TOTUM•448: non-alcoholic fatty liver disease

TOTUM•448 is a unique patented combination of plant extracts, specifically designed to inhibit the storage of fat in the liver and to reduce blood and hepatic triglyceride levels.

Overview

Non-alcoholic steatotic hepatitis or NAFLD (non-alcoholic fatty liver disease) is part of a spectrum of liver diseases that range from a simple isolated steatosis (“fatty liver”) or NAFL (non-alcoholic fatty liver) to NASH (non-alcoholic steatohepatitis). NAFL is characterized by the accumulation of triglycerides in the liver. It is a risk condition for NASH, which strongly increases the risk of cirrhosis and hepatocellular carcinoma, and has a very low survival rate. The close ties between these diseases and metabolic disorders, obesity, insulin resistance, dyslipidemia, type 2 diabetes and arterial hypertension, have led the international scientific community to recently coin the term “metabolic-associated fatty liver disease” or MAFLD.

According to the World Gastroenterology Organisation, 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. To date, no therapeutic or preventive treatment has proven its efficacy and is available to treat these hepatic disorders.

Sources:
– World Gastroenterology Organisation Global Guidelines;
– Non-alcoholic Fatty Liver Disease and Non-alcoholic Steatohepatitis, 2012;
– Younossi et al. Hepatology, 2016 ; Williams et al., Gastroenterology, 2011;
¹Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis; World Gastroenterology Organization, 2012;
²EASL–EASD–EASO 2016 Clinical Practice Guidelines on the management of non-alcoholic fatty liver disease. J Hepatol 2016.

Key figures

38% survival rate at 10 years: the current prognosis for NASH patients.

Source: World Gastroenterology Organisation Global Guidelines.

40% of patients with non-alcoholic fatty liver disease (NAFL) will develop NASH and potentially other diseases within 8 to 13 years.

Source: EASL-EASD-EASO 2016 Clinical Practice Guidelines for the Management of Non-alcoholic Fatty Liver Disease. J Hepatol 2016.

Active substance

The active substance TOTUM•448 is a unique patented combination of plant extracts, designed to reduce non-alcoholic hepatic steatosis, a risk condition for NASH (“fatty liver disease”).
TOTUM•448 results from preclinical research on metabolic disease models, and aims at inhibiting fat storage in the liver and reducing blood and hepatic triglycerides.

Clinical development

A Phase II clinical study will be launched in the second half of 2021 to demonstrate the efficacy of TOTUM•448 in subjects presenting non-alcoholic hepatic steatosis.

Intellectual property

Valbiotis has adopted a global strategy to protect its intellectual property. Patent applications have been filed for TOTUM•448 in 61 countries, including key markets: Europe, USA, Canada, China, Russia, Japan, Brazil and Australia.

Patents have already been issued in 48 countries, including in the USA, Europe (39 countries), China and Russia, providing a very high level of protection.