
VALBIOTIS: Authorization to Launch the International Phase II/III REVERSE-IT Clinical Study on TOTUM-63, to Reduce Type 2 Diabetes Risk Factors
Regulatory News:
VALBIOTIS (FR0013254851 - ALVAL / PEA/SME eligible), a Research & Development company committed to scientific innovation, for preventing and combating metabolic diseases, announces the favourable opinion issued from the French Ethical Committee (CPP) and the authorization received from the French National Agency for the Safety of Medicines and Health Products (ANSM) to launch the international Phase II/III REVERSE-IT clinical study on TOTUM-63, to reduce Type 2 Diabetes risk factors.
This clinical study primarily aims at confirming the Phase II positive results previously obtained on the reduction of fasting glycemia, a risk factor for developing Type 2 Diabetes, to obtain health claims from American and European authorities. This study is the latest phase of the development of TOTUM-63. TOTUM-63 is an innovative active substance derived from plants, which has already shown metabolic benefits in people with prediabetes.The CPP favourable opinion and the ANSM authorization allow to initiate the enrollments of 600 subjects with prediabetes and untreated Type 2 Diabetes (early stage) in the study.
Pr Samy HADJADJ, Diabetologist and Professor of Endocrinology and Diabetology at Nantes University Hospital, scientific expert of the study, comments: “From a prevention perspective, it is essential to act on early stages of metabolic imbalance, before the onset of Type 2 Diabetes or early at disease onset. This is the purpose of the REVERSE-IT study, designed and sized to establish the efficacy of this approach. To do so, we will assess the impact of TOTUM-63 on the main metabolic risk factors for developing Type 2 Diabetes, with particular attention to glycemic parameters, abdominal obesity and body weight”.
Murielle CAZAUBIEL, Member of the Management Board, Director of Development and Medical Affairs at VALBIOTIS, adds: "We are satisfied to receive the CPP favourable opinion and the ANSM authorization to start the REVERSE-IT clinical study, which will complete the development of our active substance TOTUM-63. It is a major clinical study, through its objective and methodology, to validate our approach in the fight against Type 2 Diabetes. With our teams and all our partners at our side, we are now eager to carry it out, to offer all people with prediabetes the opportunity to benefit from it."
The REVERSE-IT study follows the positive results of the Phase II study on TOTUM-63, for the reduction of Type 2 Diabetes risk factors. These results were published in 2019 (Press releases of July 3 and September 2, 2019) and presented during the American Diabetes Association scientific sessions in June 2020. The REVERSE-IT study will take up the same primary endpoint (reduction of fasting blood glucose level), the same tested dose (5g / day) and the same regimen (three times a day during 6 months). It was co-designed with the medical and regulatory teams of Nestlé Health Science, as part of the global strategic partnership signed in February 2020 for the development and marketing of TOTUM-63.
ABOUT TOTUM-63
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 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.
