ALVAL SA announced the last visit of the last patient enrolled in the Phase II/III REVERSE-IT study on the active substance TOTUM63. This international, multi-center, randomized, placebo-controlled study on 600 untreated prediabetic and type 2 diabetic patients (early stage) is designed to confirm the efficacy of TOTUM63 on impaired glucose metabolism. The first results will be available and communicated before the end of the first half of 2023, in accordance with the schedule announced on September 15, 2022.
TOTUM63 is a unique and patented combination of 5 plant extracts that targets the pathophysiological mechanisms of type 2 diabetes. It has been developed to address a large unmet need: to act on metabolic impairments in the early stages of type 2 diabetes, in particular prediabetes. Prediabetes currently affects nearly 900 million people worldwide, including 128 million in the United States and the five main European1 countries, for whom no non-drug health product yet has solid proof of efficacy.
Nestlé Health Science has the exclusive and global commercial rights to use TOTUM63 in the prediabetes and type 2 diabetes market. The Phase II/III REVERSE-IT randomized, double-blind, placebo-controlled study includes 600 people with impaired glucose metabolism, ranging from prediabetes to untreated type 2 diabetes (early stage). Its primary objective will be to confirm the reduction of fasting blood glucose levels by TOTUM63 taken three times daily for a total daily dose of 5 g over 24 weeks.
The protocol will also evaluate the effect of the same daily dose of TOTUM63 on fasting blood glucose levels but taken twice daily. Finally, REVERSE-IT will evaluate the effects of TOTUM63 on other metabolic parameters of interest. Following the collection and monitoring of data from the last follow-up medical visits planned in the protocol, the clinical database will be frozen for statistical analysis.
At the end of this process in accordance with Good Clinical Practices, Valbiotis confirms that the first results of the REVERSE-IT study will be available and communicated before the end of the first half of 2023. About TOTUM63 TOTUM63 is a unique and patented combination of 5 plant extracts that targets the pathophysiological mechanisms of type 2 diabetes. TOTUM63 has already been shown to be safe and effective in healthy patients in a Phase I/II clinical study.
Results from a randomized, placebo-controlled, international Phase II study showed that when compared to the placebo, TOTUM63 reduced fasting blood glucose and 2-hour blood glucose levels, two risk factors for type 2 diabetes. In these subjects, who were also abdominally obese, TOTUM63 also significantly reduced body weight and waist circumference. TOTUM63 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, Chili, India, South Korea and national phases are still underway in Brazil, Argentina, Canada, Thailand, Qatar, United Arab Emirates.
Production capacity for TOTUM63 has been validated in accordance with North American and European standards. TOTUM63 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 TOTUM63.
This unique partnership in the field of Health Nutrition foresees the marketing of TOTUM63 by Nestlé Health Science on a worldwide scale, possibly before obtaining a medical clearance depending on the area. They will also fund the final stages of development of TOTUM63.