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September, 2016

EC granted € 5M to a consortium in which Blueclinical is responsible for the regulatory plan and early clinical trials

Blueclinical is part of a H2020 Consortium which is working on an innovative approach to treat Rheumatoid Arthritis. It should reach phase I clinical trials in 2018.

The FOLSMART project, the direct successor of the EU funded research project NANOFOL, aims for a treatment improvement in Rheumatoid Arthritis and focuses on folate-targeted nanodevices for the activation of macrophages. The main objectives of FOLSMART are the translation of the laboratory-based medication into Phase I clinical trials

FOLSMART consortium is constituted by 7 European partners: Blueclinical (Portugal), TecMinho (Portugal), IBMC (Portugal), INSERM (France), Universität für Bodenkultur (Austria), Medizinische Universität Wien (Austria) and Synovo GmbH (Germany).

The project which started this year will run until 2019 and is funded by the European Commission. FOLSMART was awarded almost €5M to bring the novel folate-based nanodevices as a treatment option for Rheumatoid Arthritis to Phase I clinical trials. Blueclinical will be responsible by the conduction of phase I clinical trials and all the related regulatory documents namely: development plans, study plans, study reports, regulatory briefing packages and investigator’s brochure. Phase I clinical trials are foreseen to start in 2018. Whether or not the Phase I study needs to be conducted in patients or healthy subjects is dependent on results obtained in the non-clinical studies, which will be performed in animals. Healthy trial subjects may be recruited from Blueclinical Phase I’s pool of healthy volunteers; RA patients may be recruited from Blueclinical CRP network.

The project coordinator, Prof. Artur Cavaco-Paulo believes that “Not only will the patients benefit from the improved clinical outcomes but also the Health systems’ efficiency will be improved by avoiding an early start of biologic therapy”.

FOLSMART also aims to establish the spin-off company Folmatech, which will produce and distribute the new therapeutic compound.