VALBIOTIS SA: Valbiotis announces completion of recruitment for the Cardio-Liver clinical study conducted with TOTUM•448 for metabolic liver diseases (MASLD)

DJ VALBIOTIS SA: Valbiotis announces completion of recruitment for the Cardio-Liver clinical study conducted with TOTUM•448 for metabolic liver diseases (MASLD)

VALBIOTIS SA 
VALBIOTIS SA: Valbiotis announces completion of recruitment for the Cardio-Liver clinical study conducted with 
TOTUM.448 for metabolic liver diseases (MASLD) 
08-Dec-2025 / 17:40 CET/CEST 
Dissemination of a French Regulatory News, transmitted by EQS Group. 
The issuer is solely responsible for the content of this announcement. 
 
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Valbiotis announces completion of recruitment 
for the Cardio-Liver clinical study conducted 
with TOTUM.448 for metabolic liver diseases (MASLD) 

 -- The last volunteer was included in the Cardio-Liver study  All 70 participants have now been recruited in the 
  randomized, double-blind, placebo-controlled Cardio-Liver study; 
  
 
 -- Conducted as part of a research chair in partnership with Laval University (Quebec), this clinical study assesses 
  the effect of TOTUM.448 on multiple risk factors involved in the early stages of metabolic liver diseases (MASLD); 
  
 
 -- Results from the Cardio-Liver study will be available in the second half of 2026; 
  
 
 -- TOTUM.448 will already benefit upon market launch from a fully operational commercial ramp-up in France and from 
  resources already in place within the joint venture in Asia. 
  
 
La Rochelle, December 8, 2025 (5:40 PM CEST) - Valbiotis (FR0013254851 - ALVAL, PEA/PME eligible), a French laboratory 
specialized in the design and distribution of scientifically tested dietary supplements to support health at every 
stage of life, announces completion of recruitment for the Cardio-Liver clinical study, with 70 participants enrolled. 
The study will evaluate the effect of TOTUM.448 on multiple risk factors involved in the early stages of metabolic 
liver diseases (MASLD) and in particular MASH (formerly NASH). The results of the Cardio-Liver study will be available 
in the second half of 2026. 

The Cardio-Liver clinical study is a randomized, double-blind, placebo-controlled trial enrolling 70 participants with 
hepatic steatosis (without significant associated fibrosis) and who are overweight or obese. Participants are divided 
into 2 equivalent groups of 35 people, supplemented for 4 months with TOTUM.448 (4.28 g/day) or a placebo. The 
Cardio-Liver study evaluates not only the reduction of hepatic steatosis, a risk factor for metabolic liver diseases 
(MASLD), but also a large number of metabolic parameters linked to the development and worsening of this condition. 
This trial is expected to confirm the results already obtained in the bioavailability and mechanism-of-action clinical 
study, completed in the first quarter of 2025. 

A major study in this indication 

The Cardio-Liver trial stands out for the exceptional scale and depth of its clinical investigations. Conducted in 
partnership with a leading academic center, the study uses highly advanced measurement techniques to explore several 
levels of MASLD pathophysiology, a complex and multifactorial indication. Beyond the precise quantification of hepatic 
steatosis using advanced imaging, Cardio-Liver includes a comprehensive evaluation of cardiometabolic and inflammatory 
parameters, a detailed assessment of body composition, and an analysis of liver status by elastography. 

The study is also noteworthy for its integration of innovative approaches, including the study of gut microbiota and 
the analysis of different "omic" profiles carried out on blood samples and, for some participants, on liver biopsies. 
This rare level of investigation in a nutritional supplementation study provides a comprehensive and integrated view of 
the potential effects of TOTUM.448. It will make it possible to not only assess with unprecedented accuracy its impact 
on the many dimensions of MASLD, but also deepen the understanding of its pathophysiology, explore mechanisms of action 
that are still difficult to access and, where appropriate, identify innovative biomarkers that will strengthen the 
characterization and clinical relevance of this nutritional solution. 

Pascal Sirvent, Chief Scientific Officer PhD, HDR, member of the Board of Directors "The close of recruitment for the 
Cardio-Liver study marks a key milestone in the clinical development of TOTUM.448. We look forward to obtaining the 
data from this study, which will add to the already very positive results for this highly innovative active substance. 
We are glad to be able to strengthen the potential of our nutritional solution for managing hepatic steatosis, a 
growing concern within the population. This study supports our scientific approach and our resolve to deliver 
innovative products focused on supporting health and quality of life for people affected." 

