VALBIOTIS Confirms the Publication of the Results from International Phase IIA Clinical Study Evaluating VALEDIA® for the Risk Reduction of Type 2 Diabetes, by Mid-2019
- Last subject included in the the Phase IIA clinical study at the beginning of November 2018
- Results to be published mid-2019, as precedently announced
- Objective: obtaining the world’s first proprietary health claim asserting efficacy in reducing the risk of type 2 diabetes
LA ROCHELLE, France –(BUSINESS WIRE)
VALBIOTIS (Paris:ALVAL) (FR0013254851 – ALVAL / PEA/SME eligible), a French Research & Development company committed to scientific innovation for preventing and combating metabolic diseases, confirms the publication of the results evaluating VALEDIA® for the risk reduction of type 2 diabetes, by mid-2019.
Sébastien PELTIER, Chairman of the VALBIOTIS Board of Directors stipulates: “In recruiting the last subject for the Phase IIA clinical study evaluating the effects of VALEDIA®on the risk reduction of type 2 diabetes, VALBIOTIS has crossed an extremely significant milestone. We are happy that our development plan is proceeding as we predicted and we are now confidently awaiting the results of this study for mid-2019. We would like to thank all the subjects participating in this study, as well as the investigators. VALEDIA®is a completely innovative health product which represents a new approach to preventive health care, where modifiable risk factors can be targeted from the very first symptoms.“
VALEDIA®, a product for the prevention of type 2 diabetes
The Phase IIA clinical study is a randomized, multi-center, double-blind, placebo-controlled study conducted on the main active ingredient of VALEDIA®, TOTUM-63.
Authorization was granted by the French authorities in November 2016. Prediabetic subjects were recruited based on two criteria: high fasting glycemia levels and glucose intolerance, with abdominal obesity and moderate, untreated hypertriglyceridemia.
At the start of 2018, VALBIOTIS decided to open three European recruitment centers in addition to its existing French centers, in order to obtain clinical data from across Europe. This recruitment is now complete and the results of the study are expected by the middle of 2019.
In particular, this study will enable the effects of the main active ingredient of VALEDIA® to be evaluated against three risk factors, recognized by the FDA (Food and Drug Administration, United States): fasting glycemia, post-prandial glycemia (glucose intolerance) and insulin resistance.
With these results, the risk factor can then be validated and used in our approach to European and North-American authorities. VALBIOTIS specifies that the validation of just one of these three risk factors would be sufficient to obtain a health claim related to reducing the risk of type 2 diabetes, therefore positioning VALEDIA® as the first product in the world to be specifically aimed at prediabetics.
The main active ingredient of VALEDIA®, TOTUM-63 is based on a specific and patented combination of 5 plant extracts selected for their multi-target effect on the metabolism.
VALEDIA® has already been the focus of a Phase I/II clinical study, the results of which were presented at the 77th edition of the American Diabetes Association (ADA) scientific sessions, in June 2017.
VALBIOTIS is a French Research & Development company committed to scientific innovation for preventing and combating metabolic diseases. Its products are made for manufacturers in the agri-food and pharmaceutical industries. 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).
Find out more about VALBIOTIS:
ISIN code: FR0013254851
Mnemonic code: ALVAL
Carole Rocher / Marc Delaunay
+33 5 46 28 62 58
Stéphane Ruiz, +33 1 56 88 11 14
Guillaume De Chamisso, +33 6 85 91 32 56
Rebecca John / Patrick Till
+1 646 378 2935
[email protected] / [email protected]
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