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VALBIOTIS to present Totum-63 data
LA ROCHELLE, France—VALBIOTIS, a research & development company focusing on treatment and prevention of metabolic diseases, announced today that new preclinical results of Totum-63 obtained independently by Leiden University (Netherlands) will be presented at the 79th scientific sessions of the American Diabetes Association, being held from June 7 - 11 in San Francisco, California.
In a murine model of prediabetes, Totum-63 was shown to reduce inflammation in visceral adipose tissue, one of the pathophysiological mechanisms of metabolic diseases, especially type 2 diabetes. The study also confirmed the efficacy of Totum-63 on sugar and lipid metabolism in the preclinical model.
“This study from Leiden University is important from a scientific standpoint: it demonstrates a new effect of Totum-63, the active substance of lead product candidate Valedia, on visceral adipose tissue inflammation that enriches the multi-target mode of action of Totum-63. On the clinical side, as previously announced, we expect to report the results of the international Phase 2a clinical study of Valedia before July 31st,” said Sébastien Peltier, CEO of VALBIOTIS.
Prediabetes is a growing public health issue worldwide. Without appropriate management, 70% to 90% of prediabetic subjects will develop type 2 diabetes. VALBIOTIS hopes that Valedia will be the first natural and clinically proven solution specifically designed for prediabetics. Valedia’s active substance, Totum-63, is a unique, patented combination of 5 plant extracts, with high potential to target the physiopathological mechanisms of type 2 diabetes.
“Obesity, in both humans and mice, leads to an increase and an activation of macrophages in visceral adipose tissue. These immune cells are involved in maintaining a silent metabolic inflammation, thus reducing the body’s ability to use insulin,” specified Dr. Bruno Guigas, researcher at Leiden University, and the lead investigator of the study. “By reducing this inflammation and increasing insulin sensitivity in adipose tissue, Totum-63, the active substance of Valedia, would contribute to the reduction of the release of lipids into the bloodstream.”
The discovery of this new effect further supports the multi-target mode of action of Totum-63, which was presented at the European Association for the Study of Diabetes (EASD) congress in 2018. This mode of action would already combine preservation of the pancreas, improvement of insulin signaling in muscle and adipose tissue, reduction in hepatic steatosis and improved intestinal microbiota composition.
Totum-63 has already been proven safe and effective in healthy human volunteers during a Phase 1/2 clinical study. The results of the first international Phase 2a study are expected in July 2019. VALBIOTIS is planning the launch of Valedia for 2021.