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Folate-Target Nanodevices To Activated Macrophages For Rheumatoid Arthritis

Objective

FOLSMART will bring to phase I clinical trials novel folate-based nanodevices (FBN) for the treatment of rheumatoid arthritis (RA). These nanodevices for folic acid (FA)-mediated targeting of activated macrophages showed improved clinical scores in a mouse model of RA when compared to methotrexate (MTX), a first-line drug therapy for the treatment of RA. In this way, FBN will be benchmarked against this drug. MTX has significant associated toxicity and second line biological therapies poses a great economic burden to hospital/public health systems. In parallel, nanodevices encapsulating Sulfasalazine (SSZ), will be tested. SSZ is a second line indication for the treatment of RA, unresponsive to MTX or MTX–intolerant patients. Furthermore, FOLSMART propose the optimization of mechanisms for the release of the drugs, through pH and temperature sensitive nanodevices. An exploitation and business plans will be elaborated. In parallel, initial economic evaluation of all proposed treatments will be performed to validate these claims.

Specific technological objectives of FOLSMART will be:

Good Manufacturing Practice (GMP) production of the FBN based therapies which have been positively bench-marked in the previous FP7 European project NANOFOL in comparison with the use of MTX in a RA mouse model:
-Liposomal MTX and SSZ with FA-“neck domain” peptide as targeting agent
-Nanoparticles from HSA-FA/MTX conjugates and SSZ
-Optimization of mechanisms of drug release and application to other fields

Pre-clinical development on RA models
-Toxicology and pharmacokinetics, to determine tolerability and efficacy benefit in two animal models rat and dog, under Good Laboratory Practice (GLP) standards
-Genotoxicity and Carcinogenicity

Phase I clinical trials of the best therapies bench marketed against MTX
-Nanodevices with MTX and SSZ will offer improved tolerance and greater efficacy meaning that patients who do not do well on MTX will have cost-effective alternatives
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Coordinator

ASSOCIACAO UNIVERSIDADE EMPRESA PARA DESENVOLVIMENTO TECMINHO

Address

Campus De Azurem Universidade Do Minho
4800 058 Guimaraes

Portugal

Activity type

Other

EU Contribution

€ 1 142 037,70

Participants (10)

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SYNOVO GMBH

Germany

EU Contribution

€ 300 000

UNIVERSITAET FUER BODENKULTUR WIEN

Austria

EU Contribution

€ 399 556,25

BLUECLINICAL - INVESTIGACAO E DESENVOLVIMENTO EM SAUDE LDA

Portugal

EU Contribution

€ 629 845

MEDIZINISCHE UNIVERSITAET WIEN

Austria

EU Contribution

€ 404 510

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE

France

EU Contribution

€ 488 400

INSTITUTO DE BIOLOGIA MOLECULAR E CELULAR-IBMC

Portugal

EU Contribution

€ 436 823,75

GABO:MI GESELLSCHAFT FUR ABLAUFORGANISATION:MILLIARIUM MBH & CO KG

Germany

EU Contribution

€ 8 875

APTUIT (VERONA) SRL

Italy

EU Contribution

€ 544 440

BLUEPHARMA - INDUSTRIA FARMACEUTICASA

Portugal

EU Contribution

€ 327 671,05

SOLFARCOS - SOLUÇÕES FARMACÊUTICAS E COSMÉTICAS LDA

Portugal

EU Contribution

€ 311 675

Project information

Grant agreement ID: 683356

Status

Ongoing project

  • Start date

    1 January 2016

  • End date

    30 June 2020

Funded under:

H2020-EU.2.1.2.2.

H2020-EU.2.1.2.5.

H2020-EU.2.1.2.3.

  • Overall budget:

    € 4 993 833,75

  • EU contribution

    € 4 993 833,75

Coordinated by:

ASSOCIACAO UNIVERSIDADE EMPRESA PARA DESENVOLVIMENTO TECMINHO

Portugal