Brief: Inventiva Says FDA Accepted Its IND Application For Phase II Combination Trial LEGEND

Inventiva SA

08/03/2022 07:19

March 8 (Reuters) - INVENTIVA SA  IVAA.PA :
    * FDA ASSESSMENT CONCLUDES THAT PHASE II COMBINATION TRIAL,
LEGEND, MAY PROCEED
    * INITIATION OF TRIAL IS PLANNED FOR H1 2022 AND PUBLICATION
OF
TOPLINE RESULTS IS EXPECTED FOR H2 2023
    * LEGEND IS EXPECTED TO RECRUIT A TOTAL OF 63 PATIENTS
NON-CIRRHOTIC NASH WITH T2D
    * PRIMARY EFFICACY ENDPOINT OF TRIAL IS A CHANGE IN
HEMOGLOBIN A1C
(HBA1C) AT END OF 24-WEEK TREATMENT COMPARED TO BASELINE
    * SECONDARY ENDPOINTS INCLUDE CHANGES IN LIVER ENZYMES,
GLYCAEMIC
AND LIPIDS PARAMETERS, INFLAMMATORY MARKERS AND BODY FAT
COMPOSITION
    * INVENTIVA ANNOUNCES THAT ITS IND APPLICATION FOR THE PHASE
II
COMBINATION TRIAL WITH LANIFIBRANOR AND EMPAGLIFLOZIN IN
PATIENTS WITH NASH AND T2D HAS BEEN ACCEPTED BY THE FDA

Source text for Eikon:  ID:nGNEbqHyNn 
Further company coverage:  IVAA.PA 

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