Business Wire

VALBIOTIS

Share
Valbiotis Announces the Positive Results of Its Clinical Study on the Bioavailability and Mode of Action of TOTUM•070, Against Hypercholesterolemia

Regulatory News:

Valbiotis (FR0013254851 - ALVAL, PEA-SME eligible), a Research and Development company committed to scientific innovation for preventing and combating metabolic and cardiovascular diseases, announces the positive results of its clinical study on the bioavailability and mode of action of TOTUM•070 against hypercholesterolemia.

This innovative protocol, involving 10 healthy volunteers, has first confirmed the presence of 22 metabolites2 of interest in the serum3 of volunteers. The analyses were conducted following oral administration of the clinical dose of 5g of TOTUM•070, used also in the Phase II HEART study. Most of the 22 metabolites are already known for their activity on metabolism. Mode of action analyses then demonstrated, among other things, two effects of TOTUM•070 on human liver cells: inhibition of the cholesterol synthesis pathway and inhibition of cholesterol storage in hepatocytes. These two effects on cholesterol in the liver, which is one of the main metabolic organs, speak in favor of TOTUM•070’s potential against hypercholesterolemia. Following on from these positive results, Valbiotis will announce the outcome of its Phase II HEART clinical efficacy study in the second quarter of 2022, as planned. Its primary endpoint is the reduction of blood LDL-cholesterol.

Pascal SIRVENT, Director of Discovery and Preclinical and Translational Research and Member of the Board of Directors, states: “For the first time, this clinical study has evaluated the bioavailability and hepatic mode of action of TOTUM•070 in humans. The results live up to our expectations: we can confirm that TOTUM•070 contains many metabolites of interest for regulating cholesterol. Most importantly, the results show that these metabolites are bioavailable in humans and have two significant effects on the regulation of cholesterol in the cells of the human liver, one of the main metabolic organs. These novel clinical data build on the positive preclinical results presented in 2021 and pave the way for further mode-of-action investigations in the liver. Above all, they confirm the potential of TOTUM•070 against hypercholesterolemia in humans, pending the imminent results of our Phase II clinical efficacy study.”

Murielle CAZAUBIEL, Director of Medical, Regulatory and Industrial Affairs and Member of the Board of Directors, adds: “During this clinical study on TOTUM•070, we used an innovative methodology adapted to our plant-based active substances that combines metabolomics and mode of action, which is now producing results. This is a positive clinical development and a very encouraging sign while we wait for the Phase II HEART clinical efficacy results, which will become available in the second quarter of 2022.”

Results of the clinical study on bioavailability and mode of action

This study was conducted on 10 healthy volunteers in an open-label setting and followed a protocol combining metabolomics and mode of action, designed and implemented by Clinic’n’Cell. Professor Gisèle PICKERING, coordinator of the Clinical Investigation Center of the Clermont-Ferrand University Hospital, was Principal Investigator4 .

Metabolomic analysis consists of characterizing the metabolites of an active substance in serum, i.e., the molecules derived from this active substance following their intestinal absorption and passage into the blood. After a single oral dose of 5g of TOTUM•070, which is the clinical daily dose, used also in the HEART clinical study (see below), analysis of the volunteers’ serum confirmed the presence of 22 metabolites of interest, the majority of which are known to have a biological activity on metabolism. Kinetic measurements validated good bioavailability of these metabolites in serum within three hours of oral TOTUM•070 intake.

In a second step, the serum collected from volunteers after oral intake of 5g of TOTUM•070 – a serum rich in active metabolites from TOTUM•070 – was used to conduct in vitro tests on human liver cells exposed to massive lipid intake. In this context of “lipotoxic stress”, the volunteers’ serum exerted two major effects on these human liver cell lines: inhibition of the de novo cholesterol synthesis pathway1 and inhibition of cholesterol storage. It also showed no toxicity.

All analyses were conducted with a double control: cell cultures with and without lipotoxic stress, then with and without serum enriched in active metabolites.

Upcoming publication of the Phase II clinical results of TOTUM•070 on hypercholesterolemia

The Phase II HEART clinical trial results will be announced in the second quarter of 2022. This multi-center study will evaluate the efficacy of TOTUM•070 in reducing blood LDL-cholesterol levels versus placebo, in 120 volunteers with mild to moderate untreated hypercholesterolemia. These results will be decisive for the marketing of TOTUM•070, an innovative 100% plant-based active substance containing neither phytosterols nor red yeast rice, and for its positioning as a reference non-drug option against LDL-cholesterol.

About Valbiotis

Valbiotis is a Research & Development company committed to scientific innovation for preventing and combating metabolic and cardiovascular diseases in response to unmet medical needs.
Valbiotis has adopted an innovative approach, aiming to revolutionize healthcare by developing a new class of health nutrition products designed to reduce the risk of major metabolic diseases, relying on a multi-target strategy enabled by the use of plant-based terrestrial and marine resources.
Its products are intended to be licensed to players in the health sector.
Created at the beginning of 2014 in La Rochelle, the Company has forged numerous partnerships with leading academic centers. The Company has established three sites in France – Périgny, La Rochelle (17) and Riom (63) – and a subsidiary in Quebec City (Canada).
Valbiotis is a member of the "BPI Excellence" network and has been recognized as an "Innovative Company" by the BPI label. Valbiotis has also been awarded "Young Innovative Company" status and 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 about Valbiotis, please visit: www.valbiotis.com

Name: Valbiotis
ISIN Code: FR0013254851
Ticker symbol: ALVAL
EnterNext© PEA-PME 150

This press release contains forward-looking statements about Valbiotis’ objectives. Valbiotis considers that these projections are based on rational hypotheses and the information available to Valbiotis at the present time. However, in no way does this constitute a guarantee of future performance, and these projections may be affected by changes in economic conditions and financial markets, as well as certain risks and uncertainties, including those described in the Valbiotis Universal Registration Document approved by the French Financial Markets Regulator (AMF) on July 27, 2021 (application number R 21-039). This document is available on the Company’s website (www.valbiotis.com ).
This press release and the information it contains do not constitute an offer to sell or subscribe, or a solicitation to purchase or subscribe to Valbiotis’ shares or financial securities in any country.


