“The REVERSE-IT study results from the combined expertise of
VALBIOTIS and Nestlé Health Science. We have strong ambitions for
this last regulatory clinical phase, that are based on the very good
results we obtained in the previous Phase II clinical trial. Considering
the resources we mobilize, we can reasonably expect the topline data
to be released before mid-2022. We feel enthusiastic for this final
step of our innovative R&D process and we are confident in the fact
that it will get TOTUM-63 to wide and successful commercialization,
which may take place before obtaining health claims.”
“The scope and conditions of this clinical trial are significant: it is
being led in 30 international clinical settings with 600 participants.
The thoroughness of this trial will provide results that are extremely
useful in demonstrating a safe and effective opportunity to help
patients who have prediabetes and Type 2 Diabetes.”
The REVERSE-IT trial will be randomized and placebo-controlled, with the same primary objective
(reduction in fasting glycemia), the same duration of supplementation (6 months) and the same tested
dose (5g/day) and regimen (three times per day) than the previous Phase II study, which positive
results were published in 2019 (Press releases, 3rd July 2019 and 2nd September 2019).
The study population will include 600 subjects with abnormally elevated fasting blood glucose
(dysglycemia) and abdominal obesity, two frequently associated conditions. The number of subjects
included will guarantee the robustness of this pivotal trial.
Led in a wider population, this trial will also pursue larger clinical objectives, with a three-arm design.
The regimen of three doses per day, for a total daily dose of 5g, will be tested against placebo
(200 subjects receiving TOTUM-63 in one arm and 200 subjects receiving a placebo in the second
arm). The primary criterion is the reduction in fasting blood glucose against placebo, with this three
doses per day regimen. A third open label arm will test a regimen of two doses per day, for the same
total daily dose of 5g, on 200 subjects.
The trial will evaluate several other metabolic criteria of high interest for people with prediabetes or
early stage untreated Type 2 Diabetes.
The partnership with Nestlé Health Science also plans an adjunct clinical study to obtain exploratory
data on TOTUM-63 mode of action in humans.
VALBIOTIS will provide details on its other products in a subsequent communication.
Murielle CAZAUBIEL,
Head of Development & Medical Affairs of VALBIOTIS
Hans-Juergen WOERLE,
Chief Scientific & Medical Officer of Nestlé Health Science
Groet,,poil