Final development, clinical validation and launch preparation of NL01, an innovative health ingredient for supplements, food products and foods for special medical purposes

Project Information

NUTRI-NEED

Grant agreement ID: 811592

DOI

10.3030/811592

Project closed

EC signature date 29 June 2018

Start date 1 June 2018

End date 31 May 2020

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 3 567 000,00

EU contribution

€ 2 496 900,00

Coordinated by

NUTRILEADS BV
Netherlands

Periodic Reporting for period 2 - NUTRI-NEED (Final development, clinical validation and launch preparation of NL01, an innovative health ingredient for supplements, food products and foods for special medical purposes)

Reporting period: 2019-06-01 to 2020-05-31

Summary of the context and overall objectives of the project

People want to live a long and healthy life and there is a huge demand for food products to enable this. Among consumers, the most desired health benefits in food products and supplements are ‘supports immune function’ and ‘increases resistance to infections’. NutriLeads is developing crop-derived food ingredients with clinically proven health benefits. With its proprietary lead ingredient NL-01 (brand name Xtramune™), having completed preclinical data and proven safety in humans, NutriLeads is on track to become the first company to launch an ingredient with an approved health claim for supporting immune function and increasing infection resistance. Targeted end-users of Xtramune™ containing food products (dietary supplements, medical- and functional foods) are children, young adults, adults, elderly and patients, aiming to support their health and immune status. Nutrileads selected a common crop from which Xtramune™ can be isolated, a game-changer for its commercial success, and developed the isolation process for Xtramune™ up to small scale industrial plant production. In this project, Nutrileads will perform medium scale-up of the production process to 250 kg. Nutrileads will complete the data package for Xtramune™ with a clinical study in a relevant population with increased infection risk to support the health claims on Xtramune™, register Xtramune™ as ‘Novel Food’ and obtain regulatory advice on registration as ‘Food for Specific Medical Purposes’. NutriLeads will generate revenues from out-licensing Xtramune™ to large companies in the food industry. Market leaders like Abbott, Nestlé, Friesland Campina, Danone, Fresenius regularly in-licence components for inclusion in their products.

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

The production process of Xtramune™ has been upscaled and optimized in collaboration with a toll manufacturer. Overall five core batches have been produced to determine specifications, batch to batch consistency, stability test have been initiated and test articles were produced for the clinical trial in a susceptible population. The protocol for this trial was approved by the relevant ethical committees and the clinical phase was successfully completed. A series of preclinical studies were done to further elucidate the mode of action. An ‘article 4 request’ was submitted for consultation to the competent national authority in Ireland (Food Safety Authority Ireland), which confirmed that Xtramune™ is considered novel foods. Drafting of the novel foods dossier is currently ongoing. Based on many discussions, we have put together a short list of ingredient suppliers and brand owners, that have shown the great interest and momentum, to continue the discussions about a potential partnership.

Outside of the current project, Nutrileads successfully completed a clinical trial in healthy volunteers, which prompted an amendmet of the grant agreement to ensure optimal alignment of this project with the fastest route towards value creation. During the reporting period, Nutrileads was selected as Rising foodstar of the EIT-food and is partner of the successful Funding Programme H2020 Marie Skłodowska-Curie ITN 2018 Sweet-crosstalk project.

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)

Among consumers, use of Dietary Supplements have become mainstream. Interest in Functional Foods is apparent, especially when delivering sought for desired health claims. Market has responded by making available over the last decade several types of food products, nutrient and ingredients with relation to immunomodulatory function (see below). The addressable market and user base is enormous, and continues to rise (see section 2). The time is now for health promoting foods and ingredients with truly clinically substantiated benefits. Especially in the current era of high informedness, and outspokenness of consumers and patients. None of the products on market reply to this; none are approved to carry the relevant health claims ‘supports immune function’ and ‘increases resistance to infections’.

NutriLeads has a specific focus on delivering science-proven health claims for its ingredients. This will allow to stand out, and truly differentiate in the market and towards its stakeholders. Strikingly, none of the currently marketed food products are sufficiently backed by convincing evidence, leading EFSA to reject all proposed claims on immune support for Functional Foods including those for market-leading prebiotic and probiotic products. This has created a huge market opportunity for Xtramune™.

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