Valbiotis Announces the Large Success of the REVERSE-IT International Multicentric Phase II/III Clinical Study on TOTUM•63

Proven Efficacy on the Main Risk Factor of Developing Type 2 Diabetes - Seite 2

The REVERSE-IT study was co-designed with Nestlé Health Science's medical teams as part of the global strategic partnership between Valbiotis and Nestlé Health Science signed in February 2020. Under this agreement, positive results of the REVERSE-IT study on the primary endpoint trigger a lump sum payment of CHF 4 million from Nestlé Health Science to Valbiotis. This milestone payment from Nestlé Health Science will occur upon submission of the full study report during the summer.

The REVERSE-IT study and its results on its primary endpoint

The randomized and placebo-controlled REVERSE-IT Phase II/III study included 636 people with impaired glucose metabolism, ranging from prediabetes to untreated type 2 diabetes (early stage).

The volunteers were divided into three equally balanced arms, each with more than 200 participants. In the intervention arm, participants were supplemented with TOTUM•63 at a dose of 5 g/day in three daily intakes. To complete the study, a second open-label arm evaluated a similar dose of 5 g of TOTUM•63 in two daily intakes.

The REVERSE-IT study met its two objectives on its primary endpoint, fasting blood glucose, with a high statistical significance on the data obtained in ITT (Intention To Treat):

• the reduction in fasting blood glucose with TOTUM•63 after 6 months of supplementation with a 5g/day dose in three daily intakes, compared to placebo (p=0.015);
• the reduction in fasting blood glucose with TOTUM•63 after 6 months of supplementation with a 5g/day dose in two daily intakes, compared to placebo.

The statistical analysis conducted in the per protocol population also confirms the statistical significance of these two results.

At the end of all the analyses, the comprehensive results of the study will be communicated in a subsequent press release, on the secondary endpoints and exploratory analysis, and submitted for presentation at international congresses and publication in international peer-reviewed journals.

About TOTUM•63

TOTUM•63 is a unique and patented combination of 5 plant extracts that targets the pathophysiological mechanisms of type 2 diabetes.
TOTUM•63 benefits from intellectual property validated by patents in the world's leading markets: Europe (covering 39 countries), the United States, Russia, China, Japan, Mexico, Indonesia, Israel, South Africa, New Zealand, Singapore, Saudi Arabia, Australia, Algeria, Ukraine, Malaysia, Chile, India, South Korea and national phases are currently ongoing in Brazil, Argentina, Canada, Thailand, Qatar and the United Arab Emirates