Focusing on prevention rather than the cure; Newtricious – connecting science and well-being

Published: 04-02-2014, | Member: Newtricious

The promotion of a healthy lifestyle with a better diet and increased physical activity is of the utmost importance for future public health, well-being and prosperity around the world. The problem with the treatment of most high-cost, high-burden chronic diseases is the lack of a curative approach, as well as the limited possibility of modifying the course of the disease. Current treatments are often modestly effective, sometimes offering only temporary symptomatic relief. Chronic diseases are, in most cases, multifactorial; thus a single pharmaceutical agent might not be effective on its own. Since developing new drugs is extremely costly, researchers are paying more attention to the positive effects of Specialized Nutrition.

Managing these multifactorial chronic diseases requires a new and integrated approach that combines early diagnostics, specialized nutrition and medical care with a tailored lifestyle (diet nutrition and physical activity). The goals are more healthy years and a better quality of life.

More and more, scientists are viewing food products containing bioactive compounds—preferably from natural origins—as a significant option for early intervention in the prevention and initial treatment of major diseases. These so-called functional food products, or “nutraceuticals,” aim at maintaining health in risk groups, rather than treating an advanced disease (a common target of medicinal products).

While nutraceuticals—foods with health claims—are getting more and more interest based on their beneficial effects (reflected in the health claims), they are not comparable to drugs. These products are much more mildly acting, can be easily added to the diet and have almost nonexistent side effects. Therefore, they are placed in an emerging health intervention category between food and pharma which is often used to address the role of food in maintaining health.

Emerging legislation
The development of innovative pharma products follows a clear, well-defined pathway of clinical trials. Various authorities around the world have issued unambiguous guidelines for the evaluation and registration of such medicinal products.

In contrast, the development of dietary intervention products is not yet well defined. In the past five years, the European Food Safety Authority (EFSA) has reviewed more than 4,000 dossiers and health claims, resulting in more than 80% rejections—mostly because the claims weren’t strong enough.

For dietary intervention studies, it now seems appropriate to adopt the scientific principles of medicinal product development; however, a straight implementation is not possible because dietary intervention products do not target ill people and do not claim to be a cure. These products are based on naturally occurring substances (bioactives) and not on artificial compounds. They act mildly and the food matrix often has a profound supportive impact on the effect of the bioactive compounds. Therefore, we can view the development of functional food products that will pass the test of EFSA, FDA and other authorities as an emerging science.

Newtricious was founded in 2006 with the aim of developing innovative food products that contribute to better health and well-being. The company builds strong consortia of scientific institutes and innovative companies (both SMEs and multinationals) in which it has a connecting and steering role. The goal is to develop, jointly with other parties, a new generation of active food ingredients and products that can contribute to a better quality of life.

The most advanced programs are those that focus on NWT-02 and NWT-03, which target eye disease and cardiovascular illnesses, respectively.

Because of its innovative performance, Newtricious was awarded the prestigious Food Valley Award in 2008!

Cardiovascular health and NWT-03
Cardiovascular health is a very important topic around the world. In the USA, for example, atherosclerosis causes approximately 1.5 million myocardial infarctions and 200,000 deaths from stroke and brain infarction annually. In Europe, there are 4 million deaths each year from atherosclerotic disease, which accounts for nearly half of all deaths (48%).1

Another disease leading to a very high burden of vascular disorders is diabetes mellitus; it is estimated that worldwide, 55 million people have already developed type 2 diabetes, and a steep future increase is expected as a result of the obesity pandemic.2

NWT-03 is a natural product based on an enzymatically hydrolyzed protein from egg whites. It shows promising effects in in vitro experiments and in animal studies. In vitro effects include activity on ACE- and DDP-IV receptors, which are respectively associated with blood pressure and glycemic control. In laboratory animals with a high risk of developing certain diseases, this activity was confirmed as a way to maintain cardiovascular health (to be published shortly).

Researchers are currently performing a proof of principle study in human volunteers. If the activity profile is confirmed in humans, a dietary intervention study program in cardiovascular health maintenance will be started, with the objective of securing a health claim with FDA, EFSA and other regulatory authorities.

Age-related Macular Degeneration (AMD) and NWT-02
Age-related Macular Degeneration (AMD) is reducing the quality of life of our elderly population.

AMD affects the macula, a central specialized part of the retina responsible for fine detailed vision. Patients with advanced AMD lose central vision. Beyond its inevitable impact on the individual sufferer, AMD poses a growing economic challenge to modern society.3 AMD is the leading cause of blindness in developed countries.

