Business Wire

Valbiotis - Increased Momentum in the Clinical Newsflow for Major Indications: Results Expected in 2022 for Prediabetes, Hypercholesterolemia and High Blood Pressure

Share

Regulatory News:

Valbiotis (Paris:ALVAL) (FR0013254851 – ALVAL, PEA/SME eligible), a Research and Development company committed to scientific innovation for preventing and combating metabolic and cardiovascular diseases, updates its calendar, which will gain momentum in 2022 with a number of clinical study results expected during the year concerning the prevention of metabolic and cardiovascular diseases. Clinical results regarding three active substances in the portfolio will become available and will be key for the launch of these substances on the prediabetes, hypercholesterolemia and high blood pressure markets. The Company is fully able to finance this market plan today.

Sébastien PELTIER, CEO of Valbiotis, commented: “After a year of substantive work in 2021, dedicated in particular to moving the clinical plans for our three initial active substances forward, 2022 should provide significant clinical results for three key indications: prediabetes, hypercholesterolemia and high blood pressure. These clinical results are critical: they must demonstrate that our innovative active substances are effective for patients and meet the goal of preventing metabolic and cardiovascular diseases in their earliest stages. These results must also allow us to rapidly reach a new milestone in our development: converting our scientific expertise into a marketable reality. I hope that, by reaching these objectives, we will meet the expectations of all our stakeholders - patients, healthcare professionals, partners and investors - and confirm Valbiotis’ positioning as a leader in disease prevention, in line with public healthcare policies.”

The clinical study results calendar announced for 2022 complies with the development plans adopted for Valbiotis’ active substances. These plans were designed to support a highly differentiating marketing positioning on the prevention market, based on clinical evidence and proprietary health claims, with the goal being a rapid market launch.

Murielle CAZAUBIEL, Member of the Board of Directors and Director of Medical, Regulatory and Industrial Affairs at Valbiotis, stated: “Decisive clinical advances should be achieved in 2022 on three active substances in our portfolio, the first major high point being in the field of hypercholesterolemia with TOTUM•070. This will be followed by initial clinical bioavailability and mode of action data for TOTUM•854, which targets management of arterial hypertension - here again, the need is great - before the highly anticipated TOTUM•63 results at the end of the year.
I strongly believe that our efforts will be rewarded with solid clinical results, which are both the DNA of our R&D and at the heart of our strategy to access the prevention market for metabolic and cardiovascular diseases.”

Details on the clinical results expected in 2022 are as follows:

Decisive clinical results for TOTUM•63 to combat prediabetes in 4th quarter of 2022
The results of the pivotal Phase II/III REVERSE-IT study on TOTUM•63 should be available by the end of 20222. This major international multicenter study, conducted on 600 hyperglycemic volunteers, should confirm the Phase II results obtained in 2019 in a similar population.
In addition, an exploratory study on the mode of action will be conducted by the Institute of Nutrition and Functional Foods (INAF) of Laval University in Quebec. This study will include 20 volunteers and will explore numerous mechanistic parameters of the pathophysiology of prediabetes and type 2 diabetes (press release of June 28, 2021).
The TOTUM•63 studies are conducted as part of a global strategic partnership with Nestlé Health Science and will be the subject of milestone payments, dedicated in particular to their financing.

Efficacy and mode of action results for TOTUM•070 in combating hypercholesterolemia in 2nd quarter of 2022
The results of the Phase II HEART study will be announced in the second quarter of 2022. This multicenter study should demonstrate the efficacy of TOTUM•070 in reducing LDL-cholesterol levels compared to a placebo in 120 volunteers presenting untreated mild to moderate hypercholesterolemia. These results will be decisive for the market launch of TOTUM•070, an innovative active substance that is 100% plant-based, with no phytosterol or red yeast rice content, and for its positioning as a leading non-drug option to combat LDL-cholesterol.
At the same time, an open-label study on the bioavailability and mode of action of TOTUM•070, conducted on 10 volunteers, will also provide results in the second quarter of 2022. It combines a clinical evaluation, a bioavailability study, the identification of metabolites, and in vitro mechanistic explorations on human cell lines.
Bioavailability and mode of action results for TOTUM•854 in the management of arterial hypertension in 4th quarter of 2022
The results of the open-label study on the bioavailability and mode of action of TOTUM•854, conducted on 10 volunteers, will be available in the fourth quarter of 2022. Like the TOTUM•070 study, this study combines a clinical evaluation, a bioavailability study, the identification of metabolites and in vitro mechanistic explorations on human cell lines involved in regulating blood pressure.
TOTUM•854 is an active substance based on five plant extracts, designed to reduce blood pressure. Its clinical development includes two Phase II/III studies, whose protocols were submitted in December 2021 (press release of December 1, 2021). They should demonstrate the efficacy of TOTUM•854 in reducing systolic blood pressure, compared to a placebo, in a population of volunteers presenting untreated mild to moderately high blood pressure.
In addition to these three active substances in their clinical phase, whose results will be available in 2022, Valbiotis is working on the development of TOTUM•448, an active substance to combat metabolic liver diseases (NAFL and NASH).

