Business Wire

Valbiotis Announces Completion of Recruitment for the Phase II/III REVERSE-IT Clinical Study With TOTUM•63 Against Prediabetes, in Partnership With Nestlé Health Science

Share

Regulatory News:

Valbiotis (FR0013254851 – ALVAL, PEA/SME eligible) (Paris:ALVAL), a Research and Development company committed to scientific innovation for preventing and combating metabolic and cardiovascular diseases, announces that it has completed the recruitment of 600 volunteers for the international multicenter Phase II/III REVERSE-IT clinical study on TOTUM•63.

This randomized, placebo-controlled study evaluates the efficacy of TOTUM•63, a plant-based active substance, in a population with impaired glucose metabolism, from prediabetes to untreated type 2 diabetes (early stage). The primary objective will be the reduction of fasting blood glucose levels after 24 weeks of TOTUM•63 supplementation compared to placebo. The results will be communicated at the end of the study.

The Phase II/III REVERSE-IT study was co-designed by the Valbiotis and Nestlé Health Science medical and regulatory teams to demonstrate the efficacy of TOTUM•63 against prediabetes and untreated type 2 diabetes (early stage), as part of the global strategic partnership between the two companies. REVERSE-IT should confirm the positive results of the Phase II clinical study already obtained in a similar population with TOTUM•63.

Murielle CAZAUBIEL, Director of Medical, Regulatory and Industrial Affairs and member of the Valbiotis Board of Directors, commented: “We have reached a very important milestone in the development of TOTUM•63 with the completion of enrollment in the Phase II/III REVERSE-IT study. With 600 volunteers enrolled in more than 50 centers worldwide, REVERSE-IT is among the most ambitious studies of early dysglycemia, from prediabetes to early-stage type 2 diabetes, using non-drug approaches. We would like to thank all the teams involved in this project, as well as our partner Nestlé Health Science. With a highly demanding design, REVERSE-IT was developed to provide comprehensive and robust efficacy data on these populations in preparation for the TOTUM•63 market launch.”

The randomized, double-blind, placebo-controlled Phase II/III REVERSE-IT study includes 600 people with impaired glucose metabolism, from prediabetes to untreated type 2 diabetes (early stage). It should confirm the efficacy of TOTUM•63 at a dose of 5 g/day (3 daily intakes) for 24 weeks on blood glucose abnormalities and other metabolic risk factors for type 2 diabetes, compared to a placebo. The protocol will evaluate the effect of TOTUM•63 on fasting blood glucose, the primary endpoint of the study, as well as on a number of secondary endpoints of interest, including two-hour blood glucose and anthropometric parameters (body weight, waist circumference and body fat mass).

About TOTUM•63
TOTUM•63 is a unique and patented combination of 5 plant extracts that targets the pathophysiological mechanisms of type 2 diabetes.
TOTUM•63 has already been shown to be safe and effective in healthy volunteers in a Phase I/II clinical study. Results from a randomized, placebo-controlled, international Phase II study showed that when compared to the placebo, TOTUM•63 reduced fasting blood glucose and 2-hour blood glucose levels, two risk factors for type 2 diabetes.
In these subjects, who were also abdominally obese, TOTUM•63 also significantly reduced body weight and waist circumference.
TOTUM•63 benefits from intellectual property validated by patents in the world's leading markets: Europe (covering 39 countries), the United States, Russia, China, Japan, Mexico, Indonesia, Israel, South Africa, New Zealand and national phases are still underway in a dozen other countries including Brazil and Australia. Production capacity for TOTUM•63 has been validated in accordance with North American and European standards. TOTUM•63 already has marketing authorizations related to its status in Europe.
In February 2020, Valbiotis signed a long-term global strategic partnership with Nestlé Health Science for the development and worldwide commercialization of TOTUM•63. This unique partnership in the field of Health Nutrition foresees the marketing of TOTUM•63 by Nestlé Health Science on a worldwide scale, possibly before obtaining a health claim depending on the area. They will also fund the final stages of development of TOTUM•63.

About Valbiotis
Valbiotis is a Research & Development company committed to scientific innovation for preventing and combating metabolic and cardiovascular diseases in response to unmet medical needs.
Valbiotis has adopted an innovative approach, aiming to revolutionize healthcare by developing a new class of health nutrition products designed to reduce the risk of major metabolic diseases, relying on a multi-target strategy enabled by the use of plant-based terrestrial and marine resources.
Its products are intended to be licensed to players in the health sector.
Created at the beginning of 2014 in La Rochelle, the Company has forged numerous partnerships with leading academic centers. The Company has established three sites 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 as an "Innovative Company" by the BPI label. Valbiotis has also been awarded "Young Innovative Company" status and has received major financial support from the European Union for its research programs via the European Regional Development Fund (ERDF). Valbiotis is a PEA-SME eligible company.
For more information about Valbiotis, please visit: www.valbiotis.com

Name: Valbiotis
ISIN Code: FR0013254851
Ticker symbol: ALVAL
EnterNext© PEA-PME 150

This press release contains forward-looking statements about Valbiotis’ objectives. Valbiotis considers that these projections are based on rational hypotheses and the information available to Valbiotis at the present time. However, in no way does this constitute 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 Financial Markets Regulator (AMF) on May 19, 2022. 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, or a solicitation to purchase or subscribe to Valbiotis’ shares or financial securities in any country.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Corporate Communication / Valbiotis
Carole ROCHER
Communication and Public Affairs Director
+33 6 77 82 56 88

