TOTUM-448

NAFL, NASH: new epidemics requiring new preventive measures

Metabolic liver diseases are becoming a major public health issue worldwide. They are closely linked to the development of type 2 diabetes and obesity in the population.
NAFL (non-alcoholic fatty liver), is characterized by the accumulation of triglycerides in the liver. It is a risk condition that can develop into NASH (non-alcoholic steatohepatitis). This disease strongly increases the risk of cirrhosis and hepatocellular carcinoma and has very low survival rates.

According to the World Gastroenterology Organization, the prevalence of NAFL and NASH has doubled in the last 20 years. Today, NAFL affects 20 to 26% of the population in Europe and 20 to 46% of the population in the United States.
There is currently no therapeutic or preventive treatment with proven efficacy available for these hepatic disorders.

 

Sources: World Gastroenterology Organization Global Guidelines,
Non-alcoholic Fatty Liver Disease and Non-alcoholic Steatohepatitis, 2012;
Younossi et al. Hepatology, 2016;
Williams et al., Gastroenterology, 2011.

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Key figures

Prognosis

38%

chance of surviving 10 years: this is the current prognosis for patients with NASH.

Source: WGO Guidelines, 2012.

A risk condition

Up to 40%

of subjects with non alcoholic fatty liver (NAFL) will at least develop NASH within 8 to 13 years.

Source: EASL-EASD-EASO 2016 Clinical Guidelines on the management of non-alcoholic fatty liver disease. J Hepatol 2016.

TOTUM-448: a candidate to reduce the risk of NASH

The active substance TOTUM-448 is a patented combination of food plant extracts, designed to reduce non-alcoholic hepatic steatosis (or fatty liver), a risk condition for NASH.

TOTUM-448 results from intensive research on preclinical models of metabolic diseases, aiming at inhibiting fat storage in the liver and reducing blood and hepatic triglycerides.

Clinical Phase II development pending

A Phase II clinical study is planned to be launched during the second semester 2021. The objective will be to demonstrate the efficacy of TOTUM-448 in subjects with non-alcoholic hepatic steatosis. 

Intellectual property

Patent applications have been filed for TOTUM-448 in more than 60 countries, including key territories: Europe, USA, Canada, China, Russia, Japan, Brazil, Australia.

The patent was granted in France in 2014, in the United States in 2018, in Europe in 2019 (39 countries), in Russia in 2020 with a high level of protection.

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