PRECISESADS, a European project to search for new treatments for systemic autoimmune diseases

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PRECISESADS is a European collaborative project within the Innovative Medicines Initiative (IMI ) participated with 23 research centers and five companies from 12 European countries. The ultimate goal is to find innovative diagnostic technology to relate systemic autoimmune disease (SAD) to detectable changes in individual molecular signatures

On February 20th and 21st will take place at the first meeting of the participants of PRECISESADS at the headquarters of the company UCB Pharma , Brussels .

Systemic autoimmune diseases (SAD)

Connective tissue diseases (CTD) or systemic autoimmune diseases (SADs) as they are known today are a group of chronic inflammatory conditions with autoimmune aetiology with few treatment options and difficult diagnosis.

Their major common feature is the presence of unspecific autoantibodies in serum. Three diseases primarily represent the SADs: systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) and systemic sclerosis (SSc) that show extensive overlap in their presentation. Several other entities and syndromes have extensive clinical overlap with these, where mixed connective tissue disease (MCTD), Sjögren’s syndrome (SSj) and the primary antiphospholipid antibody syndrome (PAPS) are very relevant examples.

While as separate clinical entities each of these diseases is rare, together they make up to close to 1% of the general population. In addition there are individuals who do not fulfil the clinical criteria or who do not share all the features of a given clinical entity and live for years as undifferentiated cases

PRECISESADS

The clinicians and scientists leading this collaboration will study at least 2000 patients living with systemic lupus erythematosus (SLE), systemic sclerosis (SSc), Sjögren’s syndrome (Sjs), rheumatoid arthritis (RA), primary antiphospholipid syndrome (PAPS) and mixed connective tissue disease (MCTD) and 600 healthy controls aiming to identify overlapping clusters of individuals across these diseases that share recognisable molecular features and who consequently may benefit from treatments targeted to address these shared elements of pathology

As a prototype, new promising biological treatments are being developed for SLE, but because of separate disease classification, their use cannot benefit other diseases where shared molecular pathophysiology is suspected, on scientific grounds.

According to Esteban Ballestar, head of Chromatin and Disease group at the Bellvitge Biomedical Research Institute (IDIBELL ) “currently patients are being exposed to novel and approved agents with little chance of benefit due to the heterogeneity of molecular mechanisms resulting in the same disease class” . “Furthermore, pharmaceutical companies confront huge problems when attempting to identify end points to determine the usefulness of drugs in clinical trials and lack biomarkers that help evaluate response to therapy”.

Molecular map

The ultimate goal of PRECISESADS is precisely to deliver a molecular map to guide therapy in systemic autoimmune diseases.

In all, 23 academic and 5 industrial partners from 12 countries spread right across Europe, will work for 5 years with a budget of €22.7 million, €9.9 million of which comes from the European Commission’s Seventh Framework for Research (FP7), and €9.8 million of which comes from in kind contributions by the pharmaceutical companies participating in the project.

Results will be widely shared to deliver a new molecular taxonomy of SAD that can be directly accessed by physicians, patients, regulators and drug developers to help define, refine and discover better treatments for SAD.

the Innovative Medicines Initiative (IMI) is a joint undertaking between the European Union and the pharmaceutical industry association EFPIA, which exists to speed up the development of better and safer medicines.

The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n°115565, resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution

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