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Find Clinical Drug Pipeline Developments & Deals by Valbiotis

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            Lead Product(s): TOTUM-854

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: TOTUM-854

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: University of Avignon

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 08, 2021

            Details:

            Preclinical results with the active substance TOTUM-854 on arterial hypertension, obtained through work undertaken as part of an academic partnership with Avignon University’s Laboratoire de Pharm-Ecologie Cardiovasculaire (LAPEC) as well as at the Riom R&D platform.

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            Lead Product(s): TOTUM-070

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: TOTUM-070

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 15, 2021

            Details:

            The main objective of this clinical study is to evaluate the efficacy of a 5g daily dose of TOTUM-070 and to confirm its safety. HEART results will support the application for a proprietary health claim related to the reduction of LDL-cholesterol.

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            Lead Product(s): TOTUM-070

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: TOTUM-070

            Highest Development Status: Phase II Product Type: Undisclosed

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 27, 2020

            Details:

            The clinical study HEART on TOTUM-070, a Phase II randomized placebo-controlled and double blind study, has just been initiated in accordance with the road map, the study protocol having been submitted to the French health authorities.

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            Lead Product(s): Totum-63

            Therapeutic Area: Endocrinology Product Name: Totum-63

            Highest Development Status: Phase II/ Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 21, 2020

            Details:

            EASD has selected the positive results of the international Phase II clinical study on TOTUM-63 in prediabetes to be presented next September in its 56th annual meeting. These results were selected by the American Diabetes Association last June 2020.

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            Lead Product(s): TOTUM-070

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: TOTUM-070

            Highest Development Status: Phase I/ Phase II Product Type: Undisclosed

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 14, 2020

            Details:

            TOTUM-070 is a combination of plant extracts that contains neither phytosterols nor red yeast rice, designed by VALBIOTIS’ proprietary R&D platform based in Riom (63).

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            Lead Product(s): Totum-63

            Therapeutic Area: Endocrinology Product Name: Totum-63

            Highest Development Status: Phase II/ Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 15, 2020

            Details:

            The 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.

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            Lead Product(s): TOTUM-070

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed

            Highest Development Status: Phase I/ Phase II Product Type: Undisclosed

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 16, 2020

            Details:

            VALBIOTIS expects to start a Phase II clinical trial evaluating the effect of TOTUM-070 in reducing LDL-cholesterol, in mild to moderate hypercholesterolemic patients.

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            Lead Product(s): TOTUM-63

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Undisclosed

            Partner/Sponsor/Collaborator: Nestle Health Sciences SA

            Deal Size: $67.1 million Upfront Cash: $5.1 million

            Deal Type: Partnership February 05, 2020

            Details:

            Partnership secures funding for the development and commercialization of TOTUM-63. Agreement also includes TOTUM-63 supply to Nestlé Health Science.