Press Release: NECESSITY Project Officially Started

Primary Sjögren’s syndrome (pSS) is a systemic autoimmune disease (AID) characterised by lymphocyte infiltration of salivary and lacrimal glands that leads to progressive xerostomia and xerophtalmia. Fatigue and limb pain are also common symptoms. Systemic and extra-glandular manifestation may develop in one-third of patients, and includes arthritis, fever, vasculitis, peripheral neuropathy, synovitis, kidney involvement and interstitial lung disease. Moreover, pSS patients have a 10 to 20-fold higher risk of developing B-cell lymphomas, conferring shorter lifetime expectancy to these patients.

In the past two decades, 11 new targeted-immunomodulatory treatments have been marketed for rheumatoid arthritis; however, only one drug has been licensed for other systemic autoimmune diseases (AIDs), belimumab, in systemic lupus erythematous (SLE). Several factors may have hampered the development of successful drugs. AIDs are multi-organ diseases and considerably heterogeneous among individuals, both in terms of clinical manifestations and biological disturbances. As a consequence, it is challenging to set up accurate clinical end-points sensitive to change and that are feasible in clinical trials.

Objectives of NECESSITY

The NECESSITY project aims to overcome these challenges with three objectives to enhance the development of new medicines for pSS:

• To develop and assess sensitive clinical endpoints to evaluate response to drug treatments in patients with pSS;
• To identify and evaluate discriminative biomarkers for stratification of pSS patients;
• To design and perform a multi-arm multi-stage clinical trial to validate the newly defined pSS endpoints and the identified biomarkers.

Kick-Off Meeting in Paris

The kick-off meeting for the NECESSITY project took place in Paris from 16-17 January 2019. The project consortium was represented by 21 academic partners and four EFPIA member companies representing nine European countries: United Kingdom, France, Italy, Switzerland, Netherlands, Spain, Sweden, Greece and Norway.

Impact

The NECESSITY project, by bringing together relevant stakeholders including academia, pharmaceutical industry, health authorities, payors and patient groups, is expected to generate impactful novel tools and capabilities for the confirmation of new endpoints and design of new pSS clinical trials to ultimately facilitate new drug development for patients with pSS.

In the field of autoimmunity, given the frequency of pSS and the absence of any treatment available, finding an efficient
treatment for patients is a key unmet medical need which will be more easily achieved by combining Horizon 2020
and private sector funds in a public-private partnership

Laboratory assays and bioinformatics methodology implemented in this project will be transferable to other autoimmune
diseases. The conceptual approach that we will take in the translational part of the project aims at identifying
biomarkers able to address both autoimmune activation and organ damage will be also relevant to other autoimmune
conditions characterised by organ involvement. Similarly, our new original stratification and umbrella trial will be
applicable to other complex auto-immune diseases such as systemic lupus erythematosus and systemic sclerosis.

For more information, download the full press release / fact sheet

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant
agreement No 806975. This Joint Undertaking receives support from the European Union’s Horizon 2020
research and innovation programme and EFPIA.