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Smart-4-Fabry

Financiado

Smart multifunctional GLA nanoformulation for Fabry disease

Lysosomal storage disorders (LSD) diseases are a group of rare diseases that currently lack a definitive cure. LSD incidence is about 1:5,000 - 1:10,000, representing a serious global health problem. In the case of Fabry LSD Disea... ver más

31/12/2020

CENTRO DE INVESTIG...

6M€

Presupuesto del proyecto: 6M€

Líder del proyecto

CENTRO DE INVESTIGACION BIOMEDICA EN RED CIBE... Otra investigación y desarrollo experimental en ciencias naturales y técnicas asociacion

TRL 4-5 | 50K€

Ver 14 Participantes

Financiación concedida El organismo H2020 notifico la concesión del proyecto el día 2020-12-31

NMBP-10-2016: Nanoformulation of biologicals

I+D

Cerrada hace 9 años

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14 Participantes

CENTRO DE INVESTIGACION BIOM...

1.82M€ | Lider

BIOSYSTEMS

275.52K€ | Participante

TECHNION ISRAEL INSTITUTE O...

393.71K€ | Participante

FUNDACIO HOSPITAL UNIVERSITA...

266.30K€ | Participante

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Duración del proyecto: 49 meses Fecha Inicio: 2016-11-22
Fecha Fin: 2020-12-31

Líder del proyecto

CENTRO DE INVESTIGACION BIOMEDICA EN RED CIBE... Otra investigación y desarrollo experimental en ciencias naturales y técnicas asociacion

TRL 4-5 | 50K€

Presupuesto del proyecto 6M€

Descripción del proyecto Lysosomal storage disorders (LSD) diseases are a group of rare diseases that currently lack a definitive cure. LSD incidence is about 1:5,000 - 1:10,000, representing a serious global health problem. In the case of Fabry LSD Disease (FD), the deficiency in α-Galactosidase A (GLA) enzyme activity results in the cellular accumulation of neutral glycosphingolipids, leading to widespread vasculopathy with particular detriment to the kidneys, heart and nervous system. The current treatment for FD is the Enzyme Replacement Therapy (ERT), in which free GLA recombinant protein is administered intravenously to patients. ERT exhibits several drawbacks mainly related to the instability, high immunogenicity and low efficacy of the exogenously administered GLA to cross biological barriers, such as cell membranes and BBB.The aim of Samrt-4-Fabry project is to achieve excellent quality control over the assembly of the different molecular components of a new liposomal nanoformulation of GLA, nano-GLA, for the treatment of Fabry disease. Nanoformulated GLA has already shown to have better PK/PD profile than free GLA and higher efficacy in vivo. Smart-4-Fabry project will advance nano-GLA from an experimental PoC (TRL3) to preclinical regulatory phase (TRL5-6). A one-step method based on the use of green cCO2, will be used for the manufacturing of this novel nanoformulation under GMPs. The final GLA nanoformulation will have tailored transport of GLA through cell membranes and BBB. Fulfillment of Smart-4-Fabry will impact on a major health problem, the existence of new therapies for rare diseases, which constitutes a priority societal challenge as shown in the H2020 Work Programmes. Another important impact is related to its contribution to support the European Strategy for KETs, which aims to reverse the decline in manufacturing as this will stimulate growth and jobs. Smart-4-Fabry is strongly focusing on three KETs: nanotechnology, industrial biotechnology and advanced materials.

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