Thursday , July 29 2021

VALBIOTIS announces an additional scope for VALEDIA: Prevention of NASH

Regulatory News:

This press release contains multimedia elements. See the full press release here:

(Graphics: Work Wires)

(Graphics: Work Wires)

VALBIOTIS (FR0013254851 – ALVAL / appropriate PEA / SME),
French Research and Development company engaged
scientific innovation for prevention and control
metabolic diseases
announces a new scope
VALED to®Extends to NASH's prevention2nd. this
The new scope is based on a series of results
Today appeared to show clinical potential
revision of non-alcoholic fatty liver disease to prevent
NASH. They allow Phase II clinical trials to be initiated
Target, in addition to ongoing work for risk reduction
This new application of Type 2 diabetes strengthens VALEDIA®
status as a leading product for new strategies
Prevention of serious metabolic diseases
Risk factors for these diseases. In addition to prediabetes,
VALED to® The topics intended would be the first product
hepatic steatosis, early stage
Metabolic liver or NAFLD3before severe stages
Like NASH. Now it is estimated that these metabolic disorders are present.
Affects and expands 25% of the world's population4.

Research conducted by Leiden University (The Netherlands)
A scientific partnership framework showed a complete revision
Hepatic steatosis with the active substance of VALEDIA®,
TOTUM-63 in a model in vivo NAFLD.

In parallel, studies in vivo emphasize a mechanism
TOTUM-63's action to 3 key cellular targets between
Pathophysiology of NAFLD: Factors
β / ∂ P transcript, FXR and Fsp27 protein. cluster
The study details the action mechanism related to this prevention mechanism.
liver metabolism and is currently being presented at the Congress
American Society for the Study of Liver Diseases (AASLD), 9
In San Francisco on November 13, 2018 (poster No. 1827F).

Finally, additional results from the Phase I / II clinical trial
In 2017, the TOTUM-63 has been
Improved lipid profile including reduced ratios
blood cholesterol and triglycerides. This results in the profile
enhances lipidic positive data
insulin sensitivity. Lipid profile and
Insulin resistance is known for their strong involvement.
appearance and progression of hepatic steatosis.

This results for the first time today
From the research program carried out to date under the name of VAL-63

VALED to®, a global product
Prevention of type 2 diabetes and NASH from 2021

When clinical development is completed
prediabetrik, VALEDIA® marketable
a health claim to reduce the risk of developing diabetes
Type 2 until 2021. Beyond this first indicator,
marketing, VALEDIA® can also be recommended
to steatosis by health professionals
hepatic without prediabetes. This recommendation
The foundation of the first clinical data of development
VALED to® on steatosis.

In the second step, to obtain a specific health claim,
To reduce hepatic steatosis and reduce the risk
The NASH will be targeted as early as 2023.
all of this unstable steatotic population, prediction
According to the community, 13.3% of the general population in the United States and 4.5%

Projected business model for VALEDIA® an agreement
license with one or more health actors depending on regions
first payment (in advance), including installment
Milestones and copyrights in sales.

Phase II clinical development of VALEDIA® for
Risk reduction will begin with a Phase IIA study.
randomized and placebo controlled. Should be launched in 2019
in a target population with non-hepatic steatosis
Alcoholic, with the reduction of steatosis as the main criterion.
The first will be evaluated by the evolution of steatosis and its development.

Professor Samy HADJADJ, diabetologist and endocrinologist at Nantes University Hospital
comments: "
NAFLD and NASH pathologies
in people who often suffer today
associated metabolic disease or metabolic disorder
insulin resistance. Considering especially poor prognosis
NASH has been established to date with the exception of treatment
In the most advanced stage of liver transplantation, there is a real need
Effective reduction of steatosis stage
liver oil. VALEDIA results on this criterion
®so far obtained, extremely promising, allows
correction of steatosis
fat. If this experimental result is confirmed by clinical trials
VALEDIA in people
® may constitute a
A real appeal to people at risk of developing NASH. "

Valbiotis Chairman Sébastien PELTIER says: "VALED to®

Both new dimensions described today
it is consistent for the recycling of hepatic steatosis. This challenge
Ambitious: We make the choice to pick it up
potential of a product with the potential to meet, with a mechanism
exuberant action, unquestionable preclinical data and
first stimulating clinical symptoms. This new development
® this is a pioneering product
Global positioning for prevention in wide area
metabolic diseases related to insulin resistance. VALED to

today promises unique and powerful: to be "backbone"
Prevention of metabolic diseases and meeting their needs
A population at risk of developing Type 2 diabetes and / or
. "

Details of the new results of TOTUM-63, active principle
VALED & # 39; from
®lean liver disease

1. Full reversion of hepatic steatosis in models
steatosis has already been declared

As part of a research partnership with the University of Leiden,
In one study, the effectiveness of TOTUM-63 was evaluated in a model. in vivo
Previously, a strong steatosis developed in the liver. In this
"reversion" study, the addition of the active substance of VALEDIA®
Steatotic liver condition was restored every 4 weeks.
disappearance of steatosis is shown.
associated with return of histological and insulin sensitivity
HOMA-IR) to check the values.

