About STICHTING GROUP FOR RESEARCH AND ASSESSMENT OF PSORIASIS AND PSORIATIC ARTHRITIS EU (GRAPPA EU)

The Innovative Medicines Initiative (IMI) is a jointly funded partnership between the European Union, represented by the European Commission, and the European Federation of Pharmaceutical Industries and Associations (EFPIA). In consultation with EFPIA, IMI periodically issues a call for proposals for research projects in specific therapeutic areas following the principle that research related to the future of medicine should be undertaken in areas where societal, public health and biomedical industry competitiveness goals are aligned and require the pooling of resources and greater collaboration between the public and private sectors. IMI also seeks the involvement of small and medium-sized enterprises. The IMI objectives are usually implemented through projects where public and private partners collaborate in a consortium, joining their expertise, knowledge, and resources.

The IMI has recently issued a call for research proposals relating to psoriatic arthritis. Specifically, the call seeks proposals for a collaborative research project related to the early diagnosis, prediction of radiographic outcomes and development of rational, personalised treatment strategies to improve long-term outcomes in psoriatic arthritis.

Psoriatic arthritis (PsA) is a chronic immune-mediated disease involving axial and peripheral joints, nails, skin, and enthesis. Cutaneous manifestations often precede articular symptoms and it has been estimated that about 20-30% of psoriatic patients develops arthritis or enthesitis over the time. Although still a matter of debate, the pathogenesis of PsA is multifactorial and includes genetic and environmental triggers, like dysbiosis, infections or a mechanic stress, which could induce and maintain the aberrant activation of the innate and adaptive immune system.

GRAPPA EU has identified several areas of unmet need focused on the early diagnosis of PsA that are within the scope of the IMI call for proposals and GRAPPA EU is forming a consortium  to apply for the IMI grant in response to this call. There are a large number of patients suffering from PsA that are diagnosed after several years of signs and symptoms (late diagnosis) and fail to respond to current standard of care treatments or quickly relapse on, or following treatment. Currently, it is felt that the earlier PsA can be diagnosed, the better the treatment could influence the disease. It also seems that the physiopathology of PsA evolves with the “age” of the disease which may give opportunities to discover new targets in early PsA patients. GRAPPA EU consortium research proposal will focus in areas relating to early diagnosis of PsA.

The grant from the IMI to the successful applicant-consortium will consist of a total of approximately €12 million in cash and an equivalent amount in in-kind contributions from pharmaceutical organizations such as contributions of patient samples, clinical data, and expertise. The GRAPPA EU proposal, in keeping with IMI guidelines, will involve a consortium including small and medium sized research organizations and academic institutions, patient adovcates and others, each of whom will have a specific role in the research project. The role of GRAPPA EU will be defined by its consortium, but is likely to include contributions of expertise related to psoriatic arthritis from GRAPPA members and from patients who are members of the GRAPPA patient advocacy group worldwide, and related management activities by GRAPPA EU.

The IMI grant process involves an initial response to the proposal due early in 2020 and a detailed formal application to be submitted in April 2020. GRAPPA EU has applied for the IMI grant. From all of the consortium-applicants, the IMI will select one proposal and consortium applicant for further discussion and refinement of the research project and the development of a detailed project plan and detailed budget. The budget will define how the cash and in-kind components of the grant will be applied, which consortium members will receive grants funds and in-kind contributions and the specific services for which these are provided. If agreement is reached with the IMI and all consortium members on all aspects of the research project and budget, the research project will commence in the second quarter of 2021 and is expected to last at least 60 months. As part of the IMI requirements, regular reporting on the progress of the research project and the use of the cash and in-kind contributions will be required. At present, it is too early to say with any specificity the amount of funds which may flow to GRAPPA EU if the application by its consortium is successful as that will depend upon the specific tasks which will fall to GRAPPA EU under the research project plan and budget but may include reimbursement for travel and other expenses of of providing expertise, and reimbursement for administrative services.

In addition to applying for the grant from IMI, GRAPPA EU will explore other sources of research funding for research projects related to psoriasis and psoriatic arthritis including Horizon 2020, Foreum and the Wellcome Trust.  Horizon 2020 is an EU sponsored research and innovation program that, like the IMI periodically issues calls for research propsals.  While Horizon 2020 may expire in 2020, it is expected to be renewed for an additional period. The Wellcome Trust is a well-known foundation based in the United Kingdom that is focused on funding health-related initiatives, including biomedical research and development.  Foreum is a scientific research funding organization affiliated with European League Against Rheumatism (EULAR), the European Union professional organization focused on rheumatology.  Psoriasis and psoriatic arthritis fall under the umbrella of rheumatology and GRAPPA EU will look to submit proposals in response to any Foreum call related to those therapeutic areas.

Pending receipt of IMI or other funding and to the extent not within the scope of grant funding agreements, the ongoing costs of operations and legal compliance for GRAPPA EU will be paid by funds donated by its US affiliated organization, GRAPPA.