Periodic Reporting for period 4 - PeptiEUForce (PeptiEUForce: a game-changing ingredient for the pre-diabetic population)
Período documentado: 2020-03-01 hasta 2021-08-31
Diabetes has been recognised as an epidemic globally and within the EU. Environmental and behavioural changes over the last century, such as a sedentary lifestyle, intake of calorie dense/sugary foods and obesity are all significant contributors in creating a dramatic increase in the incidence of diabetes globally. There are about 60 million people, 11% of the total population, with diabetes in the European Region (WHO 2010). This number will swell to 15% of the EU population by 2030. Europe spent €89 billion on directly treating and managing diabetes and its related complications in 2011 (International Diabetes Federation 2011). This cost, however, is severely understated as the true cost of diabetes also includes indirect costs, such as productivity losses due to lost working time through absenteeism, sickness, early retirement and premature death (Kanavos 2012). The WHO projects that diabetes will be the 7th leading cause of death in 2030 and it is already the fourth in most developed countries in the world.
Without intervention, prediabetes is likely to become type 2 diabetes in 10 years or less (Mayo Clinic 2014). The increasing number of new cases of prediabetes presents a global concern as it carries large-scale implications towards the future burden on healthcare. Between 2003 and 2011, the prevalence of prediabetes in England alone more than tripled, with 35.3% of the adult population, or 1 in every 3 people, having prediabetes (Arch G Mainous III 2014). The International Journal of health science succinctly states a well-accepted fact: “intervention prior to the onset of type 2 diabetes may be the only way of preventing the complications of diabetes”. In addition, diabetes, once it occurs, is irreversible, thus prevention holds the last beacon for epidemic control in the future.
Whilst significant lifestyle changes can be impactful, sustained compliance is very limited and therefore results are poor (EC 2010). As a result, the European Commission has highlighted functional foods as valuable solutions for treatment and prevention of diabetes (EC 2010). A functional food, “beneficially affects one or more target functions in the body beyond adequate nutritional effects in a way that is relevant to either an improved state of health and well-being and/or reduction of risk of disease (EC 2010).
Specific objectives and expected outcome of our innovative business project:
The overall objective of this SME Instrument (SMEI) project is to deliver a scientifically/clinically validated food ingredient, PeptiForce, that successfully impacts the rapidly growing epidemic of diabetes.
Without intervention, prediabetes is likely to become type 2 diabetes in 10 years or less (Mayo Clinic 2014). The increasing number of new cases of prediabetes presents a global concern as it carries large-scale implications towards the future burden on healthcare. Between 2003 and 2011, the prevalence of prediabetes in England alone more than tripled, with 35.3% of the adult population, or 1 in every 3 people, having prediabetes (Arch G Mainous III 2014). The International Journal of health science succinctly states a well-accepted fact: “intervention prior to the onset of type 2 diabetes may be the only way of preventing the complications of diabetes”. In addition, diabetes, once it occurs, is irreversible, thus prevention holds the last beacon for epidemic control in the future.
Whilst significant lifestyle changes can be impactful, sustained compliance is very limited and therefore results are poor (EC 2010). As a result, the European Commission has highlighted functional foods as valuable solutions for treatment and prevention of diabetes (EC 2010). A functional food, “beneficially affects one or more target functions in the body beyond adequate nutritional effects in a way that is relevant to either an improved state of health and well-being and/or reduction of risk of disease (EC 2010).
Specific objectives and expected outcome of our innovative business project:
The overall objective of this SME Instrument (SMEI) project is to deliver a scientifically/clinically validated food ingredient, PeptiForce, that successfully impacts the rapidly growing epidemic of diabetes.
To date, many milestones have been achieved in Work Package One and Two as demonstrated in both Part A of the report and Part B uploaded to the portal.
Work Package One involves the scale-up of manufacturing. The objective of this work package is to manufacture a finalised ingredient for clinical trial usage and demonstrate our ability to scale our ingredient for high volume commercial quantities. This objective has been achieved for our first of three clinical trials.
Work Package Two involves the demonstration of clinical efficacy. The objective of this work package is to gain scientific validation required in human trials to demonstrate the benefit in using our ingredient in the prevention of diabetes. A series of three clinical trials will be performed to demonstrate efficacy in humans for the “maintenance of blood glucose levels”. The first of the three trials, the Proof of Concept trial is ongoing.
Learning dissemination is a key focus point for Nuritas and ensuring that all learnings are shared and implemented across the company. These learnings have ensured that the issues such as the incidents with the initial CRO were managed in a proactive manager and ensure the risk was a minimum and the objective of the project would be achieved with the highest standards. These are implemented by processes that have been implemented and areas that will be further expanded with the assistance of the organisational coach.
Work Package One involves the scale-up of manufacturing. The objective of this work package is to manufacture a finalised ingredient for clinical trial usage and demonstrate our ability to scale our ingredient for high volume commercial quantities. This objective has been achieved for our first of three clinical trials.
Work Package Two involves the demonstration of clinical efficacy. The objective of this work package is to gain scientific validation required in human trials to demonstrate the benefit in using our ingredient in the prevention of diabetes. A series of three clinical trials will be performed to demonstrate efficacy in humans for the “maintenance of blood glucose levels”. The first of the three trials, the Proof of Concept trial is ongoing.
