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Unique breakthrough ex vivo human skin model to predict efficacy and toxicity of subcutaneous drugs

Project description

Ex vivo skin models for drug testing

Many drugs are delivered subcutaneously including anti-inflammatory agents and vaccines. It is therefore necessary to assess their efficacy, toxicity, absorption and metabolic impact prior to human administration. The EU-funded HypoSkin project has developed a living skin model for testing the biodistribution and efficacy of various drugs. The model is produced from healthy human tissue and contains all three skin layers (epidermis, dermis and hypodermis). It is supported by a proprietary nourishing matrix that provides an experimental window of over seven days, sufficient for the testing of subcutaneous therapeutics. Moreover, it allows the assessment of immunotoxicity and immunogenicity of vaccines.

Objective

Subcutaneous injection drug market is highly increasing (CAGR of 7%) and is view as a viable alternative route for parenteral drug administration because it enables at-home injection, improves quality of life and reduces health care costs. However, the absence of accurate biological model to predict the effect of drug injection in the subcutaneous tissue limits their development. That issue leads to 88% of drug attrition causing a loss of more than €1B per developed drug and a sharp decrease of patient security during clinical trials.

HypoSkin is the first and unique in vitro standardized and ready-to-use testing kit containing living ex vivo human skin biopsies with subcutaneous fat, allowing pharmaceuticals to highly reliably predict local human’s response to the injection of a drug or a medical device. This disruptive innovation permits Hyposkin’s customers to save time and money (10 times faster and 5 times cheaper than animal experiment, confirmed in the on-going payed pilot test) as well as secure the development of their products before clinical trials. HypoSkin will become worldwide reference method to replace inadequate animal testing currently used today.

HypoSkin model is developed by Genoskin an innovative French company, founded in 2011 as a spin-off of the French National Center for Scientific Research and the Paul Sabatier University in Toulouse. Genoskin provides other human-skin alternative models to pharmaceuticals companies all over the world leading to sales of €700K in 2017.

The SME Instrument project will allow the company to improve, qualify and industrialise HypoSkin. To accomplish this goal Genoskin will complete a feasibility study to further analyse risks and cost of scale-up, the European regulatory framework and will deepen and sharpen the global subcutaneous injection market.
Genoskin plans to lead the European and global alternative method market with an estimated turnover of € 34 M by 2024, and 110 new European and worldwide jobs.

Fields of science (EuroSciVoc)

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Programme(s)

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Topic(s)

Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.

Funding Scheme

Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.

SME-1 - SME instrument phase 1

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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) H2020-EIC-SMEInst-2018-2020

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Coordinator

GENOSKIN SAS
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.

€ 50 000,00
Address
CENTRE PIERRE POTIER, 1 PLACE PIERRE POTIER
31100 TOULOUSE
France

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Occitanie Midi-Pyrénées Haute-Garonne
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
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.

€ 71 429,00
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