VALBIOTIS Announces the First Patient First Visit in the International Phase II/III REVERSE-IT Clinical Study on TOTUM-63 to Reduce Type 2 Diabetes Risk Factors

Nachrichtenquelle: Business Wire (engl.)
15.07.2020, 17:40  |  144   |   |   

Regulatory News:

VALBIOTIS (Paris:ALVAL) (FR0013254851 - ALVAL, PEA/SME eligible) a Research & Development company committed to scientific innovation for preventing and combating metabolic diseases, announces the First Patient First Visit in the international Phase II/III REVERSE-IT clinical study designed to assess TOTUM-63 for the reduction of Type 2 Diabetes metabolic risk factors.

Murielle CAZAUBIEL, member of the Management Board and Director of Development and Medical Affairs at VALBIOTIS, comments: "The first visit of this first subject, a few days after obtaining both ANSM1 approval and the favorable decision from the CPP2, marks the concrete launch of the REVERSE-IT study, the results of which are expected in mid-2022. We are right on schedule and are delighted to be able to enter the operational phase of this major study so quickly. We also welcome the enthusiasm and commitment of all the partner investigation centers."

Dr Hans-Juergen WOERLE, Chief Scientific and Medical Officer at Nestlé Health Science, states: "The first visit of the first subject in the Phase II/III study is a great step forward for TOTUM-63 and encouraging news for patients with prediabetes or untreated early stage Type 2 diabetes. With the 600 patients in this global clinical study, the objective is to demonstrate efficacy and safety of a new plant-based extract.“

The pivotal, randomized, double-blind, placebo-controlled REVERSE-IT study will include 600 patients with fasting hyperglycemia ranging from prediabetes to untreated early stage Type 2 Diabetes. The study should confirm the efficacy of TOTUM-63 - at a dose of 5g/day for 6 months - in addressing the metabolic risk factors for developing Type 2 Diabetes, compared to placebo. The protocol will assess the effect of TOTUM-63 on fasting blood glucose, the primary endpoint of the study, as well as on two-hour blood glucose and anthropometric parameters (body weight, waist circumference and body fat mass), all well-known risk factors for Type 2 diabetes.

REVERSE-IT is being conducted in more than 30 centers in France and internationally.

As a result of this achievement, VALBIOTIS will receive the first milestone payment of CHF 3 million from Nestlé Health Science. The global strategic partnership with Nestlé Health Science, concluded in February 2020, includes an upfront payment of CHF 5 million, already received by Valbiotis, development & sales milestone payments up to a maximum CHF 66 million and tiered royalties on net sales. The agreement also includes the supply of TOTUM-63 by VALBIOTIS to Nestlé Health Science, representing an additional source of revenue.

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