Valbiotis - Increased Momentum in the Clinical Newsflow for Major Indications: Results Expected in 2022 for Prediabetes, Hypercholesterolemia and High Blood Pressure
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.
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
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.
Corporate communication / Valbiotis
Carole Rocher / Marc Delaunay
+33 5 46 28 62 58
Financial communication / Actifin
+33 1 56 88 11 14
About Business Wire
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
Everdome Secures US$10 million Investment Commitment from GEM Digital Limited9.8.2022 11:00:00 CEST | Press release
Everdome, the most hyper-realistic metaverse, has announced that GEM Digital Limited (GEM), a Bahamas-based digital asset investment firm that sources, structures and invests in utility tokens listed on over 30 CEXs and DEXs globally, has agreed to an investment commitment of US$10 million into the UAE-based metaverse company through a structured token subscription agreement. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220809005321/en/ Everdome Secures US$10 million Investment Commitment from GEM Digital Limited (Photo: AETOSWire) The announcement comes during a period of heightened activity for Everdome, particularly in terms of its product roll-out and the company’s auction of metaverse land plots. Since June 2022, a total of 11,700 plots (97%) located throughout the Everdome metaverse were sold throughout an eight week auction experience. In total, plots were purchased for upwards of US$18.6 million, which is equivalen
OPEX ® to Exhibit Warehouse Automation Solutions at UK Event for Supply Chain and Logistics Professionals9.8.2022 10:00:00 CEST | Press release
OPEX® Corporation, a global leader in Next Generation Automation for almost 50 years, is introducing leading-edge Warehouse Automation technology to attendees of IMHX, an intralogistics event for professionals involved in the handling, movement or transportation of goods through the supply chain. IMHX 2022 will be held 5-9 September at the NEC Birmingham. This will be OPEX’s first time exhibiting at IMHX and the first time the company’s Sure Sort® robotic sorting system will be on display at a trade show in the UK. “Sure Sort is a scalable and cost-effective alternative to traditional put wall sorting,” said Nicolas Dewit, Director of Business Development for Europe, Middle East, and Asia (EMEA), OPEX Warehouse Automation. “It is an ideal ecommerce solution for micro-fulfillment centers, retail stores, and distribution centers that demand a small footprint, high accuracy, speed, and high productivity in a system that does not increase labor.” Sure Sort robotic delivery vehicles, iBOTs®
Agoda and Alipay+ Expand on Their Partnership to Offer Greater Rewards to Travelers Through Digital Payment Methods9.8.2022 07:39:00 CEST | Press release
Agoda and Alipay+ today announced a new partnership that will leverage Alipay+ solutions on the Agoda platform for better customer benefits and rewards. This is in addition to the existing integration of multiple digital wallets, namely the AlipayHK, GCash and TrueMoney, through Alipay+ on Agoda’s platforms. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220808005877/en/ (Photo: Business Wire) With this new partnership, multiple Alipay+ marketing solutions, including Alipay+ Rewards and its in-cashier marketing services, can be used for discounts distribution and redemption on Agoda. This enables Agoda to enhance its transaction conversion rate, while travelers can enjoy great returns in countries and regions like Hong Kong SAR of China, the Philippines, and Thailand – with the possibility of more regions to come in the future. As the global economy recovers from the COVID-19 pandemic, the online travel industry has seen a v
Abionic Receives IVDR Certification for Its Predictive Ultra-Rapid Sepsis Test Allowing the Management of Antibiotic Administration9.8.2022 06:00:00 CEST | Press release
Abionic SA, a developer of disruptive nanotechnology-based diagnostic solutions, has announced that its Pancreatic Stone Protein (PSP) test on the abioSCOPE® has been certified by BSI certification agency as complying with the European In-vitro Diagnostic Regulation (IVDR), EU 2017/746. This certification granted by notified bodies like BSI is required for in-vitro diagnostics to continue being sold in the European Union. The IVDR’s extensive requirements were adopted by the European Parliament in 2017 and must now be implemented by May 26, 2022. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220808005159/en/ FIVE MINUTES TO SAVE LIVES - Immediate clinical decision-making at your fingertips (Photo: Business Wire) IVDR becomes mandatory as of May 26, 2022. There are also transitional rules that will allow well-established instruments that have not been IVDR certified, but that entered the EU before, to still be sold until 202
A Digital Twin of Kabuki Actor Shido Nakamura Created with NTT’s Another Me Technology Debuts at “Cho Kabuki 2022 Powered by NTT”9.8.2022 05:03:00 CEST | Press release
NTT Corporation (President: Akira Shimada, “NTT”) and Shochiku Co., Ltd. (President & CEO: Junichi Sakamoto) have announced "Cho Kabuki 2022 Powered by NTT" sponsored by Shochiku, with the first act starring Shido Nakamura's digital twin, “Shido Twin.” The debut of Shido Twin showcases NTT’s research and development of a computer that reproduces people as digital twins and is the first step in the social implementation of this new technology. We hope you will come and witness the birth of Shido Nakamura reproduced as a digital twin. Created in collaboration with Shochiku Co., Ltd., the Shido Twin autonomously reproduces the gestures of Shido Nakamura, who plays the leading role in Cho-kabuki, using the body motion generation technology of Another Me. Another Me is a technology born out of NTT’s Digital Twin Computing1 concept. With Another Me, we aim to allow individuals to create an “alternative self” in the digital space, dramatically increasing the opportunities to flourish and grow
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