French research and development company Valbiotis has received approval from IntegReview, an independent review board (IRB) accredited by American health authorities, to conduct the REVERSE-IT trial in the US.
The REVERSE-IT trial is a Phase IIBl clinical study of Valedia for the treatment of Type 2 Diabetes.
The global, placebo-controlled trial seeks to determine the most efficient dose of Valedia on prediabetic subjects.
Altogether 150 prediabetic individuals will be enrolled in the trial, which will be carried out in two centres in the US in Miami, Florida and Chicago, Illinois.
Valbiotis CEO Sébastien Peltier said: “The acceleration of our development in the US marks the beginning of a key phase for Valbiotis.
“The authorisation from the American authorities for the Valedia clinical study supports our access to these markets, and in particular to the prediabetes market, which affects more than 86 million people in the US.”
Valedia is capable of improving insulin sensitivity and seeks to reduce the risk of Type 2 Diabetes.
It has been developed for prediabetic individuals and will apply for a health claim issued by the authorities in the US, Canada and Europe.
In a Phase I/II clinical trial, Valedia has already showed safety and early evidence of efficacy.
In November last year, Valbiotis secured authorisation from the French National Agency for Medicines and Health Products (ANSM)to conduct the REVERSE-IT trial in France.
The company has also started discussions with the US Food and Drug Administration (FDA) for obtaining a health claim for Valedia in reducing the risk of Type 2 Diabetes.