Business Wire

VALBIOTIS

7.6.2019 07:37:06 CEST | Business Wire | Press release

Share
VALBIOTIS to Present Novel Data about TOTUM-63 and Metabolic Diseases Prevention at the 2019 Scientific Sessions of the American Diabetes Association

Regulatory News:

VALBIOTIS (Paris:ALVAL) (FR0013254851 – ALVAL / PEA/SME eligible), a French Research & Development company committed to scientific innovation for the treatment and prevention of metabolic diseases, today announced that new preclinical results of TOTUM-63 obtained independently by Leiden University (Netherlands) will be presented at the 2019 scientific sessions of the American Diabetes Association, being held from June 7 to 11 in San Francisco, California. In a murine model of prediabetes, TOTUM-63 reduced inflammation in visceral adipose tissue, one of the pathophysiological mechanisms of metabolic diseases, especially type 2 diabetes. Moreover, this study also confirmed the efficacy of TOTUM-63 on sugar and lipid metabolism in this preclinical model.

"This study from Leiden University is important from a scientific standpoint: it demonstrates a new effect of TOTUM-63, the active substance of lead product candidate VALEDIA ® , on visceral adipose tissue inflammation that enriches the multi-target mode of action of TOTUM-63. On the clinical side, as previously announced, we expect to report the results of the international Phase IIA clinical study of VALEDIA ® before July 31 st ," comments Sébastien PELTIER, CEO of VALBIOTIS.

Anti-inflammatory action on visceral adipose tissue

"Obesity, in both humans and mice, leads to an increase and an activation of macrophages in visceral adipose tissue. These immune cells are involved in maintaining a silent metabolic inflammation, thus reducing the body's ability to use insulin. By reducing this inflammation and increasing insulin sensitivity in adipose tissue, TOTUM-63, the active substance of VALEDIA ® , would contribute to the reduction of the release of lipids into the bloodstream," specifies Dr. Bruno GUIGAS, researcher at Leiden University (Netherlands), the lead investigator of the study.

The discovery of this new effect further enriches the multi-target mode of action of TOTUM-63, which was presented at the European Association for the Study of Diabetes (EASD) congress in 2018. This mode of action would already combine the preservation of the pancreas, the improvement of insulin signaling in the muscle and the adipose tissue, the reduction in hepatic steatosis and an improved composition of the intestinal microbiota.

About TOTUM-63, the active substance of VALEDIA ®

Prediabetes is a growing public health issue worldwide that has been acknowledged by international organizations. Without appropriate management, 70% to 90% of prediabetic subjects will develop type 2 diabetes.

VALEDIA® intend to be the first natural and clinically proven solution specifically designed for prediabetics. VALEDIA® contains the active substance TOTUM-63, a unique and patented combination of 5 plant extracts, with high potential to target the physiopathological mechanisms of type 2 diabetes.

The launch of VALEDIA® is planned for 2021, with a health claim for reducing the risk of type 2 diabetes.

TOTUM-63 has already been proven safe and effective in healthy human volunteers during a Phase I/II clinical study. The results of the first international Phase IIA study are expected before 31 July 2019.

ABOUT VALBIOTIS

VALBIOTIS is a French Research & Development company committed to scientific innovation for the treatment and prevention of metabolic diseases. Its products are made for major players in the health care sector. VALBIOTIS particularly focuses on solutions to prevent type 2 diabetes, NASH (nonalcoholic steatohepatitis), obesity and cardiovascular diseases.

VALBIOTIS was founded in La Rochelle in early 2014 and has formed numerous partnerships with top academic centers in France and abroad, including La Rochelle University, the CNRS and Clermont Auvergne University located in Clermont-Ferrand. These partnerships have enabled Valbiotis to benefit from strong financial leverage, particularly thanks to experts and technical partners who support its projects. The Company has established three sites in France – Périgny, La Rochelle (17) and Riom (63) – and an American office in Boston (MA).

VALBIOTIS is a member of the "BPI Excellence" network and received the "Innovative Company" status accorded by BPI France. Valbiotis has also been awarded "Young Innovative Company" status and has received major financial support from the European Union for its research programs by obtaining support from the European Regional Development Fund (ERDF). VALBIOTIS is a PEA-SME eligible company.

Find out more about VALBIOTIS:
http://valbiotis.com/

Name: VALBIOTIS
ISIN code: FR0013254851
Mnemonic code: ALVAL

Disclaimer

This press release contains forward-looking statements about VALBIOTIS' objectives, based on rational hypotheses and the information available to the company at the present time. However, in no way does this constitute a guarantee of future performance, and these projections can be reconsidered based on changes in economic conditions and financial markets, as well as a certain number of risks and doubts, including those described in the VALBIOTIS core document, filed with the French Financial Markets Regulator (AMF) on 5 April 2017 (application number I.17-012), as well as in the 2017 annual financial report, filed with AMF on 3 April 2018. This press release, as well as the information contained herein, does not constitute an offer to sell or subscribe to, or a solicitation to purchase or subscribe to, VALBIOTIS' shares or securities in any country.

