Therapy Areas: Cardiovascular
Valbiotis concludes recruitment of Phase II HEART clinical study of TOTUM•070 for hypercholesterolemia
7 September 2021 -

Research and development company Valbiotis (FR0013254851 – ALVAL, PEA/SME eligible) said on Monday that it has completed the recruitment of 120 volunteers under its Phase II HEART clinical study with TOTUM•070 in schedule and in line with its development plan.

The French company added that the results of the With TOTUM•070 HEART study will be available in the second quarter of 2022.

This multicentre, international, randomized, placebo-controlled, double-blind HEART study involves 120 people with untreated moderate hypercholesterolemia between 130 and 190 mg/dL. The primary endpoint of the company's HEART study is the reduction of blood LDL-cholesterol levels, a risk factor for cardiovascular disease and in particular atherosclerosis and it has several secondary objectives of interest.

According to the company, TOTUM•070 is an innovative active substance derived from food plant extracts, without phytosterols or red yeast rice, developed to act on lipid metabolism in people with hypercholesterolemia. TOTUM•070 will be indicated for people with LDL-hypercholesterolemia for levels up to 190 mg/dL, with a moderate overall cardiovascular risk and no first-line drug treatment.

In France, Germany, Italy, Spain, UK and the US, about 174 million adults have elevated LDL-cholesterol levels. The market for the LDL-cholesterol lowering products is estimated at EUR1.2bn in these regions, including more than EUR600m in the US, concluded the company.