1 Cholesterol can be brought by food or produced by the body itself ("de novo synthesis").
2 Molecules derived from TOTUM•070, following their intestinal absorption and passage into the blood.
3 The fraction of blood remaining after all blood cells (red blood cells, leukocytes, platelets) and fibrinogen (a protein involved in clotting) have been removed.
4 ID-RCB: 2021-A01211-40

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

ProAmpac Acquires International Paper’s Bag Converting Operations17.10.2025 16:09:00 CEST | Press release

ProAmpac, a global leader in flexible packaging and material science, has acquired the bag converting operations of International Paper (“IP”), a global leader in sustainable packaging. The acquisition expands ProAmpac’s converting capabilities, further advancing the company’s Fiberization of Packaging® strategy and enhancing its ability to deliver customized bag solutions for the grocery, convenience store, and quick-service restaurant markets. “Global demand for reliable, recyclable paper packaging continues to grow rapidly amid evolving consumer expectations and market trends redefining recyclability,” stated Greg Tucker, ProAmpac founder, vice chairman, and chief executive officer. “ProAmpac’s acquisition of IP’s bag operation supports our Fiberization of Packaging initiatives, helping us better serve customers by extending our expertise in material science to the US west coast with additional capabilities and redundancies,” continued Tucker. “IP’s bag business is strong, being bui

Pimicotinib Treatment Demonstrates Deep and Durable Tumor Responses and Continued Improvements in Pain and Function for Patients with TGCT17.10.2025 16:00:00 CEST | Press release

With median follow-up of 14.3 months, pimicotinib demonstrated increasing ORR over time, from 54% at Week 25 to 76.2%Global Phase 3 MANEUVER study demonstrated ongoing improvements in key secondary endpoints including pain and functionApplication for marketing authorization under review by China National Medical Products Administration (NMPA), with additional applications planned in the U.S. and other marketsNot intended for Canada-, UK- or US-based media Merck, a leading science and technology company, today announced the presentation of longer-term results from the global Phase 3 MANEUVER trial evaluating pimicotinib, an investigational colony stimulating factor-1 receptor (CSF-1R) inhibitor in development by Abbisko Therapeutics Co., Ltd., for the treatment of patients with tenosynovial giant cell tumor (TGCT). This latest analysis showed that, with a median follow-up of 14.3 months, the objective response rate (ORR) for people treated with pimicotinib from the beginning of the stud

Vertex Announces Progress in Povetacicept Development Program and Presentation of New Data at American Society of Nephrology Kidney Week17.10.2025 15:04:00 CEST | Press release

- Food and Drug Administration grants rolling review of Biologics License Application for povetacicept in IgA nephropathy; Vertex to submit first module before end of year - - Second pivotal development program of povetacicept underway with Phase 2b/3 trial initiation in primary membranous nephropathy - - Updated data from RUBY-3 trial of povetacicept accepted for late breaking oral presentation; inaxaplin study design and APOL1-mediated kidney disease related data accepted for poster presentation - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced several important updates across its development program for povetacicept (pove), an investigational recombinant fusion protein therapeutic and dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines. Pove has demonstrated best-in-class potential in IgA nephropathy (IgAN) and primary membranous nephropathy (pMN) and has pipeline-in-a-product potential across a range of B c

Qualcomm Announces Quarterly Cash Dividend17.10.2025 15:00:00 CEST | Press release

Qualcomm Incorporated (NASDAQ: QCOM) today announced a quarterly cash dividend of $0.89 per common share, payable on December 18, 2025, to stockholders of record at the close of business on December 4, 2025. About Qualcomm Qualcomm relentlessly innovates to deliver intelligent computing everywhere, helping the world tackle some of its most important challenges. Building on our 40 years of technology leadership in creating era-defining breakthroughs, we deliver a broad portfolio of solutions built with our leading-edge AI, high-performance, low-power computing, and unrivaled connectivity. Our Snapdragon® platforms power extraordinary consumer experiences, and our Qualcomm Dragonwing™ products empower businesses and industries to scale to new heights. Together with our ecosystem partners, we enable next-generation digital transformation to enrich lives, improve businesses, and advance societies. At Qualcomm, we are engineering human progress. Qualcomm Incorporated includes our licensing

Illumynt Reports Q3 2025 Business Update17.10.2025 14:39:00 CEST | Press release

Q3 2025 was a busy quarter once again for us here at illumynt. In addition to naming a new CEO, we executed on a number of initiatives that are propelling our organization forward. Revenue for the quarter exceeded $30 million- keeping us on track for our 2025 plan. More importantly we executed three different large-scale data center decommission projects with almost no material ending up as scrap. All of the AI-focused enterprise equipment and components recovered from the decommissions were resold at top market value. We head into Q4 with high expectations and our eyes wide open. We’re celebrating the 20-year anniversary of our facility in Hong Kong and looking to add another location in the region to help us process inbound AI data center equipment. Stay tuned for updates. There will be more on the way. View source version on businesswire.com: https://www.businesswire.com/news/home/20251017446548/en/

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