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 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
Name: Valbiotis
ISIN code: FR0013254851
Mnemonic code: ALVAL
DISCLAIMER
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200707005886/en/
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
MEDIA RELATIONS / MADIS PHILEO
Guillaume DE CHAMISSO
+33 6 85 91 32 56
guillaume.dechamisso@madisphileo.com
About Business Wire
(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
H.I.G. Capital Announces the Sale of DGS S.p.A.11.6.2024 12:00:00 CEST | Press release
H.I.G. Capital (“H.I.G.”), a leading global alternative investment firm with $62 billion of capital under management, is pleased to announce that an affiliate has signed a definitive agreement to sell its portfolio company, DGS S.p.A. (“DGS” or the “Group”), a leading firm in the Italian Information Technology market, to DGS Co-Founders and management team in partnership with ICG, a global alternative asset manager. Since its inception in 1997, DGShas supported blue-chip customers in the design, integration, and maintenance of complex IT systems, with a specialization in digital transformation and cybersecurity services. The Group currently has over 1,900 employees, revenues of approximately €300 million, and maintains a group of highly loyal clientele. During H.I.G.’s ownership, DGS has tripled in size and consolidated its position as a leading Italian firm in cybersecurity services and digital transformation. DGS offers its clients sophisticated and proprietary digital transformation
Evertas Names Nick Selby Head of European Underwriting11.6.2024 12:00:00 CEST | Press release
Evertas, the world’s first crypto insurance company, has named Nick Selby as its new Head of European Underwriting. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240611141887/en/ Nick Selby, Executive Vice President and Head of European Underwriting at Evertas (Photo: Business Wire) Selby, an accomplished information and physical security professional, brings two decades of expertise in public and private sector information security, physical security, and complex incident handling, as well as seven years of experience leading teams securing billions of dollars in cryptoassets. Previously, his roles included VP of the Software Assurance Practice at Trail of Bits, Chief Security Officer at Paxos Trust Company, and Director of Cyber Intelligence and Investigations at the NYPD Intelligence Bureau. “Nick is an extremely valuable addition to our European team,” said Evertas CEO and Co-Founder J. Gdanski. “His public and private
Owlet utvider globalt fotavtrykk med lanseringen av medisinsk-sertifisert Dream Sock™ i Storbritannia og over hele Europa11.6.2024 11:00:00 CEST | Pressemelding
Owlet, Inc. («Owlet» or the «Company») (NYSE:OWLT), pioneren innen smart spedbarnsovervåking, kunngjør i dag den britiske og europeiske lanseringen av Dream Sock. Dette er en smart babymonitor med levende helseavlesninger og varsler for friske spedbarn mellom 0-18 måneder og 2,5-13,6 kg. Dette innovative medisinske utstyret gir foreldre helse og viktig informasjon i sanntid, noe som gir uovertruffen trygghet. Denne pressemeldingen inneholder multimedia. Se hele pressemeldingen her: https://www.businesswire.com/news/home/20240611820341/no/ (Photo: Business Wire) «Vi er svært stolte over å lansere Dream Sock til omsorgspersoner over hele Storbritannia og Europa og gi millioner av foreldre mer trygghet mens babyen sover,» sa Kurt Workman, Owlets administrerende direktør og medgründer. «Dream Sock er nå et globalt produkt som er anerkjent som medisinsk nøyaktig og trygt, etter å ha gjennomgått regulatoriske autorisasjoner og sertifiseringer innenfor flere geografier. I dag er misjonen vår
V-Nova Surpasses 1000 Patent Milestone in Media Technology Innovation11.6.2024 10:00:00 CEST | Press release
V-Nova, a leading provider of data compression solutions, video compression technology, XR technology, AI acceleration and parallel processing for a multitude of industries including media and entertainment, today announced its milestone achievement of 1000 active technology patents. This accomplishment underscores V-Nova’s dedication to research and development and its commitment to protecting its intellectual property globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240611724561/en/ V-Nova’s patent portfolio spans more than 50 different jurisdictions. Including over 400 patents in Europe, over 200 in the Americas, over 100 in the United States specifically, and over 200 in Asia. V-Nova forged new directions in data processing to enhance digital experiences, maximize efficiency, reduce costs, and increase sustainability. The company leads the way with key international data compression standards for the video indust
Alipay+ Reveals Top Scorer Trophy Design for UEFA EURO 2024™11.6.2024 09:24:00 CEST | Press release
Alipay+, a suite of cross-border mobile payment and digitalization technology solutions operated by Ant International and an Official Partner of UEFA EURO 2024™, today revealed the trophy that will be awarded to the most prolific marksman at the UEFA EURO 2024™ finale on July 14 in Berlin, Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240610328619/en/ The UEFA Top Scorer Trophy presented by Alipay+ is unveiled for UEFA EURO 2024™ (Photo: Business Wire) Sculpted in the shape of the Chinese character “支” (pronounced zhi, and meaning payment as well as support), the trophy reflects Alipay+’s dedication to supporting consumers to enjoy seamless payment and a broad choice of deals using their preferred payment methods while traveling abroad. The character also resembles the fleeting moment of a barefooted striker poised to shoot, evoking the original beauty and power of football – a game that united people across the wo