Business Wire

VALBIOTIS Succeeds in the Industrial Production of VALEDIA®, a Major Scientific Innovation for Prediabetic People, in Collaboration with the Pierre Fabre Group

Del

Regulatory News:

VALBIOTIS (FR0013254851 – ALVAL / PEA/SME eligible), a French Research & Development company committed to scientific innovation for preventing and combating metabolic diseases, announces the successful industrial production of VALEDIA® (active substance TOTUM-63), the most advanced product in the VALBIOTIS portfolio. This achievement is the result of a collaboration with the Pierre Fabre group, a world-renowned expert in the industrial production of plant-based active substances.

Since securing industrial property rights in Europe and the United States, VALBIOTIS has made another major breakthrough by demonstrating its capacity to produce VALEDIA® industrially, and in accordance with the regulations governing these two markets.

Sébastien Peltier, CEO of VALBIOTIS, comments: "The industrial production of VALEDIA ® has come at the best possible time for VALBIOTIS, after obtaining strong preclinical and clinical results and securing the industrial property rights, in the lead-up to the publication of our Phase IIA clinical results. This is an important milestone, thus completing our health claim application and supporting our negotiations with a partner company to market the product in 2021. This development confirms the sustainability of our project to market plant-based products which target the causal mechanisms of metabolic diseases. To achieve this, we are following the regulatory process for dietary supplements with a health claim, while maintaining almost pharmaceutical-grade development standards."

VALEDIA® will be the first of a new class of products, aiming to prevent and combat metabolic diseases.

Industrial batches for future studies

VALBIOTIS is currently developing VALEDIA ® for two labels: prediabetes and hepatic steatosis. The results of the Phase IIA clinical trial for prediabetes are expected by 31 July, 2019. They will be followed in the second half of the year by the launch of the European Phase IIB clinical study (REVERSE-IT) and the Phase IIB study (PREVENT-IT) in North America. The data from these studies will be used to submit the application to European and North American regulatory authorities, for a health claim to reduce the risk of type 2 diabetes, with a view to marketing the product in 2021.

Murielle Cazaubiel, Director of Development and Medical Affairs at VALBIOTIS, comments: "The success of this industrial production means we can progress to the next stages of clinical development with complete confidence. The new production capacities established with the Pierre Fabre group will be used in our two upcoming confirmation studies. This collaboration has enabled VALBIOTIS to benefit from leading expertise in the production of plant-based active substances, from extraction to standardization, ensuring that these results can be reproduced with both large and small quantities."

“In 2015, we put our expertise in extracting plant-based active substances at the service of VALBIOTIS and accompanied them in their development. We produce 3 plant extracts that make up VALEDIA ® at our Gaillac (Tarn) extraction site. Today, we are happy to accompany them in this industrial transposition by manufacturing the capsules on our Cahors (Gers) production site specialized in phytotherapy and aromatherapy,” adds François MACAREZ, Business Developer at Pierre Fabre Médicament.

About TOTUM-63, the active substance of VALEDIA®

Prediabetes is a growing public health issue worldwide that has been acknowledged by international organizations. Without appropriate management, 70% to 90% of prediabetic subjects will develop type 2 diabetes.

VALEDIA® intend to be be the first natural and clinically proven solution specifically designed for prediabetics. VALEDIA® contains the active substance TOTUM-63, a unique and patented combination of 5 plant extracts, with high potential to target the physiopathological mechanisms of type 2 diabetes.

The launch of VALEDIA® is planned for 2021, with a health claim for reducing the risk 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 first international Phase IIA study are expected before 31 July 2019.

ABOUT VALBIOTIS

VALBIOTIS is a French Research & Development company committed to scientific innovation for preventing and combating metabolic diseases. Its products are made for major players in the health care sector. VALBIOTIS particularly focuses on solutions to prevent type 2 diabetes, NASH (nonalcoholic steatohepatitis), obesity and cardiovascular diseases.

VALBIOTIS was founded in La Rochelle in early 2014 and has formed numerous partnerships with top academic centers in France and abroad, including La Rochelle University, the CNRS and Clermont Auvergne University located in Clermont-Ferrand. These partnerships have enabled Valbiotis to benefit from strong financial leverage, particularly thanks to experts and technical partners who support its projects. The Company has established three sites in France – Périgny, La Rochelle (17) and Riom (63) – and an American office in Boston (MA).

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: http://valbiotis.com/

Name: VALBIOTIS
ISIN code: FR0013254851
Mnemonic code: ALVAL

Disclaimer

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 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 5 April 2017 (application number I.17-012), as well as in the 2017 annual financial report, filed with AMF on 3 April 2018. These documents are available on the Company's website (www.valbiotis.com). VALBIOTIS does not accept any liability regarding the update or revision of these forward-looking statements. 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.

