Valbiotis announces the completion of the enrollment in the Phase II clinical study HEART with TOTUM • 070 in hypercholesterolemia, a risk factor for cardiovascular disease
LA ROCHELLE, France – (BUSINESS WIRE) – Regulatory news:
Valbiotis (FR0013254851 – ALVAL, PEA / SME eligible), a French research and development company dedicated to scientific innovation in the prevention and control of metabolic diseases, announces it is recruiting 120 volunteers for Phase II clinical trials – HEART completed the study earlier this year, September 2021, according to the schedule announced by the company. In line with its development plan, Valbiotis confirms that the results of the HEART study will be available in the second quarter of 2022.
The HEART clinical study is a multicenter, international, randomized, placebo-controlled, double-blind study with 120 people with untreated moderate hypercholesterolemia between 130 and 190 mg / dl. Participants are divided into two equivalent arms of 60 people, who are supplemented with TOTUM • 070 or placebo for 6 months. The primary endpoint of the HEART study is lowering the level of LDL cholesterol in the blood, a risk factor for cardiovascular disease and particularly arteriosclerosis, and has several secondary goals of interest.
Murielle CAZAUBIEL, Head of Development, Medical, Regulatory and Industrial Affairs, member of the Valbiotis Board of Directors, comments: “We are finalizing the registration for the HEART clinical study and are pleased with the progress of this study and look forward to the results in a few months The medical need is real: according to the WHO, almost 40% of the world’s adult population have high cholesterol, a known cardiovascular risk factor, high-risk patients are usually treated with medication. For more moderate forms, however, there is no non-drug, open, clinically proven option to treat excess LDL Reduce cholesterol in the blood before it becomes too high a risk. We are developing TOTUM • 070 to improve this preventive option for as many people as possible. ”
TOTUM • 070 is an innovative active ingredient from food plant extracts, without phytosterols or red mold rice, which was developed to influence the fat metabolism in people with hypercholesterolemia. Once development is complete, TOTUM • 070 will be indicated for people with LDL hypercholesterolemia at levels up to 190 mg / dL with a moderate overall cardiovascular risk. TOTUM • 070 could be recommended in this large population for which no first-line drug treatment is currently recommended (see press release of October 27, 2020).
Sébastien BESSY, Head of Marketing and Commercial Operations, member of the Valbiotis Board of Directors, explains: “The HEART clinical trial is a key element of the marketing strategy: it aims to demonstrate the effectiveness of our active ingredient TOTUM • 070 for people at risk who are currently not receiving treatment. The market for untreated hypercholesterolemia is already very significant, valued at € 1.2 billion in Europe and the United States.2 In these huge markets, the success of HEART TOTUM • 070 would provide a significant advantage with consumers. ”
Untreated Hypercholesterolemia: The Big Market for Non-Drug Products
In the top 5 European countries (France, Germany, Italy, Spain, United Kingdom) and the United States, an estimated 174 million adults have elevated LDL cholesterol levels2,3. Thanks to a high diagnosis rate of almost 50%, the diagnosed population is 83 million people2.
According to the recommendations, however, only people with a high overall cardiovascular risk are treated. A large proportion of diagnosed people are therefore already turning to non-drug products, especially in the USA (54% of diagnosed people), Great Britain (58%), France (34%) and Germany (35%) 2. The market for these LDL cholesterol-lowering drugs in these regions is now estimated at nearly 1.2 billion euros, of which more than 600 million euros are in the United States2.
Valbiotis is a research and development company committed to scientific innovation to prevent and control metabolic diseases in response to unmet medical needs.
Valbiotis is taking an innovative approach with the aim of revolutionizing healthcare by developing a new class of health nutritional products designed to reduce the risk of serious metabolic diseases based on a multi-target approach made possible through the use of herbal ingredients.
Its products are to be licensed to players in the health sector.
Founded in La Rochelle in early 2014, the company has entered into numerous partnerships with leading academic centers. The company has three locations 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 by the BPI label as an “Innovative Company”. Valbiotis has also been awarded the status of “Young Innovative Company” and has received substantial financial support from the European Union for its research programs through the European Regional Development Fund (ERDF). Valbiotis is a PEA SME Eligible Company.
More information about Valbiotis can be found at: www.valbiotis.com.
ISIN code: FR0013254851
Ticker symbol: ALVAL
EnterNext © PEA-PME 150
This press release contains forward-looking statements about Valbiotis’ goals. Valbiotis believes that these projections are based on rational hypotheses and the information currently available to Valbiotis. However, this is in no way 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 government are the Financial Market Authority (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 contained therein do not constitute an offer to sell or a subscription, or an invitation to buy or subscribe for Valbiotis shares or financial instruments in any country.
12018 Guideline on the Management of Blood Cholesterol, a report from the American College of Cardiology / American Heart Association, Journal Of The American College Of Cardiology, 2019.
2AEC partner data, 2019, for Valbiotis.
3LDL blood cholesterol levels greater than 100 or 130 mg / dL, depending on available data.