Bruno Guigas, Researcher and Assistant Professor at the University
Leiden (Netherlands)
He conducted this work and detail these results : "
We have done analysis on all parameters
Histological, biochemical and physiological properties of hepatic steatosis

: They all are very close to an event show
A significant amount of TOTUM-63 for the recycling of steatosis. At this point
development, the results are indisputable and even
spectacular. "

2. a mechanism of action on 3 basic cellular targets,
prevention of hepatic steatosis

In a model in vivo Completion by NAFLD, TOTUM-63
16 simultaneously taking a high-fat diet
weeks of severe liver steatosis prevented the onset of
incomplete models. Examination of the mechanism of action
revealed a significant increase in active substance expression
Ppar ß / ∂ (multiplied by 3) and FXR (+ 30%), two factors
Key transcription of hepatic energy metabolism. In parallel
TOTUM-63 almost completely inhibits gene expression of protein
Fsp27 which regulates lipid storage and expresses itself particularly
steatotic liver.

This movement mechanism focused on the control of hepatic metabolism
is a powerful entity against fatty liver disease and
Reducing the risk from the early stages of NASH.

3. Significant improvement in lipid profile in humans,
total cholesterol and triglycerides

Phase I / II clinical study carried out within the scope of TOTUM-63 in 2017
Presence of VALEDIA®had already confirmed in healthy man
Improved insulin sensitivity. New results
The previously reported lipid profile is
Significant decrease in blood cholesterol levels (-5.5%)
and triglyceride (-18.5%) from the first 2.5 g / day dose tested.
Blood LDL-cholesterol not elevated
(-7.3%, 2.5 g / day, p = 0.07, -7.4%, 5 g / day, p = 0.08),
is currently a negative event for active content
FXR is moving on the channel. Insulin resistance and dyslipidemia
is strongly associated with the development of steatosis
NASH after hepatic.


A great need for prevention against the epidemic of NAFLDs

Globally, the prevalence of NAFLDs will be greater than 25%.4.
Patients are estimated to be between 50% and 70%.
diabetes560% to 75% of obese individuals and 50% of subjects
dyslipidemic6. Diabetes associated with pandemic and
Obesity, the number of cases in countries is constantly increasing
industrialized countries: projections are awaiting + 21% growth
Non-alcoholic fatty liver disease for NASH and + 63%
2030 Horizon7.

Fatty Liver Index: applicable fatty liver monitoring
routinely by the treating doctor

This is one of the difficulties in the clinical evaluation of liver disorders
It lies in the applications required for liver biopsy. However,
There are scores based on existing exams and have the advantage
Be easily accessible in general practice. This is the case
Fat Liver Index (FLI) calculated from 4 measurements taken
Routine: blood triglyceride level, Mass Index
Body, Gama Glutamyl Transferase (GGT) blood test and
waist circumference measurement. FLI may be an indirect sign
Used for liver steatosis and screening and tracking
Patients with suspected steatosis8. between
non-invasive imaging techniques are available and
have the advantage of being cheap and repeatable9.

NASH: severe and advanced fatty liver

Hepatic steatosis refers to the accumulation of fats.
liver cells. NASH and inflammation
tissue damage. Often with a dark prognosis, – 38% survival
10 years, NASH can progress to fibrosis and cirrhosis,
The cause of liver failure and in some cases
liver cancer10.

Current studies estimate 40% of people.
Liver steatosis will advance to NASH11th. this
Hepatic steatosis is at risk of developing.


VALBIOTIS is a French Research and Development company.
Scientific innovation, prevention and control
against metabolic diseases. Products intended for
Agriculture and pharmaceutical industry.
VALBIOTIS intervenes especially for the prevention of type 2 diabetes,
NASH (non-alcoholic steatohepatitis), obesity and
cardiovascular pathologies.

Founded in La Rochelle in early 2014, the company has established numerous companies.
To establish partnerships with academic centers in France and
University of La Rochelle, including CNRS and the University abroad
Clermont Auvergne is located in Clermont-Ferrand. These deals allow him
benefit from its creativity thanks to a strong leverage effect
Especially experts and technical partners
projects. The company is located on 3 sites in France – Périgny, La
Rochelle (17) and Riom (63) – plus an American office
Boston (MA).

"BPI Excellence" network member and taking advantage of the BPI label "
Innovative Company ", VALBIOTIS also has status" Young
Innovative Company "and received significant financial support
European Union, reaching research programs
European Regional Economic Development Fund (ERDF).

All information about VALBIOTIS:
: //

ISIN code: FR0013254851
Mnemonic code:

one Work carried out by
NAFLD Mouse Models on Leiden University (Netherlands)
NASH: No Alcoholic Stetohepatitis, English equivalent
non-alcoholic steatohepatitis
3 NAFLD: Alcohol-free
Fatty Liver Disease, non-alcoholic liver disease
Younossi Z.M. et al. Hepatology, 2016
5 Anstee, Targher
et al. 2013
6 Assy, Kaita et al. 2000
Estes C. et al., Hepatology, 2018
8 Bedogni G., BMC
Gastroenterology, 2006
9 Papagianni M et al. World J
Hepatol 2015; 7 (4): 638-648
10 World Gastroenterology
Global Guidelines Organization. Non-alcoholic fatty liver disease and
Non-alcoholic Steatohepatitis.
McPherson S et al. J Hepatol 2015; 62 (5): 1148-55
Vizuete J et al. J Clin Transl Hepatol 2017; 5 (1): 67-75

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