The Phase II HEART clinical study conducted by Valbiotis, a company dedicated to combating metabolic diseases, has achieved its primary objective of significantly reducing blood LDL cholesterol levels using TOTUM-070. This multicentric, randomized, placebo-controlled, double-blind study involved 120 volunteers with untreated mild to moderate hypercholesterolemia. Participants were given a daily dose of 5 g of TOTUM-070 or a placebo for six months.
After three months, TOTUM-070 significantly reduced LDL cholesterol by 13% and triglycerides by 14% compared to the placebo. By the end of the six-month period, the reduction in LDL cholesterol was 9% compared to the placebo. These results indicate that TOTUM-070 is a clinically proven, well-tolerated non-drug option for managing hypercholesterolemia, complementing lifestyle and dietary recommendations.
Sébastien Peltier, Chairman of the Board of Directors at Valbiotis, expressed that the clinical success exceeded expectations, highlighting the significant reduction in LDL cholesterol and triglycerides. The company plans to market TOTUM-070 by the first half of 2024, following these Phase II results, and is seeking commercial partnerships. Additionally, Valbiotis is preparing for a final Phase II/III clinical step to obtain a health claim for TOTUM-070.
The study also confirmed the safety and tolerance of TOTUM-070, with comprehensive data to be presented at international scientific conferences. Prof. Jean-Marie Bard, a scientific advisor for the HEART study, emphasized the efficacy of TOTUM-070 in reducing LDL cholesterol and its lipid-lowering effect on triglycerides, alongside its good tolerance. Murielle Cazaubiel, Head of Development at Valbiotis, noted the achievement of demonstrating the relevance of a plant-based active substance in a demanding clinical field.
TOTUM-070's mode of action involves reducing cholesterol absorption at the intestinal level and decreasing de novo cholesterol synthesis at the hepatic level, with additional liver benefits observed. The product will be available in two forms (capsules or powder for dilution) and can be marketed in Europe, with regulatory processes ongoing for North America and other regions.
Hypercholesterolemia, a significant cardiovascular risk factor, affects a large portion of the global population, with a notable prevalence in Europe and North America. The success of TOTUM-070 offers a promising solution for patients with mild to moderate hypercholesterolemia, addressing the need for effective, well-tolerated intermediary solutions between lifestyle changes and long-term drug treatments.
