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

Project Information

HypoSkin

Grant agreement ID: 816289

DOI

10.3030/816289

Project closed

EC signature date 9 May 2018

Start date 1 June 2018

End date 30 November 2018

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

GENOSKIN SAS
France

Periodic Reporting for period 1 - HypoSkin (Unique breakthrough ex vivo human skin model to predict efficacy and toxicity of subcutaneous drugs)

Reporting period: 2018-06-01 to 2018-11-30

Summary of the context and overall objectives of the project

Drug administration by subcutaneous injection is highly increasing during the past years (average CAGR of 7% between 2014 and 2018). However, low predictability of currents animal models used in preclinical tests leads to 88% of drug attrition during clinical trial causing a loss of more than €1 billion per drug development.
To solve this bad situation, Genoskin developed HypoSkin®, the first and unique, highly predictive and ethical human model to replace animal testing. The model containing living ex vivo human skin biopsies with subcutaneous fat that will be used to reliably test subcutaneous injections of drug.
Our innovative solution disrupts exiting market by replacing animal testing, increasing the human local prediction up to 20% and decreasing more than 5 times tests’ costs. HypoSkin® highly contributes to the European Directive 2010/63/EU legislation “on the protection of animals used for scientific purpose”.
Key players of subcutaneous injection drug market, and HypoSkin® customers, such as Pharmaceuticals Companies and injection Devices Manufacturers are already underlining high HypoSkin’s market potential and breakthrough.
Since Genoskin creation in 2011 our experimented and passionate team already raised €1M of non-dilutive loans, won several international awards: FR Company Challenge, US NETVA, etc. and realized a turnover of €900K in 2018 with its other commercialized human-skin models such as NativeSkin® (the model without subcutaneous fat layer).
The overall objective of the project is to first realize the Phase 1 feasibility study to deepen our knowledge about industrialisation, regulatory requirements and confirm market needs. Then the Phase 2 project will allow the industrialisation and scale-up of HypoSkin® to prepare for the massive international commercialisation in 2021.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

As a part of this SME Instrument Phase 1 feasibility study, the following activities were to (i) characterize HypoSkin® in relation to metabolism; (ii) search for subcontractors for the SME Instrument Phase 2 allowing further pharmacological validation; (iii) analyse new possible rights and Freedom to Operate analysis as well as performed a risk assessment and analysis of bottleneck in the ability to increase profitability of the enterprise through proposed innovative solution; and (iv) conduct a worldwide market study. We have first analyzed metabolic activities of HypoSkin models has been analyzed by using mass spectrometry imaging. The advantage of this approach is to identify and localize metabolites within a tissue sample. Mass spectrometry imaging has demonstrated that HypoSkin® models are metabolically actives.The search of partners to validate the HypoSkin® model was also successful. Several academic and industrial partners were identified and selected to conduct collaborations. Freedom to Operate analysis was also conducted while filing a patent protecting the use of HypoSkin® model for testing subcutaneous administrated drugs. Finally, the worldwide market study was also successful

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Subcutaneous injection using needle and syringe is one of the most common method of drug delivery today. Despite more and more extensive use, there are still no accurate biological models to predict efficacy and toxicity of compound injected in the subcutaneous tissue.
New drugs formulations are generally tested in vivo on animals (mice, rats, dogs, pigs etc.), even though their skin and subcutaneous fat tissue are different from humans. As a result, none of them are recognized as universal and reliable models to predict human subcutaneous bioavailability.
Pharmaceutical industry and medical device manufacturer main pain point is a lack of biological model allowing to truly evaluate and to optimise a new compound’s formulation before clinical trials, which leads to a loss of more than €1 billion per drug development. In addition to the low predictability, animal experiments are expensive and present strong limitation regarding ethical issues.
HypoSkin® is currently the only existing ex vivo test containing human skin with hypodermis allowing reliable testing of subcutaneous injections, with long life time provided in a ready and easy to use format. Expected results until the end of the project are as follows: scale-up, automation and industrialisation, further functional and pharmacological qualification in operational environment (pharmaceutical company) using subcutaneous injection of reference drugs (Insulin and/or monoclonal antibodies for example). All actions necessary for successful market access will be realized such as FDA or EMEA validation of the HypoSkin® model for toxicology/potency testing and the marketing and commercial development: worldwide market study, web site, world-wide communication, congresses, etc.

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