Sclerosis (MS). One major hurdle may be the observed patient heterogeneity. In order to develop effective and curative therapies it is pivotal to define homogeneous disease subgroups in SLE patients, and the new NavigAID SLE does exactly this.” Stefan Müllner adds, “Our innovative diagnostic technology for the first time separates and defines subgroups in SLE, as such it enables new approaches to successful drug development and should be integrated in any SLE clinical development program.”

About NavigAID SLE

SLE is an autoimmune disease with a range of clinical manifestations and a huge medical and diagnostic need. Yet, with the exception of Benlysta, no new drug has been approved for SLE by the FDA in 50 years, and several hurdles for successful SLE drug development exist.

The Protagen NavigAID SLE was specifically developed to address the critical challenges in the clinical development of novel drugs for SLE with the simple measurement of serum biomarkers. As such, it enables specific differential diagnosis, state-of-the-art disease activity assessment and type-I Interferon signature comparison plus a novel, unique disease stratification approach that will be beneficial to any new SLE clinical program. Furthermore, it has the potential to provide the basis for treatment specific companion diagnostics (CDx).

About Protagen – Diagnostics Differentiated

Protagen AG, headquartered in Dortmund, Germany, specializes in the development of novel diagnostic and companion diagnostic tests to provide better and earlier diagnosis of autoimmune diseases.

Protagen uses its proprietary SeroTag® biomarker platform to identify disease specific autoantibodies and is on target to become the leading provider of autoimmune diagnostic products, specifically targeting diseases with an unmet need for effective diagnostics. With pioneering bioscience techniques, extensive scientific expertise and a broad patent portfolio, Protagen works to develop its own diagnostic pipeline and partners with other organizations to develop and implement new companion diagnostic tools for better personalized treatment strategies.


Dr. Stefan Müllner
T +49 231 9742 6300

Media Enquiries
Dr. Clare Russell
Managing Director
T +44 1223 828200
M +44 7812 343412

Record changed: 2017-04-02


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