TOTUM-63 – Arterial hypertension

Arterial hypertension, the first cardiovascular risk factor

Arterial hypertension (AHT) is the world’s most prevalent chronic disease and the leading cause of premature death. It affects all countries, regardless of their level of development.

In the long term, AHT weakens the arteries and promotes the onset of serious diseases, predominantly heart attacks, strokes, peripheral arterial diseases and kidney failure. It is the primary cardiovascular risk factor in the world.

 

Sources: 2018 ESC/ESH Guidelines for the management of arterial hypertension; Prise en charge de l’hypertension artérielle de l’adulte, Recommandation de bonne pratique, HAS, 2016 www.has-sante.fr/jcms/c_2059286/fr/prise-en-charge-de-l-hypertension-arterielle-de-l-adulte

Key Figures

First chronic disease in the world

1.13

billion people worldwide with arterial hypertension in 2015. 30 to 45% of adults are hypertensive.

Source: 2018 ESC/ESH Guidelines for the management of arterial hypertension.

Hypertension thresholds

140

/90 mmHG, is the defined threshold for arterial hypertension in Europe. In the United States, the threshold value starts at 130/80 mmHg.

Sources: 2018 ESC/ESH Guidelines for the management of arterial hypertension; 2017 ACC/AHA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults.

TOTUM-63: a promising candidate in the fight against arterial hypertension, to prevent the risk of cardiovascular diseases

The Phase IIA clinical study of TOTUM-63 demonstrated the significant and positive effect of this active substance on blood pressure, versus placebo, particularly in hypertensive subjects. TOTUM-63 will therefore be developed for people with light to moderate AHT, an important risk factor for cardiovascular disease.

This is a new opportunity in a 1-billion people market, in which no non-pharmaceutical product with solid clinical evidence nor health claim for blood pressure reduction is yet available.

Clinical results

The Phase IIA clinical study in prediabetic subjects showed that TOTUM-63 significantly reduced systolic blood pressure (when the heart contracts) in the overall study population, versus placebo. Analysis of the findings demonstrated a greater decrease in subjects who had high blood pressure at the beginning of the study. TOTUM-63 significantly reduced systolic blood pressure, versus placebo:

  • by 10.6 mmHg, in the overall study population;
  • by 18.9 mmHg, in subjects with high systolic blood pressure at the beginning of the study (≥ 130 mmHg).

Details of this Phase IIA study are available on the Company’s corporate presentation, at the link below.

Safety and tolerance

The perfect tolerance and safety of TOTUM-63 were validated in a Phase I/II clinical study with healthy volunteers and were confirmed by the Phase IIA study with prediabetics. The results of the Phase I/II study were selected for presentation at the American Diabetes Association scientific sessions in June 2017.

Phase IIB clinical development pending

TOTUM-63 will be the subject of a specific Phase IIB clinical study to demonstrate its efficacy in a population with arterial hypertension who are at risk for cardiovascular disease. This study will be designed specifically to obtain a health claim in Europe and North America.

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