VALBIOTIS: Authorization to Launch the International Phase II/III REVERSE-IT Clinical Study on TOTUM-63, to Reduce Type 2 Diabetes Risk Factors
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.
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.
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.
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
MEDIA RELATIONS / MADIS PHILEO
Guillaume DE CHAMISSO
+33 6 85 91 32 56
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
ISAE-SUPAERO Continues Its Involvement in the InSight Mission and Reveals the Results of Its Research From Planet Mars5.8.2021 11:24:00 EEST | Press release
Launched by NASA in May 2018, the InSight mission is pursuing the objective of studying the internal structure of the planet Mars using the SEIS seismometer developed by ISAE-SUPAERO. Three studies, published on July 23 in the journal Science, reveal, for the first time, an estimate of the size of the core, the thickness of the crust and the structure of the mantle of the red planet. Three of the co-authors, Raphaël Garcia, Mélanie Drilleau and Nicolas Compaire, are from ISAE-SUPAERO, and are collaborating on this major seismic exploration project, which represents a significant step in the understanding of the formation and thermal evolution of Mars. Before this mission, the internal structure of Mars was still poorly understood. The details of the planet's internal structure and the depth of the boundaries between crust, mantle and core were completely unknown. With the successful deployment of the SEIS experiment on the surface of Mars in early 2019, the scientists collected and ana
Yamaha Motor Earnings Continue to Rise in Second Quarter5.8.2021 11:12:00 EEST | Press release
Yamaha Motor Co., Ltd. (TOKYO:7272) announces its consolidated business results for the first half of fiscal 2021. Net sales for the consolidated accounting period for the first six months of the fiscal year ending December 31, 2021 were 920.1 billion yen (an increase of 234.6 billion yen or 34.2% compared with the same period of the previous fiscal year) and operating income was 109.2 billion yen (an increase of 90.1 billion yen or 471.9%). Ordinary income was 115.1 billion yen (an increase of 94.3 billion yen or 454.8%) and net income for the period attributable to owners of parent was 93.1 billion yen (compared to a quarterly net loss of 2.8 billion yen in the same period of the previous fiscal year). For net sales, the worldwide spread of COVID-19 infections since March last year led to lower unit sales and production numbers, but the impacts have diminished over this first half of the fiscal year and demand has recovered in all business segments, resulting in higher sales overall.
Nordic Enterprises Seek Help with Ransomware Schemes5.8.2021 11:00:00 EEST | Press release
Facing a dramatic rise in cyberattacks, enterprises in the Nordic countries are turning to cybersecurity services and solutions providers to thwart ransomware and other malicious intrusions, according to a new report published today by Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm. The 2021 ISG Provider Lens™ Cybersecurity – Solutions & Services Report for the Nordics finds businesses in the region looking for support to keep cybercriminals from stealing intellectual property and personal information. Enterprises in the Nordics, including those in the healthcare, hospitality, IT and finance industries, saw a significant increase in cyberattacks in 2020. “High-profile cyberattacks in the Nordics point to growing efforts by international cybercriminals to disrupt businesses and cause harm,” said Roger Albrecht, co-leader of ISG Cybersecurity. “In the coming years, their main targets are likely to be banks, payment providers, insure
Altium Advances STEM Education with Expanded Curriculum and New Partnerships5.8.2021 10:00:00 EEST | Press release
In September 2020, Altium LLC, the leading printed circuit board (PCB) software company, launched Upverter Education, a free distance learning initiative to support STEM educators. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210805005356/en/ Start your school year right with Upverter Education, an award-winning electronics design curriculum. (Photo: Altium LLC) The free Electronics Design Essentials program was designed for high school STEM teachers covering everything from engineering to robotics, with guided courses, certification and Upverter, an easy-to-use web-based tool for electronics design. Rea Callender, Vice President of Altium Education, elaborates, “Through Altium’s education initiatives, beginning with Upverter Education, we are introducing students of all ages to electronics design and sparking passion in people where they never knew it existed. You can’t have a passion for something if you don’t know it ex
Servify's Massive Growth Leads to Expansion of Global Team with Key Hires Across Business Domains5.8.2021 08:30:00 EEST | Press release
Servify, a leading provider of Extended Care and Product Protection solutions using its global, AI-enabled, digital platform, has announced hiring of senior leaders across regions and functions to drive its global expansion. Arun Verma, MS Kalsi, Kevin Cundiff, Edward Lee, Swetha Prashant, Peter Duesing, Sanghoon (Sam) Kwon, Hussein Hussein and Sergey Odinets have all been hired to bolster various verticals and regions within the organisation. Arun Verma, with more than 20 years of experience, was appointed as the Chief Human Resources Officer. He has championed impressive success in people management across distinctly diverse industries such as Technology & Services, Finance, Management Consulting & FMCG. He worked as CHRO and Head of Administration of Beetel before Servify, and with the likes of Xerox India, McKinsey & Co., Reliance Capital Limited, and CavinKare in the past. Makhan Singh Kalsi, also known as M S Kalsi, joins Servify as its Chief Service Officer after previously serv
Vifor Pharma reports strong H1 2021 growth, on track to meet full year guidance15.8.2021 08:00:00 EEST | Press release
Regulatory News: Vifor Pharma Group reported profitable revenue growth in H1 supported by a strong recovery in Ferinject® / Injectafer® with sales up 22.8% at CER as a result of improved patient access as COVID-19 restrictions eased in key markets. Based on the solid results in H1 2021, the Group is confident of achieving its full year guidance. FINANCIAL PERFORMANCE2: CONTINUED OVERALL GROWTH Reported net sales of CHF 859.3 million, up 1.5% (up 5.0% at CER) EBITDA of CHF 281.0 million, up 0.2% (up 5.3% at CER). Excluding other income, EBITDA increased 9.4% (up 15.0% at CER) Other income of CHF 20.4 million, down 51.7% due to lower income from partnering and other activities Gross profit margin of 62.5%, up 1.4 percentage points driven by higher share of sales from the iron portfolio Net profit attributable to shareholders of Vifor Pharma Ltd. of CHF 124.4 million, driven by lower depreciation, amortization and impairment, as well as the strong net financial result in H1 2021 Strong ba
Kyoto Semiconductor Co., Ltd. Launches New Photodiode Demonstrating Superior Performance With Semtech’s Linear Transimpedance Amplifier5.8.2021 08:00:00 EEST | Press release
Kyoto Semiconductor Co., Ltd. (President and CEO Tsuneo Takahashi, Head office: Fushimi-ku, Kyoto city), a leading optical device solution manufacturer with world-class technologies and Japanese quality, announced its collaboration with Semtech Corporation (Nasdaq: SMTC), a leading supplier of high performance analog and mixed-signal semiconductors and advanced algorithms. Kyoto Semiconductor has chosen to pair their new KP-A avalanche photodiode*1, KPDEA13C with Semtech’s GN1089 transimpedance amplifier*2 to enable long distance optical communication. "The pairing of Semtech’s transimpedance amplifier GN1089 with Kyoto Semiconductor’s KPDEA13C was ideal to optimize the performance,” said Tsuneo Takahashi, Kyoto Semiconductor president and CEO. “Through the joint collaboration, the KPDEA13C now includes a fast response suitable for a variety of optical needs.” Kyoto Semiconductor’s KPDEA13C is front side illuminated, highly sensitive and mounted on an interposer board for ease of assem
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