Valbiotis – Acceleration of clinical news for major indications: results expected in 2022 for prediabetes, hypercholesterolemia and arterial hypertension
LA ROCHELLE, France – (COMMERCIAL THREAD) – Regulatory news:
Valbiotis (Paris: ALVAL) (FR0013254851 – ALVAL, PEA / PME eligible), a Research and Development company committed to scientific innovation to prevent and fight against metabolic and cardiovascular diseases, is updating its calendar, which will accelerate in 2022 with many study results expected during the year concerning the prevention of metabolic and cardiovascular diseases. The clinical results for three active substances in the portfolio will be available and will be decisive for the launch of these substances on the prediabetes, hypercholesterolemia and arterial hypertension markets. The Company is now fully able to finance this market plan.
SÃ©bastien PELTIER, CEO of Valbiotis, declared: âAfter a year of in-depth work in 2021, dedicated in particular to advancing the clinical plans of our three initial active ingredients, 2022 should bring significant clinical results in three key indications: prediabetes, hypercholesterolemia and arterial hypertension. These clinical results are crucial: they must demonstrate that our innovative active ingredients are effective for patients and meet the objective of preventing metabolic and cardiovascular diseases at an early stage. These results should also enable us to quickly reach a new stage in our development: transforming our scientific expertise into a marketable reality. I hope that by achieving these objectives, we will meet the expectations of all our stakeholders – patients, healthcare professionals, partners and investors – and consolidate Valbiotis’ positioning as a leader in disease prevention, in line with the public health policies.
The calendar of clinical study results announced for 2022 is in line with the development plans adopted for the active ingredients of Valbiotis. These plans have been designed to support a very differentiating marketing positioning in the prevention market, based on clinical evidence and proprietary health claims, with the objective of rapid time to market.
Murielle CAZAUBIEL, Member of the Board of Directors and Director of Medical, Regulatory and Industrial Affairs of Valbiotis, declared: âDecisive clinical advances should be made in 2022 on three active ingredients in our portfolio, the first strong point being in the area of ââhypercholesterolemia with TOTUM â¢ 070. The first data on the clinical bioavailability and mode of action of TOTUM â¢ 854, which targets the management of arterial hypertension – again the need is great – will follow, before the highly anticipated results of TOTUM â¢ 63 at the end of the year. year.
I am convinced 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 enter the market for the prevention of metabolic and cardiovascular diseases.
Details on the expected clinical results in 2022 are as follows:
Decisive clinical results for TOTUM â¢ 63 to fight prediabetes in 4e quarter 2022
The results of the pivotal Phase II / III REVERSE-IT study on TOTUM â¢ 63 should be available by the end of 20222. This large international multicenter study, carried out 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) at Laval University in Quebec. This study will include 20 volunteers and will explore many mechanistic parameters of the pathophysiology of prediabetes and type 2 diabetes (press release of June 28, 2021).
The TOTUM â¢ 63 studies are being carried out within the framework of a global strategic partnership with NestlÃ© Health Science and will be the subject of milestone payments, dedicated in particular to their financing.
Results of efficacy and mode of action of TOTUM â¢ 070 in the fight against hypercholesterolemia in 2sd quarter 2022
The results of the Phase II HEART study will be announced in the second quarter of 2022. This multicenter study should demonstrate the effectiveness of TOTUM â¢ 070 in reducing LDL-cholesterol levels compared to placebo in 120 volunteers with mild hypercholesterolemia. to moderate untreated. These results will be decisive for the marketing of TOTUM â¢ 070, an innovative 100% plant-based active ingredient, without phytosterol or red rice yeast, and for its positioning as a benchmark non-drug option to fight LDL cholesterol. .
At the same time, an open study on the bioavailability and mode of action of TOTUM â¢ 070, carried out 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 investigations on human cell lines.
Results of bioavailability and mode of action of TOTUM â¢ 854 in the management of arterial hypertension in 4e quarter 2022
The results of the open study on the bioavailability and mode of action of TOTUM â¢ 854, carried out on 10 volunteers, will be available in the fourth quarter of 2022. Like the TOTUM â¢ 070 study, this study combines a clinical evaluation, a study bioavailability, identification of metabolites and in vitro mechanistic explorations on human cell lines involved in the regulation of arterial pressure.
TOTUM â¢ 854 is an active substance based on five plant extracts, designed to reduce blood pressure. Its clinical development includes two Phase II / III studies, the protocols of which were filed in December 2021 (press release of December 1, 2021). They must demonstrate the efficacy of TOTUM â¢ 854 in reducing systolic blood pressure, compared with a placebo, in a population of volunteers with untreated mild to moderately elevated blood pressure.
In addition to these three active ingredients in the clinical phase, the results of which will be available in 2022, Valbiotis is working on the development of TOTUM â¢ 448, an active ingredient to fight against metabolic liver diseases (NAFL and NASH).
TOTUM â¢ 448: an updated plan to fight metabolic liver disease (NAFL and NASH)
TOTUM â¢ 448, the fourth active substance in the Valbiotis portfolio, is being developed to meet unmet needs in the treatment of metabolic liver diseases: non-alcoholic hepatic steatosis and non-alcoholic steatohepatitis (NAFL and NASH). The development plan has been updated to better respond to the challenges of these emerging pathologies for which effective preventive and therapeutic strategies remain to be identified. This plan will be based on an innovative design study, carried out in âreal lifeâ in health centers, directly involving the care of patients. Combined with clinical studies on the mode of action, this work, carried out as close as possible to the field, will allow TOTUM â¢ 448 to be optimally positioned for the management of NAFL and NASH. Details of this development plan will be announced at a later date.
Valbiotis is a Research & Development company committed to scientific innovation to prevent and fight metabolic diseases in response to unmet medical needs.
Valbiotis has adopted an innovative approach aimed at revolutionizing health by developing a new class of health nutrition products intended to reduce the risk of major metabolic diseases, based on a multi-target strategy made possible by the use of plant resources. land and sea.
Its products are intended to be licensed to players in the health sector.
Founded in early 2014 in La Rochelle, the Company has established numerous partnerships with leading academic centers. The Company has established three sites in France – PÃ©rigny, La Rochelle (17) and Riom (63) – and a subsidiary in Quebec (Canada).
Valbiotis is a member of the âBPI Excellenceâ network and has been recognized as an âInnovative Companyâ by the BPI label. Valbiotis has also obtained the status of âYoung Innovative Companyâ and has received significant financial support from the European Union for its research programs via the European Regional Development Fund (ERDF). Valbiotis is a company eligible for PEA-PME.
For more information on Valbiotis, visit: www.valbiotis.com
ISIN code: FR0013254851
Ticker symbol: ALVAL
EnterNext Â© PEA-PME 150
This press release contains forward-looking statements about the objectives of Valbiotis. Valbiotis considers that these projections are based on rational assumptions and the information available to Valbiotis to date. However, this in no way constitutes a guarantee of future performance, and these projections may be affected by changes in economic conditions and financial markets, as well as by certain risks and uncertainties, including those described in the Universal Registration Document. de Valbiotis approved by the AutoritÃ© des MarchÃ©s Financiers (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, nor a solicitation to buy or subscribe to Valbiotis shares or financial securities in any country whatsoever.
1Institute of Nutrition and Functional Foods (INAF)
2Originally scheduled for mid-2022