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H2020

SULIPRO Report Summary

Project ID: 763100

Periodic Reporting for period 1 - SULIPRO (A scientifically proven, safe, naturally derived drug for the effective treatment of liver damage - an innovative solution for a significant unmet medical need)

Reporting period: 2017-02-01 to 2017-05-31

Summary of the context and overall objectives of the project

There is a significantly unmet need for NAFLD treatments. Despite the rising incidence, a definitive treatment for NAFLD, specifically NASH, has not yet been established. Dietary changes combined with regular aerobic exercise, have been shown to have some therapeutic impact, but this approach has been met with low compliance rates. As the rates of obesity and diabetes rise, so do the levels of this disease, now affecting up to 30 % of the population in western countries resulting in increased liver cirrhosis, liver cancer and death.

Natural Shield have developed a specialised oral therapeutic, called SULIPRO, which is a combination of soy derived compounds, that has been proposed as a novel, scientifically-proven safe treatment for patients in the early stages of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). SULIPRO is a novel, patent-protected therapeutic extract, composed of sphingolipids (plant sterols and soy derived extracts), as well as an adjuvant for improved drug delivery. The active ingredients include CardioAid™-XF and Lunasin.

The overall objectives of the Feasibility include a full analysis of the technical and business potential of the Sulipro therapeutic. Throughout the duration of the project, Natural Shield expanded its knowledge of the NAFLD and NASH industry, therapeutic advancements and in particular the European market.

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

During the feasibility investigations, Natural Shield established that in order to achieve the target capacity, and the commercialization capacity the technology must be optimised and its safety profile extensively proved in in vivo validation studies. A strategic plan will minimize R&D costs by collaborating with strong partners – Like CMO Capsugel who will perform the clinical studies. Natural Shield’s innovative therapeutic, with its competitive advantages, puts the Company in a strong position and raise the bar for targeted therapies that can prolong the life of the patients with liver disease without harsh side effects. It is crucial that Natural Shield advances its current technology and commercial readiness levels to experience significant growth and development in the following years. A successful demonstration of the technology will help overcome the negative impact left on the industry by previous Natural supplements and will be fundamental to the potential growth of the company in both Europe and globally.

As a conclusion to the business feasibility assessment, Natural Shield have determined that Sulipro is the source of a viable commercial application, and that it has the potential to efficiently provide a long term treatment to a currently underserved market. Thanks to the feasibility study, Natural Shield have been able to identify the main customers for the product and also identify what potential customer’s desire from the solution. This is proven by the market research results and detailed customer analysis. The feasibility assessment also allows Natural Shield to develop a clearer and more suitable business model based on progress recently made which has advanced the company’s capabilities and will allow them to play a more prominent role after commercialisation than had previously been envisioned.

Considering the overall results of the Phase 1 assessment, it has been deemed worthwhile to follow up with the implementation of the product development and subsequent commercialisation plan. To successfully bring the drug to commercial readiness, Natural Shield will need further funding to carry out the remaining objectives. Following a careful assessment of all aspects pertaining to the project, Natural Shield concluded that the non-dilutive SME Instrument Phase 2 funding would provide the correct amount of funding and support to allow the implementation activities to be performed in the most suitable conditions. This will advance Natural Shield’s innovative therapeutic in its market position and penetration. Natural Shield will therefore be applying for the Phase 2 funding. Co-funding will be provided by Natural Shield’s own financial and operational capacity as well as grants received to date. Completing the activities outlined for Phase 2 will ensure that Natural Shield can introduce their product to the market immediately after the project ends.

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)

NatShield’s innovation project to treat fatty liver disease will bring several societal benefits to the EU, mostly related to health. Obesity is fuelling an epidemic in fatty liver disease in the EU. In the UK, liver disease rates have increased by 400% since the 1970s, whilst in the US liver transplants related to NAFLD and NASH have increased by 170% in a decade. It is predicted that the EU will see a similar trend in the very near future. NAFLD increases the risk of cirrhosis, liver cancer and death, placing significant strain on healthcare services. These upward trends are mirrored globally. For example, the Asia-Pacific region is one of the fastest growing markets for NASH, with an increasing prevalence of NAFLD in densely populated countries such as China, Japan and Korea. SULIPRO addresses the European Health Challenges, which intend to: 1) improve our ability to monitor health and to prevent, treat and manage disease; 2) test and demonstrate new therapeutics for health and care delivery and 3) reduce the enormous pressures and costs put on the EU health care system.

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