Contact:

VALBIOTIS CORPORATE COMMUNICATION Carole Rocher / Marc Delaunay +33 5 46 28 62 58 medias@valbiotis.com

FINANCIAL COMMUNICATION ACTIFIN Stéphane Ruiz +33 1 56 88 11 14 sruiz@actifin.fr

MEDIA RELATIONS MADIS PHILEO Guillaume De Chamisso +33 6 85 91 32 56 guillaume.dechamisso@madisphileo.com

UNITED STATES SOLEBURY TROUT Rebecca John / Patrick Till +1 646 378 2935 rjohn@troutgroup.com ptill@troutgroup.com

Link:

ClickThru

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Angelini Pharma and Quiver Bioscience Announce Strategic Research Collaboration and Licensing Agreement to Discover and Advance Novel Therapeutics for Genetic Epilepsies23.2.2026 14:08:00 CET | Press release

Angelini Pharma secures exclusive global license rights to future identified drug targets Quiver receives undisclosed advance payment and is eligible for future milestone-dependent payments and royalties Collaboration further expands Angelini Pharma’s focus on brain health, building on its deep therapeutic expertise and drug development experience Angelini Pharma, part of the privately owned Angelini Industries, and Quiver Bioscience (“Quiver”), a discovery technology and therapeutics company advancing programs for the treatment of central nervous system (CNS) disorders, announced today that they have entered into a collaboration and licensing agreement to advance novel therapeutics for genetic epilepsies. The collaboration brings together Quiver’s unique drug discovery capabilities, data assets, and AI models with Angelini Pharma’s established expertise in brain health and epilepsy drug development. This press release features multimedia. View the full release here: https://www.busine

Armis Achieves U.S. Department of Defense Impact Level 5 Authorization23.2.2026 14:00:00 CET | Press release

DoD customers can now leverage Armis Centrix™ with enhanced security controls and connectivity Armis, the cyber exposure management & security company, today announced that it has achieved authorization from the U.S. DoD’s Defense Information Systems Agency (DISA) to operate at an Impact Level 5 (IL5). This means that Armis has met strict requirements to manage and secure the DoD’s critical infrastructure, including Controlled Unclassified Information (CUI) systems. “We are committed to helping Federal agencies like the Department of Defense address their toughest cybersecurity challenges,” said Alex Mosher, President and CRO at Armis. “Achieving DISA IL5 authorization is an important milestone for Armis as we continue to support DoD customers in safeguarding critical systems, sensitive data and national security infrastructure from evolving cyber threats.” Armis empowers Federal agencies to build and optimize comprehensive cybersecurity programs with Armis Centrix™, the FedRAMP and DI

IQM, a Global Leader for Quantum Computing, to Become the First Listed European Quantum Company, Through Merger with Real Asset Acquisition Corp.23.2.2026 13:49:00 CET | Press release

Global commercial leader with 21 systems sold to 13 customers to date – including 4 out of the top 10 supercomputing centres globally. Industrial leader with 15 systems delivered (largest number publicly disclosed by selected quantum companies1), 30+ computers built, own chip factory and quantum data centre. The transaction values IQM at a pre-money equity valuation of approximately USD 1.8 billion and makes IQM the first European quantum company to go public. With the close of this transaction, IQM’s cash position expected to exceed USD 450 million.2 Significant business momentum, with at least USD 35 million3 2025 revenue (unaudited) and over USD 100 million bookings / visibility as of year-end 2025. Strong commercial integrations with high-performance computing and enterprise platforms across the quantum/AI value chain such as NVIDIA, Hewlett Packard Enterprise, AWS, Toyo Corporation and Bechtle AG. Technical successes, achieving greater than 99.9% fidelity for single-qubit and two-

Organon Enters into Agreement to License MIUDELLA®, Sebela Pharmaceuticals’ Hormone-Free Intrauterine Device23.2.2026 13:30:00 CET | Press release

MIUDELLA® is a strategic addition to Organon’s portfolio, strengthening its long‑term commitment to advancing women’s health Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, announced today that it has entered into an agreement to exclusively license global rights to MIUDELLA, Sebela Pharmaceuticals’ hormone-free copper intrauterine device (IUD) contraceptive. The effectiveness of this transaction is subject to review under the Hart-Scott-Rodino Antitrust Improvements Act and to U.S. Food and Drug Administration (FDA) approval of MIUDELLA's alternate supply chain entities and certain other conditions. MIUDELLA, the first hormone-free copper IUD approved in the U.S. in the last 40 years, is complementary to Organon’s commercial capabilities and would further Organon’s commitment to building a portfolio of products that meet women’s diverse reproductive health needs. MIUDELLA was approved by the FDA on

Lenovo Unlocks Data Potential with Next Generation of AI-Driven ThinkEdge Solutions23.2.2026 12:00:00 CET | Press release

New ThinkEdge devices deliver scalable, rugged, and versatile intelligence from gateway to high-performance edge for real-time insights Lenovo™ expanded its ThinkEdge portfolio with a new generation of AI-driven edge computing solutions, including the compact and reliable ThinkEdge SE10n Gen 2, the AI-ready ThinkEdge SE30n Gen 2, the AI-powerhouse ThinkEdge SE60n Gen 2, and Lenovo’s first industrial all-in-one (AIO) Panel PC, the ThinkEdge SE50a. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260223166717/en/ ThinkEdge SE10n Gen 2 As enterprises push intelligence closer to operations to improve resilience, reduce latency, and keep sensitive data local, edge computing has become a critical layer between devices, infrastructure, and cloud. Lenovo’s ThinkEdge solutions are purpose-built, industrial-grade edge systems designed to run reliably in harsh, space-constrained environments where traditional servers or PCs are impractic

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye