(BFM Bourse) – The neo-Aquitaine group specializes in the development of food supplements, where the marketing process is faster than for drugs, while carrying out trials to validate new health claims. The HEART trial having demonstrated an effect of Totum•070 on mild to moderate hypercholesterolemia, Valbiotis is looking for partners for future marketing.
Valbiotis is pleased with the clinical results of its compound “Totum•070”, but the market remains cautious, the stock falling 1.22% to 6.5 euros after the announcement. This product is a patented combination of plant extracts (the “totum” designates all the truly active molecules among the thousands of substances that make up a plant) intended to become not a drug against cholesterol, but a dietary supplement.
Remember that a product having an effect on health can be classified either among drugs (regulated by the ANSM in France) or food supplements (regulated by the DGCCRF), regardless of the nature of the product. The market for dietary supplements is currently experiencing considerable expansion, linked to a societal aspiration for more “naturalness” (many supplements actually being derived from plants) and the search for a better lifestyle emphasizing prevention. pathologies.
A “proprietary” health claim
Food supplements can benefit from health claims within a strict regulatory framework, but the vast majority are limited to “generic” claims (such as: “magnesium contributes to the normal functioning of the nervous system”, “vitamin E contributes to protect cells against oxidative stress”, etc.). Very few food supplements benefit from a “proprietary” health claim (unique to the product) issued by the authorities, in this case the EASA -European Food Safety Authority- for Europe and the FDA for the United States. .
Obtaining the right to report a specific claim is a rigorous process requiring the implementation of phase 1 and 2 clinical trials to the standards of the pharmaceutical industry and demonstrating in an “unequivocal” way the safety and the effectiveness of the product. The difference with drugs is that a phase 3 is not necessary, which greatly reduces development time and costs.
An effect that fades after six months
The phase 2 trial called HEART evaluated the efficacy of Totum•070 taken twice daily for six months in two times 60 volunteers with mild to moderate hypercholesterolemia not yet treated, in comparison with a placebo administered in a double-blind fashion. From 3 months of supplementation, Totum•070 significantly reduced blood levels of LDL cholesterol (-13% compared to placebo, with a p-value less than 0.01), and triglycerides (-14%, p-value less than 0.05), compared to placebo. The cholesterol-lowering effect persisted at 6 months but in an attenuated fashion (-9% blood LDL cholesterol relative to the placebo, p-value less than 0.015). The company no longer mentions an effect on triglycerides at 6 months.
For the scientific referent of the trial, Professor Jean-Marie Bard of the University Hospital of Nantes and the Institut de Cancérologie de l’Ouest, these data “validate the effectiveness of TOTUM•070 on blood LDL cholesterol, a factor well-known cardiovascular risk, and also demonstrate a lipid-lowering effect on triglycerides, associated with cardiovascular risk”. The practitioner also emphasizes that “the very good tolerance” of the active substance, an important issue for lipid-lowering strategies. “With these data, TOTUM•070 is therefore an excellent solution to make up for the lack of reliable options, suitable for mild to moderate hypercholesterolemia, for whom only lifestyle and dietary recommendations are currently offered”.
Towards a new study for Totum•070
From a regulatory point of view, Totum•070 is already marketable in Europe, after notification to the DGCCRF in France (mutual recognition applicable for the other countries of the European Union). Regulatory processes for North America and other geographies are ongoing. The company, which has already entered into a partnership with the giant Nestlé for another compound targeting the pre-diabetic state, will intensify its exchanges “with major players in health and nutrition” with a view to concluding a partnership with for ambition to market the product no later than the first half of 2024.
Totum•070 may be offered over the counter in pharmacies in the form of a capsule or a powder to be diluted. Accessible without a prescription, it may be recommended by health professionals.
“Given these positive results, the quality of the scientific data already obtained and the need for solutions for untreated patients, we have decided to market TOTUM•070 after these Phase II results. In this perspective, we are already engaged in the search for commercial partnerships with a marketing horizon no later than the first half of 2024. The scientific package of TOTUM•070 and our market studies with patients and healthcare professionals confirm this ambition”, declared Sébastien Peltier, the Chairman of the Management Board of Valbiotis. “At the same time, we will prepare a final Phase II/III clinical stage in order to obtain a health claim that will reinforce the value of this active substance”.
Guillaume Bayre – ©2022 BFM Bourse
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