Valbiotis SA announced the large success of the REVERSE-IT Phase II/III clinical study on TOTUM-63. Conducted in 636 prediabetic and untreated type 2 diabetic patients (early stage), this international, multicentric, randomized and placebo-controlled study confirms the efficacy of TOTUM-63 in reducing fasting blood glucose at 2 and 3 intakes per day. These positive results trigger a lump sum payment of CHF 4 million from Nestlé Health Science as part of the global strategic partnership.

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. 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 Production capacity for TOTUM-63 has been validated in accordance with North American and European standards.

TOTUM-63 already has marketing authorizations related to its status in Europe. In February 2020, Valbiotis signed a long-term global strategic partnership with Nestlé Health Science for the development and worldwide commercialization of TOTUM-63. This unique partnership in the field of Health Nutrition foresees the marketing of TOTUM-63 by Nestlé Health Science on a global scale, possibly before obtaining a medical clearance depending on the area.

They will also fund the final stages of development of TOTUM-63.