LA ROCHELLE, France--(BUSINESS WIRE)--Regulatory News:
VALBIOTIS (FR0013254851 – ALVAL / PEA/SME eligible) (Paris:ALVAL), a French Research & Development company committed to scientific innovation for preventing and combating metabolic diseases, announces the completion of the international Phase IIA clinical study evaluating VALEDIA® in prediabetic subjects, after the final follow-up visit was conducted with the last patient. VALBIOTIS will present the results of this study before 31 July 2019.
"Announcing the results of the Phase IIA clinical trial represents a major development for VALBIOTIS. We would like to thank all those who participated in the study as well as our academic and scientific partners for their valuable contributions. We are confident in the results, which will evaluate the efficacy of VALEDIA® on the target population of prediabetics for the first time," comments Murielle CAZAUBIEL, Head of Development and Medical Affairs at VALBIOTIS.
The international Phase IIA, multicentric study was randomized, double-blind placebo-controlled, and included 66 prediabetic subjects1. The study evaluates the efficacy of TOTUM-63, the active ingredient of VALEDIA®, in reducing one or more of the 3 risk factors for type 2 diabetes, from the 3 criteria chosen by the Food and Drug Administration2 to obtain a healthclaim: insulin resistance, moderate fasting hyperglycemia and glucose intolerance.
In addition to these prediabetes results, the study will evaluate other physiological parameters, including, for example, triglyceride regulation or intestinal microbiota composition. This additional data will help confirm the potential of VALEDIA® for other applications.
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.
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:
ISIN code: FR0013254851
Mnemonic code: ALVAL
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.
1 Divided into two arms, for a period of 6 months. The
subjects who were randomized to the supplemented arm received a 5g dose
of VALEDIA® each day.
2 Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims, FDA, 2009, www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm073332.htm