An integrated upper GI model of digestion and absorption - the commercial 'Holy Grail'

Lead Research Organisation: Newcastle University
Department Name: Inst for Cell and Molecular Biosciences

Abstract

Modelling the processes of digestion, nutrient uptake and drug absorption in the laboratory reduces the need to carry out expensive and controversial studies in animals and humans. We aim to develop a fully integrated lab model of digestion and absorption to screen and develop new drugs and health interventions. The commercial need in the pharmaceutical industry for this model has been identified during a BBSRC Enterprise Fellowship and validated through independent market research funded by a BBSRC Pathfinder award, and we have applied for a patent of this technology. This integrated model has been described as the 'Holy Grail' and would allow food and pharmaceutical companies to carry out affordable screening and development studies to inform product development and drug discovery. This would significantly reduce the high costs of drug development. Furthermore an effective, validated model of digestion would reduce the need for a great number of animal studies.

Publications

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Wilcox MD (2021) The effect of seaweed enriched bread on carbohydrate digestion and the release of glucose from food. in Journal of functional foods

 
Description We have developed the integrated small-intestinal model as specified in the project plan.

The model has been used in a number of commercial projects, and is currently being validated with a library of compounds that have human absorption data.

A gastric damage model has also been developed to test new and reformulated Non steroidal anti inflammatory drugs (NSAID). This model has also been used in several commercial projects, demonstrating the protective properties of mucus. We have developed a cell based model protected by the mucus layer to investigate, closer to the in vivo situation of drug absorption.
This model has been described by Ann Taylor-Hutchinson of Oxford PharmaScience
"Using the integrated gastric model to assess gastric damage has been very valuable to our research and development pipeline. Our interest has been in assessing the effect of our formulations on the epithelia in relevant Gl secretions with a mucus barrier present. This has been very useful to us."

A spin out company Aelius Biotech has been developed to aid in the commercialisation of these models and is trading.
The company website is; - www.aeliusbiotech.co.uk/
Exploitation Route The model is being used by a number of pharmaceutical companies, and is being made available as a contract research service.

This service forms the basis of a contract research spin-out from Newcastle University. The spin out company is trading and registered at companies house. Further customers are being sought.
The model is being well received by industry with the following testimonials

Jon Farrimond. Scientific and Regulatory Affairs Suntory Beverage and Food (Europe)
"We have worked with Aelius Biotech on the development of two products that have gone to human trials to support EFSA health claims and have seen the value that reliable in vitro models can provide. The model has helped us make numerous key decision and investments. I am sure these models will be used by industry to accelerate and improve product development."

Dr Craig Rose. Managing Director Seaweed & Co.
"Working with Aelius and their human gut model proved to be an extremely cost effective way to run trials on our products. This data guided future research for human trials, as well as giving highly relevant and credible results for scientific publications and commercial successes."
Sectors Agriculture, Food and Drink,Chemicals,Environment,Healthcare,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology
URL http://www.aeliusbiotech.co.uk
 
Description This model is being used by pharmaceutical and food companies on a contract research basis. A spin-out company from Newcastle University has been developed. Aelius Biotech has been registered at companies house this company will uses the models developed in this grant. In particular the small intestinal absorptive model. Building on from this project, the spin out company, Aelius Biotech, has grown and is employing staff. The technology and the models that were produced via this project have been further developed and new intellectual property around the mucus barrier is being filed.
First Year Of Impact 2016
Sector Agriculture, Food and Drink,Chemicals,Environment,Healthcare,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology
 
Description An integrated upper GI model of digestion and absorption - the commercial 'Holy Grail'
Amount £152,719 (GBP)
Funding ID BB/N012666/1 
Organisation Biotechnology and Biological Sciences Research Council (BBSRC) 
Sector Public
Country United Kingdom
Start 04/2016 
End 09/2017
 
Title Integrated small intestinal model 
Description The pathfinder award allowed us to understand the market need for an absorptive gastrointestinal model. With this we applied for follow on funding, and developed the first cell culture model capable of integrating a mucus barrier and digestive fluids. 
Type Of Material Model of mechanisms or symptoms - in vitro 
Year Produced 2017 
Provided To Others? Yes  
Impact The developed model has been used in commercial projects to assist drug development with Boehringer Ingelheim, Oxford Pharmascience and Suntory 
 
Title Model Gut System 
Description The system mimics the chemical and enzymatic digestion taking place in the upper digestive tract of a human, from the mouth to the end of the small intestine. 
Type Of Material Model of mechanisms or symptoms - in vitro 
Year Produced 2013 
Provided To Others? Yes  
Impact This tool was used to screen numerous bioactive compounds and correctly predict the outcomes of the clinical trial based on them. 
URL http://www.ncl.ac.uk/business/commercialisation/transfer/biomedical-sciences/mgs.htm
 
Description Capsugel 
Organisation Capsugel
Country United States 
Sector Private 
PI Contribution Commercial work Drug delivery
Collaborator Contribution Commercial contract
Impact Commercial work/drug delivery
Start Year 2017
 
Description Oxford Pharmascience 
Organisation Oxford Pharmascience
Country United Kingdom 
Sector Private 
PI Contribution Commercial research Drug delivery
Collaborator Contribution Commercial research
Impact IP Generation
Start Year 2017
 
Description Suntory 
Organisation Suntory Holdings Limited
Country Japan 
Sector Private 
PI Contribution Several commercial projects totalling £50,000+Functional food research
Collaborator Contribution Paid for services
Impact IP Generation
Start Year 2017
 
Company Name AELIUS BIOTECH LIMITED 
Description Aelius Biotech specialise in lab models of the aerodigestive tract. Our predictive systems can help you understand your formulation during vital pre-clinical stages to help you improve and de-risk product development and get successful products to market. 
Year Established 2018 
Impact Data from the MGS showed that alginate is released in the small intestinal phase- the major site of lipase activity and significantly reduced fat digestion. The in vitro data built a solid evidence base for subsequent in vivo human studies. After a successful acceptability study a pilot human proof of principle study then went on to demonstrate that alginate bread can reduce the level of circulating triglycerides in plasma after a meal as well as significantly increase the level of fat in ileal effluent. Jon Farrimond. Scientific and Regulatory Affairs Suntory Beverage and Food (Europe) - "We have worked with Aelius Biotech on the development of two products that have gone to human trials to support EFSA health claims and have seen the value that reliable in vitro models can provide. The model has helped us make numerous key decision and investments. I am sure these models will be used by industry to accelerate and improve product development."
Website https://aeliusbiotech.co.uk/