TOTUM•448: an updated plan to combat metabolic liver diseases (NAFL and NASH)
TOTUM•448, the fourth active substance in Valbiotis’ portfolio, is being developed to address unmet needs in the treatment of metabolic liver diseases: non-alcoholic fatty liver disease and non-alcoholic steatohepatitis (NAFL and NASH). The development plan has been updated to better meet the challenges of these emerging pathologies for which effective preventive and therapeutic strategies have yet to be identified. This plan will be based on an innovatively designed study, conducted in “real life” in healthcare centers, directly involving patient management. Combined with clinical studies on mode of action, this work, conducted very close to the field, will allow for TOTUM•448 to be optimally positioned for the management of NAFL and NASH. Details on this development plan will be announced at a future time.

About Valbiotis
Valbiotis is a Research & Development company committed to scientific innovation for preventing and combating metabolic 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.

1Institute of Nutrition and Functional Foods (INAF)
2Initially planned for mid-2022

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Corporate communication / Valbiotis
Carole Rocher / Marc Delaunay
+33 5 46 28 62 58
media@valbiotis.com

Financial communication / Actifin
Stéphane Ruiz
+33 1 56 88 11 14
sruiz@actifin.fr

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

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

Enedym Inc. Announces Strategic Partnership With JFE Shoji25.1.2022 14:00:00 CET | Press release

Enedym Inc. (“Enedym”), the technology company thatdevelops next generation switched reluctance motors (SRMs), electric propulsion, and electrified powertrains, announced today that it has formed a strategic partnership with JFE Shoji Power Canada Inc., (“JFE Shoji Canada”), one of the largest providers of transformer cores, magnetic materials for electrical engineering applications, and electrical engineering support and design services in North America. Under the terms of the partnership, JFE Shoji Canada, will be a key supplier of electrical steel for Enedym’s electric motors and powertrains. JFE Shoji Canada is part of the JFE Shoji Corporation (“JFE Shoji Corp”), a global supplier of electrical steel materials and products to the global auto industry and leading electric vehicle automakers like Rivian Automotive, Inc. through its world-wide motor core manufacturing and supply business in Mexico, India, China, Japan and Asia, with supportive ownership from JFE Holdings of Japan. Dr

B2Broker Group Acquires Mauritius FSC Licence to Provide Multi-Asset Brokerage Services25.1.2022 13:00:00 CET | Press release

B2Broker, a leading liquidity and technology provider of solutions to the Forex and financial services industry, has secured a licence from the Financial Services Commission (FSC) Mauritius, the company has announced. The licence has been acquired under the name of B2B Prime Services Limited, a member of the B2Broker Group of Companies, which as of 12th November, 2021, possesses an Investment Dealer licence (Full Service Dealer excluding underwriting /code SEC-2.1, Licence # C117017139). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220125005241/en/ Under Mauritius regulation, the company will operate as a Prime of Prime (PoP) Multi-Asset Liquidity Provider, focusing on institutional and professional clients across the whole spectrum of the financial markets. Its core investment services consist of leveraged derivative products in CFDs (e.g. Forex, metals, commodities, shares, indices). (Graphic: Business Wire) Description

BitMEX Welcomes New Head of Trading Bill Beller25.1.2022 12:03:00 CET | Press release

Crypto investment platform BitMEX is delighted to welcome Bill Beller as Head of Trading, effective 1 January. Bill is in charge of spearheading the company’s trading strategies and expanding the BitMEX trading team and its capabilities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220125005650/en/ BitMEX Welcomes New Head of Trading Bill Beller (Photo: Business Wire) Prior to joining BitMEX, Bill was Managing Director at Greenville Advisory for nearly five years, where he helped FinTech start-ups launch crypto exchange platforms and meet evolving regulatory requirements. Prior to that, he was Managing Director - Head of Equities for Sberbank CIB and Managing Director, Head of EEMEA Equity Derivatives Flow Trading at UniCredit. He brings over a decade of experience in risk management, building trading infrastructure, and managing equities and derivatives investments across global capital markets. Bill said: “BitMEX is fast

