Valbiotis SA presented additional positive results from the Phase II HEART clinical study with TOTUM•070 for hypercholesterolemia. In the commercially targeted population with cholesterol levels above 130 mg/dl at randomization, TOTUM•070 reduced blood LDL cholesterol levels by 13.7% at 3 months and by 14.3% at 6 months, compared to placebo, with a very high response rate. In parallel, Valbiotis has obtained new data confirming the intestinal and hepatic mode of action of this active substance, in preclinical and human studies, which will be presented at the next American Heart Association Annual Meeting.

With this solid clinical and scientific package for TOTUM•070, backed up by market studies, the Company has validated its objective of commercialization by the first half of 2024 at the latest and is intensifying its exchanges with major players in the health and nutrition sectors. Additional positive results from the HEART clinical study in the final target population: The Phase II HEART clinical study was a multi-center, international, randomized, placebo-controlled, double-blind study involving 120 people with untreated mild to moderate LDL hypercholesterolemia. The participants were divided into 2 equivalent arms of 60 people, supplemented for 6 months with a daily dose of 5 g of TOTUM•070 or a placebo, in two intakes.

The first positive results were announced on June 13, 2022. Of the 120 volunteers included in the study, 84 had blood LDL cholesterol levels greater than 130 mg/dl at randomization, which is the commercially targeted population for TOTUM•070. In this population, TOTUM•070 showed increased efficacy on blood LDL cholesterol levels, with a 13.7% reduction obtained at 3 months and 14.3% at 6 months compared to placebo.

Blood triglyceride levels were reduced by 14.3% at 3 months and 14.4% at 6 months, compared to placebo. Also in this population, the data show a very high response rate, with 92.5% of volunteers responding at 3 months. This rate even reached 100% when the cholesterol level at inclusion exceeded 160 mg/dl.

Furthermore, in the overall study population, stratified analysis showed that the magnitude of the reduction in blood LDL cholesterol was significantly correlated with the level of LDL cholesterol at baseline: TOTUM•070 was more effective the higher the initial cholesterol level. New data on the multi-targeted intestinal and hepatic mode of action of TOTUM•070 selected by the American Heart Association Annual Meeting: Following the first mode of action data already published, extensive preclinical work explored the specific action of TOTUM•070 at the intestinal level. This work first demonstrated effects on the abundance and diversity of the intestinal microbiota, as well as on bacteria known to be involved in the regulation of metabolism, which could help explain the effects of TOTUM•070.

Other studies have also confirmed and documented the effect of TOTUM•070 on intestinal cholesterol absorption, one of the main levers of action on hypercholesterolemia. They will be presented at the next annual meeting of the American Heart Association in November 2022. At the hepatic level, the clinical mode of action study, which had previously reported positive results, has delivered additional results at the molecular level2.

RNA sequencing analyses demonstrate that TOTUM•070 metabolites modulate a large number of genes involved in the regulation of cholesterol, fatty acid and lipoprotein metabolism in human liver cells. These molecular data confirm the effect of TOTUM•070 on human liver cells and provide additional information on the hepatic mechanisms of action of TOTUM•070. These additional results will also be presented at the AHA meeting in November 2022.