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Preclinical development of a nanomedicine candidate for Fabry rare disease treatment to enter clinical phase

Project description

Advanced nanoencapsulation for Fabry disease therapy

Fabry disease is a rare genetic disorder caused by the deficiency of the enzyme alpha-galactosidase A, which is implicated in the breakdown of fats. This results in the excessive deposition of lipids in tissues including the brain, pain in the hands and feet as well as heart and kidney dysfunction. Treatment usually entails enzyme replacement for life. The EIC-funded Nano4Rare project aims to test an innovative formulation for the treatment of Fabry disease based on KET, a patented nanoencapsulation technology that promises cost-effective therapies for rare diseases. Nano4Rare will complete the preclinical phase, ensuring safety and efficacy data, before this new formulation moves toward clinical trials.

Objective

"Despite the development of new orphan medicines in recent years, there are still limited treatment options available for rare diseases. Nano4Rare team has developed a patent protected nanoencapsulation KET for the development of cost-effective therapies for rare diseases, based on biomolecules. Nano4Rare team has successfully used this technology for the development of a new patent protected medicinal product candidate, named nanoGLA, for the treatment of Fabry disease, which is one of the most devasting LSD rare diseases. NanoGLA has been designated, on January 2021, as Orphan Drug by the European Medicine Agency (EMA) and the European Comission. With the EU H2020 Smart4Fabry, nanoGLA was brought to an advanced stage of preclinical development (first GLP-toxicology in rats included). Under Phoenix EU Project (#953110)(2021-2025), nano-GLA production will be scaled-up and brought to GMP conditions. As a first objective, Nano4Rare project will use nanoGLA engineered batches produced in the frame of Phoenix project to complete the preclinical phase and generate sufficient quality data on safety, efficacy, and quality in order to get approval by regulators to proceed with clinical phase. As a second objective, a new spin-off company will be created for the advancement of the nanoGLA towards the market and the commercialisation of the patent protected nanoencapsulation platform to generate new product candidates for rare disease treatments."

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Topic(s)

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HORIZON-EIC - HORIZON EIC Grants

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Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

(opens in new window) HORIZON-EIC-2023-TRANSITION-01

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Coordinator

AGENCIA ESTATAL CONSEJO SUPERIOR DE INVESTIGACIONES CIENTIFICAS
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 1 252 138,94
Address
CALLE SERRANO 117
28006 MADRID
Spain

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Region
Comunidad de Madrid Comunidad de Madrid Madrid
Activity type
Research Organisations
Links
Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 2 498 563,75

Participants (1)

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