Learning dissemination is a key focus point for Nuritas and ensuring that all learnings are shared and implemented across the company. These learnings have ensured that the issues such as the incidents with the initial CRO were managed in a proactive manager and ensure the risk was a minimum and the objective of the project would be achieved with the highest standards. These are implemented by processes that have been implemented and areas that will be further expanded with the assistance of the organisational coach.
How our project addresses EU-wide challenges:
The International Diabetes Federation (IDF) clearly states in its 2015 Diabetes Atlas that “diabetes is one of the largest global health emergencies of the 21st century” (IDF, 2015). With an estimated 415 million people with type 2 diabetes globally and another 335 million with impaired glucose tolerance (prediabetic stage) on a planet of 7 billion people, the term “health emergency” seems indeed fitting. Europe is equally realistic about the epic proportions of the problem, noting that ‘70% to 80% of healthcare costs are spent on chronic diseases’ and that ‘chronic diseases represent the major share of the burden of disease in Europe and are responsible for 86% of all deaths in the region.’ (EC 2013). As recognised by the EC: ‘Addressing the burden of chronic disease is a central priority for the European Union and its Member States. We cannot ensure sustainable health systems without addressing the underlying economics of behaviour and chronic diseases.’ (EC, 2013). A key element in the solution mix is to fix the current health spending mismatch with, incredibly enough, about 97% of health budgets presently spent on treatment whereas only 3% are invested in prevention (EC, 2013). The European Commission is adamant: ‘Within Member States, there is an urgent need to change the imbalance between prevention and care in health budgets. Investing in prevention will help to avoid paying for treatment in the future’ (EC, 2013).
And this is where PeptiForce comes into play. Here is an opportunity to fund a natural ingredient, having withstood the rigours of scientific validation that delivers real hope to slow the onslaught of diabetes. We are aware that the impact of public funding programmes is primarily measured in terms of growth and job creation but we are convinced that the greatest impact which our project PeptiEUForce can generate is in social and economic terms: longer and better lives for millions of prediabetics (and diabetics) across the globe and massive savings for our overstretched health systems by sparing millions the irreversible fall into type 2 diabetes.
We have already predicted, discovered, extracted and proven the benefit of PeptiForce in independent laboratories. The further scientific validation through the EFSA 13.5 approved claim as sought with this project would place us in a unique position. There are no non-pharmaceutical ingredients that have anything approaching a similar level of claim in this area. Similarly, much higher priced, side effect issuing diabetic drugs are only licensed for use with existing diabetics and not prediabetics.
Therefore, we operate in a market of great and growing need, and can deliver cost-effective natural ingredients with scientifically validated benefits that currently have NO competition.
The eventual EFSA health claim is of great strategic importance for the gradual commercialisation of our entire peptide portfolio. This will both accelerate and amplify our growth as a total organisation. The clinical and commercial success resulting from this EU-funded project will also further reinforce investor confidence in our ability to scale, and place Nuritas in a very positive position for substantial follow-up funding, which we understand to be the spirit of the SME Instrument programme.
The International Diabetes Federation (IDF) clearly states in its 2015 Diabetes Atlas that “diabetes is one of the largest global health emergencies of the 21st century” (IDF, 2015). With an estimated 415 million people with type 2 diabetes globally and another 335 million with impaired glucose tolerance (prediabetic stage) on a planet of 7 billion people, the term “health emergency” seems indeed fitting. Europe is equally realistic about the epic proportions of the problem, noting that ‘70% to 80% of healthcare costs are spent on chronic diseases’ and that ‘chronic diseases represent the major share of the burden of disease in Europe and are responsible for 86% of all deaths in the region.’ (EC 2013). As recognised by the EC: ‘Addressing the burden of chronic disease is a central priority for the European Union and its Member States. We cannot ensure sustainable health systems without addressing the underlying economics of behaviour and chronic diseases.’ (EC, 2013). A key element in the solution mix is to fix the current health spending mismatch with, incredibly enough, about 97% of health budgets presently spent on treatment whereas only 3% are invested in prevention (EC, 2013). The European Commission is adamant: ‘Within Member States, there is an urgent need to change the imbalance between prevention and care in health budgets. Investing in prevention will help to avoid paying for treatment in the future’ (EC, 2013).
And this is where PeptiForce comes into play. Here is an opportunity to fund a natural ingredient, having withstood the rigours of scientific validation that delivers real hope to slow the onslaught of diabetes. We are aware that the impact of public funding programmes is primarily measured in terms of growth and job creation but we are convinced that the greatest impact which our project PeptiEUForce can generate is in social and economic terms: longer and better lives for millions of prediabetics (and diabetics) across the globe and massive savings for our overstretched health systems by sparing millions the irreversible fall into type 2 diabetes.
We have already predicted, discovered, extracted and proven the benefit of PeptiForce in independent laboratories. The further scientific validation through the EFSA 13.5 approved claim as sought with this project would place us in a unique position. There are no non-pharmaceutical ingredients that have anything approaching a similar level of claim in this area. Similarly, much higher priced, side effect issuing diabetic drugs are only licensed for use with existing diabetics and not prediabetics.
Therefore, we operate in a market of great and growing need, and can deliver cost-effective natural ingredients with scientifically validated benefits that currently have NO competition.
The eventual EFSA health claim is of great strategic importance for the gradual commercialisation of our entire peptide portfolio. This will both accelerate and amplify our growth as a total organisation. The clinical and commercial success resulting from this EU-funded project will also further reinforce investor confidence in our ability to scale, and place Nuritas in a very positive position for substantial follow-up funding, which we understand to be the spirit of the SME Instrument programme.