VALBIOTIS is set to initiate a Phase II HEART clinical study of TOTUM-070 for the reduction of blood LDL-cholesterol levels in untreated mild to moderate LDL-hypercholesterolemia patients.
Derived from food plant extracts, TOTUM-070 is an innovative active substance free of phytosterols and red rice yeast and can work on lipid metabolism in hypercholesterolemic individuals.
The latest development comes after the company received a positive opinion from the CPP (French ethic committee) and authorisation from the ANSM (French National Agency for the Safety of Medicines and Health Products).
The randomised, double-blind, placebo-controlled clinical study will enrol 120 participants with untreated moderate hypercholesterolemia between 130mg/dL and 190mg/dL.
Subjects will be divided into two equivalent arms of 60 subjects, supplemented for six months with TOTUM-070 or placebo.
The study’s main objective is to analyse the efficacy of a 5g daily dose of TOTUM-070 and to confirm its safety. The reduction in blood LDL-cholesterol levels will form the study’s primary endpoint, along with several secondary objectives.
It will be carried out under the scientific expertise of the University Hospital professor and hospital practitioner Nantes Jean-Marie Bard.
Results from the study, expected next year, will back the application for a proprietary health claim linked to the reduction of LDL-cholesterol, a cardiovascular risk factor.
VALBIOTIS Development and Medical Affairs head, Management Board member Murielle Cazaubiel said: “VALBIOTIS is very proud to bring its second active substance, TOTUM-070, to the Phase II clinical stage.
“The design of the HEART study will provide unequivocal proof of the efficacy of this active substance in hypercholesterolemic patients.”
The company noted that it intends to conclude a partnership and license agreement with an international healthcare player for marketing TOTUM-070.
Last February, VALBIOTIS signed a strategic partnership with Nestlé Health Science for the active substance TOTUM-63, aimed at reducing the risk of type 2 diabetes in prediabetic people.