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

Regulatory News:

Valbiotis (FR0013254851 – ALVAL, PEA/PME eligible) (Paris:ALVAL), a commercially oriented Research and Development company committed to scientific innovation for preventing and combating metabolic and cardiovascular diseases, announces 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.

Sébastien PELTIER, co-founder and Chairman of the Valbiotis Executive Committee, comments: "I am extremely proud of the results of the REVERSE-IT study on TOTUM•63, which represent a major breakthrough in the fight against diabetes and its complications for people with prediabetes and untreated type 2 diabetes (early stage). We have provided unequivocal clinical evidence that TOTUM•63 is a promising solution for millions of people worldwide, helping to prevent the progression to type 2 diabetes. This is a groundbreaking and exciting moment for our company, and I would like to extend my warmest thanks to our employees, our partners including Nestlé Health Science, and especially to the patients who participated in this study. Together, we have accomplished something truly remarkable, and we are determined to continue our mission to develop innovative solutions to improve the health of people around the world. Beyond this great achievement, which opens up a new path, it is also a personal satisfaction, after almost 10 years of hard work."

Hans-Juergen WOERLE, Chief Scientific and Chief Medical Officer at Nestlé Health Science, comments: "We are thrilled with the completion of this large clinical study, gathering more than 600 patients, designed to rigorously evaluate TOTUM•63. This non-drug, plant-based active substance has the potential to significantly impact the management of early impairments of glucose metabolism."

Jean-Marie BARD, emeritus professor of biochemistry and hospital practitioner in pharmacy, scientific advisor of the REVERSE-IT study, President of the French Nutrition Society Scientific Committee, specifies: "With more than 600 patients included in more than 50 centers internationally, REVERSE-IT is one of the largest and most ambitious studies in the world with non-drug approaches to early dysglycemia, from prediabetes to the early stages of type 2 diabetes. The results of this study represent a significant breakthrough for these people with glycemic impairment and confirm the data already obtained in 2019 with the Phase II study, published in the journal Diabetes, Obesity and Metabolism in 2022. I am delighted to have participated in the clinical validation of this new approach. Many healthcare professionals will be able to provide a solution for their patients and change their clinical practices, which until now have been limited to lifestyle recommendations alone."