LA ROCHELLE, France--(BUSINESS WIRE)--Regulatory News:
VALBIOTIS (Paris:ALVAL) (FR0013254851 – ALVAL / PEA/SME eligible), a Research & Development company committed to scientific innovation for preventing and combating metabolic diseases, announces today, that as part of its global partnership with Nestlé Health Science, it is launching the pivotal late stage development phase of TOTUM-63, a plant-derived active substance with clinically demonstrated metabolic health benefits on people with prediabetes.
This last phase of the clinical development was co-designed with Nestlé Health Science's medical and regulatory teams and consists of one pivotal Phase II/III clinical study, called REVERSE-IT. This clinical trial will include people with prediabetes and with early stage untreated Type 2 Diabetes. It will pursue two main strategic objectives:
- Replicate the previous Phase II positive result on fasting blood sugar levels, a well-established risk factor for developing Type 2 Diabetes;
- Extend the evaluation of TOTUM-63 to patients with early stage untreated Type 2 Diabetes, to enlarge the final target population.
The launch of the REVERSE-IT trial is planned for the first half of 2020. In order to rapidly complete the recruitment, the trial will be led in more than 30 international clinical centers. It will be entirely funded by the partnership signed in February 2020 with Nestlé Health Science.
Murielle CAZAUBIEL, Head of Development and Medical Affairs, states: “The REVERSE-IT study results from the combined expertise of VALBIOTIS and Nestlé Health Science. We have strong ambitions for this last regulatory clinical phase, that are based on the very good results we obtained in the previous Phase II clinical trial. Considering the resources we mobilize, we can reasonably expect the topline data to be released before mid-2022. We feel enthusiastic for this final step of our innovative R&D process and we are confident in the fact that it will get TOTUM-63 to wide and successful commercialization, which may take place before obtaining health claims.”
Hans-Juergen WOERLE, Chief Scientific & Medical Officer of Nestlé Health Science, adds: “The scope and conditions of this clinical trial are significant: it is being led in 30 international clinical settings with 600 participants. The thoroughness of this trial will provide results that are extremely useful in demonstrating a safe and effective opportunity to help patients who have prediabetes and Type 2 Diabetes."
The REVERSE-IT trial will be randomized and placebo-controlled, with the same primary objective (reduction in fasting glycemia), the same duration of supplementation (6 months) and the same tested dose (5g/day) and regimen (three times per day) than the previous Phase II study, which positive results were published in 2019 (Press releases, 3rd July 2019 and 2nd September 2019).
The study population will include 600 subjects with abnormally elevated fasting blood glucose (dysglycemia) and abdominal obesity, two frequently associated conditions. The number of subjects included will guarantee the robustness of this pivotal trial.
Led in a wider population, this trial will also pursue larger clinical objectives, with a three-arm design. The regimen of three doses per day, for a total daily dose of 5g, will be tested against placebo (200 subjects receiving TOTUM-63 in one arm and 200 subjects receiving a placebo in the second arm). The primary criterion is the reduction in fasting blood glucose against placebo, with this three doses per day regimen. A third open label arm will test a regimen of two doses per day, for the same total daily dose of 5g, on 200 subjects.
The trial will evaluate several other metabolic criteria of high interest for people with prediabetes or early stage untreated Type 2 Diabetes.
The partnership with Nestlé Health Science also plans an adjunct clinical study to obtain exploratory data on TOTUM-63 mode of action in humans.
VALBIOTIS will provide details on its other products in a subsequent communication.
TOTUM-63 is a unique and patented combination of 5 plant extracts, with high potential to target the physiopathological mechanisms of Type 2 Diabetes.
TOTUM-63 has already been proven safe and effective in healthy human volunteers during a Phase I/II clinical study. The results of the international randomized, placebo-controlled Phase II study showed that TOTUM-63 reduced fasting and 2-hour blood sugar levels, two risk factors for Type 2 Diabetes, in prediabetics compared to placebo. In these subjects, who also had abdominal obesity, TOTUM-63 significantly reduced body weight and waist circumference.
TOTUM-63 benefits from intellectual property granted in the main markets worldwide: Europe (covering 39 countries), the United States, Russia and national phases are underway in more than 20 countries including China, Japan, Brazil, Australia. The ability to produce TOTUM-63 industrially, in compliance to North American and European standards, has been validated. TOTUM-63 already has marketing authorizations related to its status in Europe.
In 2020, VALBIOTIS has signed a global and long-term partnership with Nestlé Health Science for the development and worldwide commercialization of TOTUM-63. This unique partnership in the field of Nutrition Health plans that TOTUM-63 will be put on the market by Nestlé Health Science at a global level, possibly before obtaining a health claim, depending on the areas. It will also provide funding for the latest clinical development stages of TOTUM-63.
ABOUT NESTLE HEALTH SCIENCE
Nestlé Health Science (NHSc), a wholly-owned subsidiary of Nestlé, is a globally recognized leader in the field of nutritional science. At NHSc we are committed to empowering healthier lives through nutrition for consumers, patients and their healthcare partners. We offer an extensive consumer health portfolio of industry-leading medical nutrition, consumer and VMS brands that are science-based solutions covering all facets of health from prevention, to maintenance, all the way through to treatment. Headquartered in Switzerland, NHSc employs over 5’000 people around the world, who are committed to making a difference in people’s lives, for a healthier today and tomorrow.
For more information, please visit: www.nestlehealthscience.com.
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 nutritional health solutions designed to reduce the risk of major metabolic diseases, based on a multi-target approach and made possible by the use of plant-based ingredients.
Its products are intended to be licensed to players in the health world.
VALBIOTIS was founded in La Rochelle in early 2014 and has formed numerous partnerships with top academic centers. The Company has established three sites in France – Périgny, La Rochelle (17) and Riom (63).
VALBIOTIS is a member of the "BPI Excellence" network and received the "Innovative Company" status accorded by BPI France. Valbiotis has also been awarded "Young Innovative Company" status and has received major financial support from the European Union for its research programs by obtaining support from the European Regional Development Fund (ERDF). VALBIOTIS is a PEA-SME eligible company.
Find out more about VALBIOTIS: www.valbiotis.com
ISIN code: FR0013254851
Mnemonic code: ALVAL
This press release contains forward-looking statements about VALBIOTIS' objectives, based on rational hypotheses and the information available to the company at the present time. However, in no way does this constitute a guarantee of future performance, and these projections can be reconsidered based on changes in economic conditions and financial markets, as well as a certain number of risks and doubts, including those described in the VALBIOTIS core document, filed with the French Financial Markets Regulator (AMF) on 31 July 2019 (application number R19-030) as well in its supplement approved by the AMF on Octobre 9, 2019. These documents being available on the Company’s website (www.valbiotis.com). This press release, as well as the information contained herein, does not constitute an offer to sell or subscribe to, or a solicitation to purchase or subscribe to, VALBIOTIS' shares or securities in any country.