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VALBIOTIS (EPA:ALVAL) VALBIOTIS SA: Valbiotis announces the major success of the phase II/III HEART II clinical study on LIPIDRIVE

Transparency directive : regulatory news

14/01/2025 17:44

VALBIOTIS SA
VALBIOTIS SA: Valbiotis announces the major success of the phase II/III HEART II clinical study on LIPIDRIVE

14-Jan-2025 / 17:44 CET/CEST
Dissemination of a French Regulatory News, transmitted by EQS Group.
The issuer is solely responsible for the content of this announcement.


 

 

 

 

Press Release

 

 

 

 

 

Valbiotis announces the major success of the

phase II/III HEART II clinical study on LIPIDRIVE® (active substance in Valbiotis® Pro Cholestérol): Proven efficacy in reducing LDL cholesterol in individuals with mild to moderate hypercholesterolemia

 

 

 

  • The study's primary endpoint was met, with a very significant difference vs. placebo in the reduction of LDL cholesterol (bad cholesterol) in individuals with mild to moderate hypercholesterolemia (p less than 0.01).
  • The Lipidrive® (formerly Totum•070) group showed a highly significant reduction in LDL Cholesterol after 3 months of supplementation, similar to that observed in the phase II HEART study.
  • The study also demonstrated Lipidrive®'s excellent safety and tolerability, and compliance exceeding 98%.
  • The clinical plan for Lipidrive® is now completely finalized, with over 300 patients included in the various clinical trials, which have unequivocally confirmed the efficacy and safety of the product, validating Valbiotis' scientific approach based on innovative combinations of plant active ingredients.

 

 

La Rochelle, January 14, 2025 (5:40 PM CEST) - Valbiotis (FR0013254851 - ALVAL, PEA / PME eligible), a French scientific research laboratory specialized in the marketing of dietary supplements scientifically proven to prevent metabolic and cardiovascular diseases and maintain optimal daily health, announces the broad success of the Phase II/III HEART II study on Lipridrive® (the active substance in Valbiotis® Pro Cholesterol). Carried out on 180 subjects with mild to moderate hypercholesterolemia, this international, multicenter, randomized, placebo-controlled study validates the efficacy of Lipridrive® at a dose of 5 g per day on the primary endpoint of lowering LDL cholesterol after 3 months of supplementation.

 

Once all the analyses have been completed, the full results of the HEART II study will be submitted for presentation at international congresses and publication in international peer-reviewed journals.

 

Jean-Marie Bard, Professor Emeritus of Biochemistry, Hospital Pharmacist, Science Officer for the HEART II Study explains: "Hypercholesterolemia is a major cardiovascular risk factor that affects millions of people. The HEART II and HEART clinical trials, involving over 300 people, demonstrate the efficacy of a red-yeast-rice-free, drug-free solution for the management of mild-to-moderate hypercholesterolemia with an unprecedented level of scientific and clinical evidence."

 

 

Sébastien Peltier, PhD, CEO and Co-Founder of Valbiotis: "We are proud to announce these positive clinical results, which mark the culmination of an exemplary phase of clinical development. This study is in full alignment with our objective of developing natural products with high scientific and clinical value that offer significant health benefits to patients in the prevention and early stages of metabolic and cardiovascular diseases. Our commitment to making a tangible contribution to public health is the driving force behind this determination."

 

 

 

 

 

 

About Valbiotis

Valbiotis is a French scientific research laboratory specializing in the marketing of scientifically validated dietary supplements that support optimal daily health and prevent metabolic and cardiovascular diseases. Valbiotis has adopted an innovative approach aiming to revolutionize healthcare by developing a new class of health nutrition products designed to reduce the impact of metabolic disorders and minimize cardiovascular risk factors. This approach relies on a multi-target strategy made possible with the use of marine and terrestrial, plant-based resources.

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

 

 

 

 

 

 

 

 

 

 

 

 

 

Press Contacts:

Corporate Communications:

Caroline Lamberti

Director of Communications and Public Affairs

+33 6 77 82 56 88

caroline.lamberti@valbiotis.com

 

Financial Communications:

Seitosei Actifin

Stéphane Ruiz

Associate Director

+33 1 56 88 11 14

stephane.ruiz@seitosei-actifin.com

 

Seitosei Actifin

Marianne Py

+33 1 80 48 25 31

marianne.py@seitosei-actifin.com

 

 

 


Regulatory filing PDF file

File: Communiqué de presse HEART II EN


Language: English
Company: VALBIOTIS SA
12F, Rue Paul Vatine
17180 Périgny
France
Phone: 0546286258
E-mail: contact@valbiotis.com
Internet: www.valbiotis.com
ISIN: FR0013254851
Euronext Ticker: ALVAL
AMF Category: Inside information / Other releases
EQS News ID: 2067663
 
End of Announcement EQS News Service

2067663  14-Jan-2025 CET/CEST

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