TOTUM•448: non-alcoholic fatty liver disease

Designed to inhibit the storage of fat in the liver and to reduce blood and hepatic triglyceride levels.
Clinical development: Phase II pending.

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

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

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.

TOTUM•448: to reduce hepatic steatosis

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.

Phase II clinical study pending

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 more than 40 countries, including in the United States, Europe (39 countries) and Russia, providing a very high level of protection.