Valbiotis SA announced the success of the REVERSE-IT Phase II/III clinical study on TOTUM-63, involving 636 prediabetic and untreated type 2 diabetic patients. The study, which was international, multicentric, randomized, and placebo-controlled, confirmed the efficacy of TOTUM-63 in reducing fasting blood glucose at 2 and 3 intakes per day. This success has led to a CHF 4 million lump sum payment from Nestlé Health Science, as per their global strategic partnership agreement signed in February 2020.
The REVERSE-IT study included participants with impaired glucose metabolism, ranging from prediabetes to untreated type 2 diabetes. Participants were divided into three arms, with the intervention arm receiving TOTUM-63 at a dose of 5 g/day in three daily intakes. The study met its objectives on the primary endpoint, fasting blood glucose, with significant results compared to placebo.
TOTUM-63 is a patented combination of 5 plant extracts targeting the pathophysiological mechanisms of type 2 diabetes. It has intellectual property validated by patents in major markets worldwide. The partnership with Nestlé Health Science aims for the global commercialization of TOTUM-63, with production capacity validated according to North American and European standards. The comprehensive results of the study will be communicated in a subsequent press release and submitted for presentation at international congresses and publication in peer-reviewed journals.