Marc DELAUNAY
Communication Manager
+33 5 46 28 62 58
media@valbiotis.com

Financial communication / Actifin
Stéphane RUIZ
Associate Director
+33 1 56 88 11 14
sruiz@actifin.fr

Media Relations / PrPa
Damien MAILLARD
Director of Operations
+33 6 80 28 47 70
damien.maillard@prpa.fr

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(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

Dubai Electricity and Water Authority PJSC announces AED 12.08 billion revenue and 3.30 billion net profit in the first half of 202213.8.2022 09:59:00 CEST | Press release

Dubai Electricity and Water Authority PJSC (ISIN: AED001801011) (Symbol: DEWA), the Emirate of Dubai’s exclusive electricity and water services provider, which is listed on the Dubai Financial Market (DFM), today reported its second quarter 2022 financial results, recording quarterly revenue of AED 7.01 bn and net profit of AED 2.61 bn. For the first half of 2022, DEWA’s revenue is AED 12.08 bn and net profit is AED 3.30 bn. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220812005416/en/ Dubai Electricity and Water Authority PJSC announces AED 12.08 billion revenue and 3.30 billion net profit in the first half of 2022 (Photo: AETOSWire) DEWA’s first half revenue increase of 15% to AED 12.08 bn was mainly driven by an increase in energy and water demand in Dubai. During the first half of 2022 energy demand increased by 6.3% and water demand by 6.4% compared to the same period in 2021. Revenue of DEWA’s majority owned subsidia

Mary Kay Inc. Continues Its Support of Women’s Empowerment at the International Women’s Forum Cornerstone Conference in Chile12.8.2022 18:33:00 CEST | Press release

Mary Kay Inc. continues its support of women’s entrepreneurship, empowerment and thought leadership as a sponsor of the 2022 International Women’s Forum (IWF) Cornerstone Conference. Taking place on 17-18 May in Santiago, the Conference convened global decision makers who explored the most pressing challenges to progress on gender equality for the Latin American region. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220812005257/en/ IWF Latinobarómetro MKI Latin American Women Democracy & Society from a Gender Perspective Research (Graphic: Mary Kay Inc.) For the first time ever, IWF commissioned groundbreaking research as part of its annual conference programming with funding by Mary Kay. Conducted by the Latinobarómetro founded by Marta Lagos, this research, titled “Latin American Women: Democracy & Society from a Gender Perspective,” is the first-ever analysis of a quarter of a century (1995-2020) of public opinion and at

Ipsen Completes Acquisition of Epizyme Expanding Its Portfolio in Oncology12.8.2022 17:35:00 CEST | Press release

Regulatory News: Disclaimer: Intended for international media and investor audiences only Ipsen (Euronext: IPN; ADR: IPSEY) today announced the closing of the definitive merger agreement under which Ipsen has acquired Epizyme, Inc. (Epizyme). Pursuant to the transaction, Ipsen acquires all outstanding shares of Epizyme for $1.45 per share plus a contingent value right (CVR) of $1.00 per share. Epizyme now operates as ‘an Ipsen company’ at deal close. As part of the transaction, Ipsen acquires Epizyme’s lead medicine, Tazverik® (tazemetostat), a first-in-class, chemotherapy-free EZH2a inhibitor, which was granted Accelerated Approval by the U.S. Food and Drug Administration (FDA) in 2020. It is currently indicated for adults with relapsed or refractory follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies, and for adult patients with relapsed or refractory follicular lymphom

Budweiser Celebrates 100 Days to The FIFA World Cup™ by Partnering with Messi, Neymar Jr. and Sterling to Drop Hundreds of Prizes For Fans Around the World12.8.2022 13:00:00 CEST | Press release

Tomorrow, Budweiser, an Anheuser-Busch InBev (AB InBev) global brand will “drop” prizes in select destinations in the lead up to the biggest global sporting event. As the Official Beer of the FIFA World Cup, Budweiser is giving fans the once-in-a-lifetime chance to experience the FIFA World Cup in person by dropping hundreds of red prize boxes in major cities that include signed memorabilia, a year’s supply of Budweiser, and the grand prize of a trip to the tournament. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220812005051/en/ Budweiser's QR code (Graphic: Business Wire) Beginning August 13, coordinates leading to prize boxes will be revealed to fans who scanned exclusive Budweiser QR codes. These exclusive QR codes were shared on Budweiser and athlete partner social accounts earlier this week, spurring curiosity and excitement from eager fans. QR codes appeared in locations commemorating Messi, Neymar Jr. and Sterling;

Q4 Inc. Announces Second Quarter 2022 Results12.8.2022 13:00:00 CEST | Press release

Q4 Inc. (TSX:QFOR) (“Q4” or the “Company”), a leading capital markets communications platform, today announced its financial results for the three and six months period ended June 30, 2022. All amounts are expressed in US dollars unless otherwise stated. “The second quarter results show our continued progress against our overall strategy and vision,” said Darrell Heaps, CEO of Q4. “We achieved double digit recurring revenue growth, driving product adoption with higher ARPA expansion growth, as our customers continued to renew subscriptions at record levels and increase their spend with Q4. Given the challenging macro environment, and with our peak investment period behind us, we are accelerating our path to profitability. With a focus on expanding our operating leverage, initiatives are underway to improve sales efficiency and utilize low cost geographies to drive down operating expenses. Combined with our gross margin expansion, these will bring forward our commitment to be cash and E