18 May 2018 - - La Rochelle, France-based research and development company Valbiotis (Paris: ALVAL) has received authorization from an independent review board to launch the international REVERSE-IT (Phase IIB1) clinical study of Valedia in the US, the company said.
Simultaneously, discussions have been initiated with the Food and Drug Administration for a health claim regarding the reduction of the risk of Type 2 Diabetes.
REVERSE-IT is an international, multicenter, randomized, double-blind, Phase IIB1 placebo-controlled study of 150 prediabetic individuals to determine the most efficient dose of Valedia.
The American part of the study will be conducted in in Miami, Florida and Chicago, Illinois.
Valedia, designed for prediabetics, improves insulin sensitivity and aims to reduce the risk of Type 2 Diabetes. In a Phase I/II clinical study, Valedia has demonstrated safety and early evidence of efficacy.
Valbiotis is committed to scientific innovation for preventing and fighting against metabolic diseases.
Its products are made for manufacturers in the agri-food and pharmaceutical industries.
The company particularly focuses on solutions to prevent type 2 diabetes, nonalcoholic steatohepatitis, obesity, and cardiovascular diseases.