France-based Valbiotis has revealed positive results for the Phase IIA study of Valedia (active substance: TOTUM-63), which assessed the product's efficacy in a pre-diabetic population, compared to placebo, it was reported on Friday.

In this population, the product decreased fasting and post-prandial blood glucose levels. It also decreased body weight and waist circumference. The product is the first clinically validated product designed for pre-diabetic people, to reduce several risk factors for type 2 diabetes. These results allow the concomitant launch of the last two Phase IIB clinical studies (REVERSE-IT and PREVENT-IT), to receive the first health claims for the risk reduction of type two diabetes in Europe and North America. This regulatory process does not require a Phase III study. Commercialisation is scheduled for 2021.

Professor Jean-Marie BARD, hospital practitioner and professor of Fundamental and Clinical Biochemistry at the University of Nantes, scientific expert for the study said, 'The reduction of fasting blood glucose and blood glucose 2 hours after a glucose intake is a new advance for pre-diabetics. These results show the impact of VALEDIA on metabolism, with even a decrease in body weight and waist circumference, usually hard to demonstrate in clinical studies. With such data, VALEDIA proves its efficacy to reduce type 2 diabetes risk factors.'