Lithion Recycling Enters a Partnership with IS Dongseo Company for an Exclusive License of its Lithium-ion Battery Recycling Technology in South Korea25.1.2022 12:00:00 CET | Press release

Lithion Recycling, Inc. (“Lithion”) is proud to announce it has reached an agreement with IS Dongseo Company Ltd (“ISD”), a Korea-based leading ESG company with an environmental business segment, for an exclusive business right for the use of its lithium-ion battery recycling technology on the Korean market. This partnership is the first of a series that Lithion aims to conclude in upcoming years for the use of its cutting-edge, eco-friendly technology on world markets. It will allow ISD to offer an environmentally friendly and cost-effective recycling solution to close the loop on battery materials in Korea. IS Dongseo plans to start building its first Korean facility capable of processing about 7,500 tons of waste batteries per year (or the equivalent of approximately 20,000 electric car batteries), this year. This first phase will be followed by a second one, with the construction of a hydrometallurgy plant based on Lithion’s technology, allowing ISD to supply over 15,000 tons of ba

Square Announces Official Launch in Spain After Successful Early Access Programme25.1.2022 11:30:00 CET | Press release

Square, the company specialising in software, payments, and hardware solutions for businesses of all sizes, announces its arrival in Spain following a successful Early Access Programme. Starting today, Spanish entrepreneurs, freelancers and business owners will be able to use Square's ecosystem of tools; the only end-to-end solution of its kind in the country. "We’ve been trialing Square’s suite of products both in-store and online and we love it,” said Miguel Gil, owner of Hop Hop Hurrah, one of the first businesses to use Square’s products in Spain. “Having a point-of-sale system with integrated payments and omnichannel solutions has transformed the way we’re able to run our business, making it an easy and seamless process. We’re pleased we were able to switch to Square and feel much more confident in our ability to grow, ensuring we never miss a sale, as we look towards the future.” Square is part of Block, Inc. a global technology company focused on financial services, founded in 2

J.P. Morgan to Acquire a Stake in Viva Wallet25.1.2022 11:00:00 CET | Press release

J.P. Morgan (NYSE: JPM) announced today that it has entered into an agreement with Viva Wallet Holdings Software Development S.A. (Viva Wallet), a leading European cloud-based payments fintech company, and its existing shareholders to acquire an ownership stake of approximately 49 percent, subject to regulatory approvals. Financial terms of the transaction were not disclosed. “We are very excited to make a strategic investment in Viva Wallet to support their vision to empower new growth and payments innovation targeted at European small and midsize businesses (SMBs) and middle market merchant services clients,” said Takis Georgakopoulos, Global Head of J.P. Morgan Payments. “The European payments landscape is fragmented yet large in terms of opportunity, with more than 17 million merchants1 ready to implement scalable payments solutions and this is a big focus area for added growth for J.P. Morgan Payments in the future.” Founded in 2000, Viva Wallet is headquartered in Athens, Greece,

The O-RAN ALLIANCE Announces the 5 th Release of Its Open Source Software and An Industry Briefing at MWC Barcelona25.1.2022 10:49:00 CET | Press release

O-RAN ALLIANCE: O-RAN ALLIANCE Industry Briefing, March 1, 2022 at MWC Barcelona O-RAN ALLIANCE plans to hold its next industry event on March 1, 2022 from 17:15-18:00 CET, hosted at the Deutsche Telekom booth at MWC Barcelona 2022, Hall 3 Stand 3M31. The event will include keynotes from O-RAN ALLIANCE’s leadership and an industry panel discussion. Save the date and follow our website for further updates. 5th Release of Open Software for the RAN – “E” – Delivered by the O-RAN Software Community The O-RAN Software Community (OSC or O-RAN SC) was formed in partnership with the Linux Foundation in April 2019, to support software development of open RAN solutions available to everyone. In December 2021, following on the half year release cycle, the OSC published its 5th open software release dubbed "E". The E release further enhances the traffic steering use case, introduces basic RAN slicing feature and closed loop slice SLA assurance. With these enhanced features and the end-to-end integ