Brief: GENFIT Announces Trial of Elafibranor Did Not Show Significant Effect On NASH Patients

Genfit SA

12/05/2020 10:39

May 12 (Reuters) - GENFIT SA  GNFT.PA :
    
    * ANNOUNCED ON MONDAY INTERIM ANALYSIS OF RESOLVE-IT PHASE 3
TRIAL
OF ELAFIBRANOR DID NOT DEMONSTRATE SIGNIFICANT EFFECT ON PRIMARY
ENDPOINT OF NASH RESOLUTION WITHOUT WORSENING OF FIBROSIS
    * RESPONSE RATE IN THE 717 PATIENTS ENROLLED ON STUDY DRUG
WAS
19.2% FOR PATIENTS WHO RECEIVED ELAFIBRANOR 120MG COMPARED TO
14.7% FOR PATIENTS IN THE PLACEBO ARM
    * ON THE FIBROSIS KEY SECONDARY ENDPOINT, 24.5% OF PATIENTS
WHO
RECEIVED ELAFIBRANOR 120MG ACHIEVED FIBROSIS IMPROVEMENT OF AT
LEAST ONE STAGE COMPARED TO 22.4% IN THE PLACEBO ARM
    * THE OTHER KEY SECONDARY ENDPOINT RELATED TO METABOLIC
PARAMETERS
DID NOT ACHIEVE STATISTICAL SIGNIFICANCE 
    * SAFETY AND TOLERABILITY OF ELAFIBRANOR WAS CONSISTENT WITH
PREVIOUSLY CONDUCTED STUDIES
    * WE PLAN TO SHARE THESE DETAILED FINDINGS WITH THE
REGULATORY
AUTHORITIES IN THE COMING MONTHS AND, WITH THEIR GUIDANCE,
DETERMINE A FINAL DECISION REGARDING THE CONTINUATION OF THE
RESOLVE-IT TRIAl - CEO
    * WILL ENGAGE WITH REGULATORY AUTHORITIES TO DETERMINE NEXT
STEPS
REGARDING THE EXTENSION PHASE EVALUATING THE EFFECT OF
ELAFIBRANOR ON CLINICAL OUTCOMES
    * WILL PROVIDE UPDATED GUIDANCE ON ITS GLOBAL CORPORATE
STRATEGY
LATER IN THE YEAR
    * WILL CONTINUE AS PLANNED WITH NIS4TM AND PHASE 3 PBC
PROGRAMS

    
 Source text for Eikon:  ID:nGNE5T0lS1 
    
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