Contact information

VALBIOTIS
CORPORATE COMMUNICATION
Carole Rocher /
Marc Delaunay
+33 5 46 28 62 58
medias@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

UNITED STATES
SOLEBURY TROUT
Rebecca John / Patrick Till
+1 646 378 2935
rjohn@troutgroup.com
ptill@troutgroup.com

Om 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.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Boehringer Ingelheim and OSE Immunotherapeutics Announce Dosing Of the First Patient in a Phase 1 Trial of SIRPα Antagonist Monoclonal Antibody, BI 765063, in Patients with Advanced Solid Tumors17.6.2019 16:00:00 CESTPressemelding

Boehringer Ingelheim and OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnémo: OSE) today announce that the first patient has been dosed in the first-in-human Phase 1 clinical trial evaluating BI 765063, formerly OSE-172, a first-in-class monoclonal antibody antagonist of SIRPα, being studied in patients with advanced solid tumors. The Phase 1 study is a dose finding study of BI 765063, a myeloid checkpoint inhibitor, administered as a single agent and in combination with Boehringer Ingelheim’s monoclonal antibody PD-1 antagonist BI 754091, a T-lymphocyte checkpoint inhibitor. “We are very pleased with the progress achieved on BI 765063’s program and having the first patient dosed marks a significant milestone in the product’s development. The advancement of a myeloid cell checkpoint blocking monoclonal antibody into the clinic exemplifies Boehringer Ingelheim’s commitment to the next wave of innovation in cancer immunology therapies, with the goal of meaningfully improving outcomes fo

MagicStay Raises €3 Million to Accelerate Its International Development17.6.2019 15:58:00 CESTPressemelding

The apartment rental platform dedicated to business travelers, MagicStay.com , announces its full integration into the main business travel booking tools and a €3 million A-series to pursue its development, bringing the amounts raised to more than €8 million since its launch in 2013. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190617005644/en/ William Lecerf and Valéry Linyer, co-founders of MagicStay (Photo: MagicStay) "This fundraising will allow us to recruit talent to accelerate our growth. We want to sign a quarter of the major French companies and approach one million homes before the end of the year, thanks to the exclusive technologies we now have at our disposal", says Valéry Linÿer, CEO and co-founder, who adds: "We have four main advantages over our competitors: we meet the challenges of duty of care, we are able to customize our tool to meet the constraints of each large company for short and long stays, we ha

EURid Shows a 94% Reduction of Its Footprint since 201217.6.2019 15:32:00 CESTPressemelding

EURid, the not-for-profit organisation that operates the .eu and .ею top-level domains, is the first European TLD registry that registered for the EU Eco-Management and Audit Scheme (EMAS) from 2011. Since then, EURid has regularly assessed the environmental impact of its activities and monitored the compliance of its policies and procedures. As over the past four years, in Q2 2019 EURid was audited for the CO2 emissions of the previous year, resulting in an overall footprint of 135 tons CO2eq, which shows a 94% reduction since 2012. “We have achieved carbon neutrality via several actions and the compensation of the audited emissions. We were and are still among the first in our sector to report on our commitment to protect the environment”, commented CEO Marc Van Wesemael. Through EMAS, EURid has had the opportunity to support a multitude of global sustainability initiatives, like the Ugandan Borehole Project, Ecomapuà Project in the Amazon, the Dak Rung Hydropower Project in Vietnam,

Animation, Sound & Vibration – How Visa is Reinforcing Consumer Trust in a Changing Payments World17.6.2019 15:00:00 CESTPressemelding

Visa (NYSE: V) today announced global adoption of its sensory branding suite in 25 countries via more than a dozen new partnerships. The suite is comprised of sound, animation and haptic brand cues that occur with a Visa payment transaction. In a digital world increasingly filled with voice-commands, networked appliances and unattended retail environments, Visa’s sensory branding cues offer new ways to enhance the customer experience and convey the trust and security that the Visa brand represents. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190617005240/en/ Visa was the first major payment brand to introduce multi-sensory branding, which included animation, sound and haptic vibration expressions of its brand. After an extensive creation and selection process that involved focus groups and elimination rounds, Visa landed on a single ‘energetic’ and ‘optimistic’ sound, and complementary animation and haptic vibration. Sinc

Study from Project Management Institute Identifies Six AI Technologies Impacting Project Professionals17.6.2019 14:40:00 CESTPressemelding

Project Management Institute (PMI) today released its 2019 Pulse of the Profession® In-Depth Report: AI Innovators: Cracking the Code on Project Performance. The report provides an in-depth look at how artificial intelligence (AI) is impacting organizations and the project management profession. Findings reveal that AI disruption is happening and at a large scale: 81 percent of respondents report their organization is being impacted by AI technologies; 37 percent say adopting AI technologies is a high priority for their organization; and project professionals say they expect the proportion of the projects they manage using AI will jump from 23 to 37 percent over the next three years. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190617005558/en/ These insights from a survey of 551 project management practitioners globally show that the presence of AI technologies will continue to grow, requiring shifts in how projects are m

RIBOMIC Announces Positive Top-Line Results from the Phase 1/2a Clinical Trial of RBM-007 (SUSHI Study) in Subjects with Wet Age-Related Macular Degeneration17.6.2019 13:15:00 CESTPressemelding

RIBOMIC, Inc., a clinical stage pharmaceutical company specializing in aptamer therapeutics and traded on the Mothers Market of the Tokyo Stock Exchange (Code Number: 4591), today announced positive top-line results from its SUSHI study, Phase 1/2a single ascending dose clinical study of RBM-007, anti-FGF2 aptamer, in nine subjects with wet Age-Related Macular Degeneration (wet AMD). SUSHI study achieved the primary endpoint of safety and tolerability, and also demonstrated efficacy trends in favor of RBM-007. Subjects recruited for the SUSHI Study had wet AMD that was poorly responsive to previous intravitreal anti-VEGF therapy. Through the 56-Day exit visit, excluding one uncompleted case in the last cohort, single dose of RBM-007 demonstrated no dose-limiting toxicities, no systemic or ocular serious adverse events. One subject in Cohort 3 showed anterior inflammation, which was resolved after one day of topical prednisolone treatment. Rescue treatment with anti-VEGF therapy was ava