TOTUM•854 is a unique patented combination of plant extracts, specifically designed to reduce arterial blood pressure in people with mild to moderate elevated blood pressure, a risk factor for cardiovascular disease.
Overview
Arterial hypertension, the leading cardiovascular risk factor in the world
Arterial hypertension (AHT) is the world’s most prevalent chronic disease and the leading cause of premature death. It affects all countries, whether rich or poor. Over time, 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:
– ESC/ESH Guidelines for the management of arterial hypertension, European Heart Journal, 2018;
– 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
1.13 billion people worldwide suffered from arterial hypertension in 2015. 30% to 45% of adults were hypertensive.
Source: 2018 ESC/ESH Guidelines for the Management of Arterial Hypertension.
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.
Active substance
TOTUM•854 is a unique patented combination of plant extracts, designed to reduce blood pressure in people with low to moderate elevated blood pressure, a risk factor for cardiovascular diseases.
TOTUM•854 could provide a new opportunity on a global market of more than one billion people, as no non-drug product has shown solid clinical evidence to date or received a health claim authorization relative to the reduction of blood pressure.
Illustrative purpose only – product not marketed
Preclinical results
Led in two different in vivo models, predictive of human physiology, the preclinical studies showed that TOTUM•854 prevented arterial hypertension. These preclincal data were obtained thanks to a partnership with the experimental unit of the Cardiovascular Pharm-Ecology Lab (LaPEC) of Avignon University.
They were presented in April 2021 at the Annual Joint Meeting of European Society of Hypertension (ESH) and International Hypertension Society (ISH).
Hypertension model induced by L-NAME (NO synthase inhibitor)
In this classic model of hypertension, TOTUM•854 prevented the onset of hypertension, over 3 weeks, compared to L-NAME only. This significant preventive was shown on:
– the raise of dystolic blood pressure (SBP);
– the raise of diastolic blood pressure (DBP).
Polygenic hypertension model (SHR, Spontaneous Hypertensive Rat)
In this model of spontaneous hypertension, TOTUM•854 showed a positive effect, delaying the onset of arterial hypertension. An acute effect was also recorder after and oral intake of one dose of TOTUM•854.
Clinical development
The TOTUM•854 clinical development program includes three clinical studies, whose results will be required in Europe and the United States for health claim applications in the reduction of blood pressure, which is a risk factor for cardiovascular disease:
- 2 Phase II/III international and multicentric clinical studies, randomized, placebo-controlled and double-blind: INSIGHT and INSIGHT 2. These simultaneous studies will include 400 subjects each (800 in total) with low to moderate elevated blood pressure and will test two TOTUM•854 doses (3.7 g/day in INSIGHT, 2.6 g/day for INSIGHT 2). Their primary endpoint will be the reduction of systolic blood pressure. Recruitment is ongoing and should be completed in the first semester of 2023.
- A MoA and bioavailability clinical study, to identify all TOTUM•854 metabolites and their effect on human cellular models, in 10 volunteers. Results are expected at Q4 2022.
Intellectual property
Valbiotis has adopted a global strategy to protect its intellectual property: patent applications have been filed for TOTUM•854 in 61 countries, including key markets: Europe, USA, Canada, China, Russia, Japan, Brazil and Australia.
Patents have already been issued in 48 countries, including in the USA, Europe (39 countries), China and Russia, providing a very high level of protection.