Valbiotis announces approval to launch the two Phase II/III INSIGHT and INSIGHT 2 clinical studies, the last step in the development of TOTUM•854 for the reduction of blood pressure.
Valbiotis, a Research and Development company committed to scientific innovation for preventing and combating metabolic diseases, announces that it has received approval to launch the two international multicenter Phase II/III INSIGHT and INSIGHT 2 clinical studies on TOTUM•854, for the reduction of blood pressure. These two trials will include 800 volunteers with mild to moderate elevated blood pressure, a risk factor for cardiovascular diseases, with 400 volunteers in each study. The authorizations received enable the launch of clinical recruitment, scheduled to be completed in the first half of 2023.
The INSIGHT Phase II/III international, multicenter, randomized, placebo-controlled clinical study will be conducted on a population of 400 volunteers with mild to moderate elevated blood pressure (systolic blood pressure between 130 mmHg and 159 mmHg and diastolic blood pressure < 100 mmHg). It will include two groups: a TOTUM•854 group with a dose of 3.7 g/day and a placebo group. The primary endpoint will be a reduction in systolic blood pressure, after 3 months of supplementation, between the TOTUM•854 group and the placebo group. In addition, 24-hour ambulatory blood pressure measurement will be performed and will be one of the secondary endpoints of the study.
The INSIGHT 2 clinical study, also international, multicenter, randomized and placebo-controlled, will be carried out on 400 other subjects with the same inclusion criteria. There will be two groups: a TOTUM•854 group receiving a reduced dose (2.6 g/day) and a placebo group. The primary endpoint will be a reduction in systolic blood pressure, after 3 months of supplementation, between the TOTUM•854 group and the placebo group.
In addition to these clinical efficacy studies, the development plan for TOTUM•854 includes a bioavailability and mode of action study in 10 volunteers to characterize TOTUM•854 metabolites and identify their effects on human cell lines. The results are expected by the end of 2022.
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