Pre-diabetes is an increasingly common public health problem that has been recognized by international organizations such as the World Health Organization, the American Diabetes Association, and the International Diabetes Federation. If not effectively treated, 70%-90% of pre-diabetes patients will develop type 2 diabetes. Valedia is the first product that was clinically proven to reduce the risk of developing type 2 diabetes in pre-diabetic patients. The active pharmaceutical ingredient in Valedia is TOTUM-63, a unique combination of five plant extracts with up to 63 bioactive molecules, synergistically targeting five key metabolic organs (liver, pancreas, intestine, muscle, adipose tissue) and physiological and pathological mechanisms of type 2 diabetes. In clinical research, TOTUM-63 is a natural product that exhibits perfect tolerance and safety.
Recently, the biotech company Valbiotis published additional positive results for four parameters in a secondary endpoint of a Phase IIa clinical study evaluating Valedia (active ingredient: TOTUM-63) in patients with pre-diabetes.
Figure 1 Results of Valedia in the Phase IIa Clinical Study of Prediabetes Patients (Valbiotis Corporate presentation 2019)
Previously published top line results (July 3, 2019) showed that Valedia significantly reduced blood glucose levels and body weight compared with placebo. The additional secondary endpoints presented this time showed that compared with placebo, Valedia significantly reduced blood triglyceride levels by 32.2%, fatty liver index (liver fat accumulation) by 18.7%, and blood low-density lipoprotein cholesterol (LDL-C) levels by 11.7%. Arterial hypertension was significantly reduced by 10.6 mm Hg (significantly reduced 18.9 mm Hg in hypertensive patients). Based on the above results, Valedia became the first clinical proven product to effectively reduce multiple risk factors and various abnormalities such as carbohydrates and lipid metabolism and arterial hypertension in pre-diabetes patients. The results of phase IIa studies have exceeded all expectations. Valedia’s overall efficacy for subjects at risk for metabolic disease has been confirmed.
The multicenter, randomized, double-blind, placebo-controlled study conducted in pre-diabetic patients in Europe assessed the efficacy and safety of Valedia versus placebo. Specifically, each subject received 5 grams of Valedia daily, and patients in control group received 5 grams of placebo daily for 6 months. During the study period, the dietary habits and physical activity levels of the two groups remained unchanged. The results showed that Valedia significantly reduced fasting and postprandial blood glucose levels in this cohort compared with placebo, which is the two major risk factors for type 2 diabetes and the primary and secondary endpoint of the study. Valedia also significantly reduced body weight and waist circumference compared to placebo.
Based on the data from this study, Valbiotis has initiated the last two phase IIb clinical studies (REVERSE-IT and PREVENT-IT). Because moderate fasting hyperglycemia is a major risk factor for type 2 diabetes in pre-diabetes patients, the primary endpoints of these two studies were set to fasting blood glucose levels, and data will be used to support health claims for lowering the risk of type 2 diabetes in Valedia in Europe and North America. This regulatory process does not require a phase III study. Valedia’s commercialization plan will be carried out in 2021.
References:
1.Valbiotis Corporate presentation – July 2019
2.VALBIOTIS Announces Additional Positive Results From the Phase IIA Clinical Study of VALEDIA?, the First Product Proven Effective in People With Prediabetes, in Lipid Metabolism and Arterial Hypertension