In Europe, about 8.5 million people have severe forms of AMD;4 it is affecting 33 million people worldwide,5 and the prevalence and incidence of this condition continue to rise due to increasing longevity.6 AMD represents an unmet medical need; many people are not aware they suffer from it, and once they become aware there is no cure. There are no effective medicines on the market, nor are there any even close to market approval.

Newtricious has developed a chicken egg that is enriched with macular xanthophylls and omega-3 fatty acids—compounds that are thought to play an important protective role in the macula. The egg yolk plays a crucial role in achieving an excellent and consistent absorption of xanthophylls from the gut into the blood stream of human beings. Therefore, the product can be regarded as a food product with an enhanced bioavailability of xanthophylls.7 This program was described in a previous issue of Food for Thought.8 At that time, the project was in early stages of development. Since then, a beverage formulation has been developed that contains the enriched egg yolk, with the code name NWT-02.

Newtricious successfully completed a series of three clinical studies with NWT-02: two were investigations of different formulations (liquid and powder), and one was a comparative dietary intervention study of NWT-02 versus placebo in subjects with early signs of AMD. In this study, 100 individuals were recruited at the University Hospital Maastricht. The subjects used the allocated product (active or placebo) daily for one year, and researchers assessed several parameters regarding the condition of the macula and visual functions.

Soon a second, international dietary intervention study with a similar design will begin. These studies will be used as pivotal studies for the FDA, EFSA and other regulatory authorities for the submission of a dossier to secure a health claim.

In the meantime, the production of the NWT-02 beverage (liquid and powder) has been developed to an industrial scale and is being performed by well-reputed partners under strict HACCP and/or GMP regulations.

Newtricious’ product development gets strong financial support
Newtricious recently completed a first financing round with a consortium of investors, consisting of the Brabant Life Sciences Seed Fund (BLSF), the Industry Bank LIOF, Nedermaas High-tech Ventures and the innovation fund of the Limburg province. In addition, an Innovation Credit has been obtained from Agentschap NL (part of the Ministry of Economic Affairs, Agriculture & Innovation), and a credit was obtained from Rabobank Venray.

With these investment funds, Newtricious gets strategic partners in the company who fully support and will help develop its vision and strategy. They also provide the required financial strength and the possibility of accelerating the realization the company’s innovative development strategy, and bringing products to the market in collaboration with commercial partners—in order to make those products rapidly available for worldwide consumer consumption.

Scientific approach with strong partners
Newtricious has decided to adhere to the business model of a virtual company. This means that many elements are similar to those of a biotech company, for example. The main element making the company “virtual” is the fact that most of the work is being outsourced.

One of the core competencies is to establish jointly, with the right partners, a series of projects designed to lead to granted health claims in the USA, Europe and elsewhere.

With the ever-increasing requirements from food and health authorities like EFSA and FDA, Newtricious has developed high (pharma-like) standards for study design and study conduct, which have been adapted for use in dietary intervention studies. These standards were introduced in all development programs, and all partners do adhere to them.

Manufacturing is being performed by partners or subcontractors. The business model includes a strong package of patents and market registrations that enable commercial partners to reach a large number of individuals in the risk groups with Newtricious’ promising products.

Strong partners
In this network approach, it is of paramount importance that all collaborating parties have excellent capabilities in their own fields. Newtricious works with outstanding, globally leading academic groups in Europe and the USA. The same holds true for its corporate partners, whether they’re large multinationals with broad fields of interests, or small and medium enterprises with deep knowledge of a relevant scientific area or a state-of-the-art technological platform.

Newtricious is open to new partnerships with scientific institutes and innovative companies that share its vision. It is, therefore, in close contact with the network of Innovation Attachés of the Dutch embassies abroad. Newtricious is always looking for commercial partners that can bring products to the individuals at risk around the globe—both correctly (using granted health claims) and swiftly, since many people are waiting for effective, early interventions.

1 Datamonitor.
2 Datamonitor.
3 Gupta et al. Age-related macular degeneration: the costs to society and the patient. Curr Opin Ophthalmol 2007; 18(3):201-205.
4 Vingerling et al. The presence of age-related maculopathy in the Rotterdam study. Ophthalmol 1995; 102(2):202-210.
5 Feigl et al. The challenge of predicting macular degeneration. Curr Med Res Opin 2011; 27(9):1745-1748.
6 Congdon et al. Important causes of visual impairment in the world today. JAMA 2003; 290(15):2057-2060.
7 Chung et al. Lutein bioavailability is higher from lutein-enriched eggs than from supplements and spinach in men. J Nutr 2004; 134:1887-1893.
8 Taking on Age-related Macular Degeneration: Scientific collaboration supports entrepreneur Newtricious in the battle against elderly blindness.