VALBIOTIS will present the results of the international Phase IIA clinical study of VALEDIA® before 31 July 2019
VALBIOTIS is a French Research & Development company located at 3 sites in France including the Biopole Clermont-Limagne Riom site.
Its products are made for major players in the healthcare sector, in the field of metabolic diseases. VALBIOTIS particularly focuses on solutions to prevent type 2 diabetes, NASH (nonalcoholic steatohepatitis), obesity and cardiovascular diseases.
VALEDIA® is the the most advanced product in the VALBIOTIS pipeline. The launch of VALEDIA® is planned for 2021, with a health claim for reducing the risk of type 2 diabetes.
VALEDIA® intend to 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.
TOTUM-63 has already been proven safe and effective in healthy human volunteers during a Phase I/II clinical study.
Today, VALEDIA® announces the completion of the international Phase IIA clinical study evaluating VALEDIA® in prediabetic subjects. VALBIOTIS will present the results of this study before 31 July 2019.
The international Phase IIA, multicentric study evaluates the efficacy of TOTUM-63, the active ingredient of VALEDIA, 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.
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