Topline data from the study were published on 3 July 20191, which showed a significant reduction in hyperglycemia, body weight and waist size compared to placebo. The entire Phase IIA clinical study has therefore demonstrated the efficacy of VALEDIA® on various abnormalities in carbohydrate and lipid metabolism.
Professor Jean-Marie BARD, Hospital Practitionner and Professor of Fundamental and Clinical Biochemistry at the University of Nantes, scientific expert for the study, commented, “The full results clearly demonstrate a positive effect on the entire clinical profile: hyperglycemia, hypertriglyceridemia, hepatic steatosis, overweight and abdominal obesity, hypercholesterolemia and arterial hypertension. These risk factors, contribute to an increased risk of type 2 diabetes, cardiovascular disease and liver diseases such as NASH.”
Murielle CAZAUBIEL, Director of Development and Medical Affairs, and member of the VALBIOTIS Executive Board, explained, “Today, we are presenting very compelling data which demonstrates the global efficacy of TOTUM-63, active substance of VALEDIA® and its action on the metabolic profile as a whole. This is excellent news for our priority to reduce the risk of type 2 diabetes in prediabetic patients.
“We will soon be launching two concurrent Phase IIB studies in prediabetic patients (last studies), as announced previously. Our medium-term strategy is also clear: the significant lipid-lowering effect of VALEDIA® bodes extremely well for the reduction of non-alcoholic fatty liver, a risk condition for developing NASH. This will be the main focus of another Phase IIB clinical study. These results have opened up new opportunities for TOTUM-63 in the future, in the field of hypertension, for example.”
Additional results from the Phase IIA clinical study of VALEDIA® in lipid metabolism and arterial hypertension
The international Phase IIA clinical study evaluated the efficacy of VALEDIA® on carbohydrate and lipid metabolism. The subjects included presented with prediabetes, abdominal obesity and hypertriglyceridemia, which were not treated according to current guidelines, as well as a high fatty liver index and high blood pressure. Hypoglycemic, lipid-lowering or hypotensive treatments were excluded. Lipid and hypertension parameters were secondary criteria in the study.
This was a multicenter, randomized, placebo-controlled, double-blind study. Subjects received a daily dose of 5 grams of VALEDIA®, compared to 5 grams of placebo for subjects in the control group, over a 6-month period. Diet and physical activity levels remained the same throughout the study in both groups. Analyses were based on 51 subjects, 13 in the placebo group and 38 in the VALEDIA® group.
Additional analyses were conducted on a subgroup, involving all subjects at the beginning of the study with systolic blood pressure levels higher than 130 mmHg, the threshold for hypertension in cases of metabolic syndrome. The difference in the changes measured at the end of the study was significant (p <0.001) and reached 18.9 mmHg in favor of the VALEDIA® group (n = 18) compared to placebo (n = 8).
Sébastien PELTIER, CEO of VALBIOTIS concluded, “The additional results from this Phase IIA clinical study have far exceeded our expectations. This data demonstrates the efficacy of VALEDIA® for its primary indication, the reduction of risk of developing type 2 diabetes in people with prediabetes. What’s more, this study demonstrates the comprehensive action of VALEDIA® on metabolic syndrome. This is a major asset for VALBIOTIS, opening up new prospects in promising markets, such as in the field of non-alcoholic fatty liver or arterial hypertension, which will be a major focus point for future developments. In terms of our commercial strategy, these excellent results will naturally give new impetus to our negotiations with potential partners”.
Prediabetes is a growing public health problem worldwide, which is recognized by international organizations such as the WHO, the American Diabetes Association and the International Diabetes Federation, among others. Without effective treatment, 70% to 90% of prediabetic patients will develop type 2 diabetes.
VALEDIA® is the first clinically validated product specifically designed to help prediabetics reduce their risk of developing type 2 diabetes. VALEDIA® is the only product that contains the active ingredient TOTUM-63, a unique and patented combination of 5 plant extracts that act in synergy to target the physiopathological mechanisms of type 2 diabetes.
TOTUM-63 has already shown perfect tolerance and safety during a Phase I/II clinical study conducted in healthy volunteers. The results of the first international randomized, placebo-controlled study showed that in patients with prediabetes, TOTUM-63 reduces fasting blood glucose and blood glucose at 2 hours, two risk factors of type 2 diabetes. In these subjects, who also presented with hypertriglyceridemia and abdominal obesity, TOTUM-63 significantly reduced body weight, waist circumference, blood triglycerides, Fatty Liver Index, blood cholesterol levels, and arterial hypertension.
Source: Company Press Release