Prof. André Marette, Principal Investigator of the study, Research Center of the Quebec Heart and Lung Institute 
(IUCPQ): "We are very proud to have completed recruitment for the Cardio-Liver study. This study will be conducted with 
great methodological rigor and features a robust experimental design with particularly sophisticated investigations. It 
will provide us with valuable information, particularly about the mode of action of this innovative active substance on 
hepatic steatosis." 

A scientifically validated product ready for rapid market launch in France and Asia 

TOTUM.448 already benefits from a solid level of scientific evidence, supported by several international reference 
publications highlighting the robustness of its efficacy and its good tolerability. Since 2022, eight presentations at 
several international congresses (including the European Association for the Study of the Liver and the American 
Association for the Study of Liver Diseases) have also shared with the scientific community highly convincing data on 
the efficacy and mechanism of action of this active substance. 
 
The results of the Cardio-Liver study will complete the clinical validation of TOTUM.448, paving the way for the 
development of a high-potential new product within the ValbiotisPRO range. This range currently includes three 
products (ValbiotisPRO Cholesterol, ValbiotisPRO Metabolic Health, ValbiotisPRO Cardio-Circulation) already in the 
commercialization phase. The market launch of TOTUM.448 will address the significant market for the prevention of 
metabolic liver diseases. 

Beyond market potential, the commercialization of this new product will lean in France on an extensive network of 
pharmacies and prescribers already fully engaged, as well as on a functional e-commerce platform. Internationally, the 
upcoming joint venture in Asia will also be a key asset for the successful commercial roll-out of TOTUM.448 in this 
strategic region, initially extending to several key markets (China, Hong Kong/Macau, Vietnam, Indonesia, Japan, Taiwan 
and Singapore). In other parts of the world, the commercial development of TOTUM.448 could benefit from future 
agreements with potential partners. 

Metabolic liver diseases: epidemiological data 
 
Worldwide, nearly 1 billion adults are estimated to have a metabolic dysfunction-associated steatotic liver disease 
(MASLD)1. The vast majority are affected by the first stage, simple hepatic steatosis, a risk factor for developing 
MASH (metabolic dysfunction-associated steatohepatitis). As with all metabolic disorders, acting at an early stage 
helps prevent progression to a more severe condition requiring drug intervention and difficult to reverse. 

These metabolic liver disorders affect mainly individuals who are overweight or obese, often combined with an 
unbalanced lifestyle. A diet high in fats and sugars, sedentary habits and lack of regular physical activity all 
promote the accumulation of fat in the liver. Globally, an estimated 2.5 billion adults2 (aged 18 and over) are 
overweight, meaning one in two adults, and around 900 million people currently live with obesity. This population is 
particularly at risk of developing diseases such as hepatic steatosis, making these conditions a major public health 
issue. 

1. Guo Z., Wu D., Mao R., Yao Z., Wu Q., Lv W. Global burden of MAFLD, MAFLD-related cirrhosis and MASH-related liver 
cancer from 1990 to 2021. Scientific Reports. 2025.   
 
2. World Health Organization (WHO), in 2022. 

About Valbiotis 
 
Valbiotis is a French laboratory specializing in the creation and distribution of dietary supplements scientifically 
tested to maintain health at every stage of life. Through an innovative approach combining scientific excellence, plant 
expertise and a wealth of natural ingredients, Valbiotis offers a new generation of dietary supplements to support 
cardio-metabolic balance and well-being, and address everyday health issues such as sleep, fatigue, mood management, 
immunity and vitality. Created at the beginning of 2014 in La Rochelle, France, Valbiotis has forged numerous 
partnerships with leading academic centers. 
 
Valbiotis is a member of the "BPI Excellence" network and has been recognized as an "Innovative Company" by the BPI 
label. Valbiotis has received major financial support from the European Union for its research programs via the 
European Regional Development Fund (ERDF). Valbiotis is a PEA-SME eligible company. 
 
For more information on Valbiotis, please visit: www.valbiotis.com 

Contacts 
 
Corporate Communication / Valbiotis 
 
Caroline LAMBERTI 
 
+ 33 6 77 82 56 88 
 
[e-mail] 

Financial Communication / Seitosei.Actifin  
 
Marianne PY 
 
[phone] 
 
[e-mail] 

Press Relations / Seitosei.Actifin  
Anne-Claire TATON 
 
[phone]  
 
[e-mail] 

Name: Valbiotis 
ISIN Code: FR0013254851 
 
Ticker Symbol: ALVAL 
 
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