Brief: Genfit To Present New Clinical Data On Investigational Compound Elafibranor

Genfit SA

03/11/2021 09:14

Nov 3 (Reuters) - GENFIT SA  GNFT.PA :
    * ANNOUNCED ON TUESDAY THAT CLINICAL DATA ON GENFIT’S
INVESTIGATIONAL COMPOUND ELAFIBRANOR TO BE PRESENTED AT AASLD
THE LIVER MEETING
    * DATA COMES FOLLOWING THE COMPLETION OF A PHASE 1
OPEN-LABEL,
NON-RANDOMIZED, PARALLEL-GROUP TRIAL
    * OBJECTIVES WERE TO ASSESS PHARMACOKINETICS, SAFETY AND
TOLERABILITY OF ELAFIBRANOR IN HEPATIC IMPAIRED PATIENTS AND TO
INFORM THE POTENTIAL NEED FOR DOSE ADJUSTMENT IN PATIENTS WITH
HEPATIC IMPAIRMENT
    * 20 SUBJECTS WITH HEPATIC IMPAIRMENT AND 10 HEALTHY
VOLUNTEERS
WITH NORMAL HEPATIC FUNCTION WERE GIVEN A SINGLE ORAL DOSE OF
ELAFIBRANOR 120MG
    * ELAFIBRANOR WAS GENERALLY SAFE AND WELL TOLERATED IN THIS
STUDY
    * PHARMACOKINETIC DATA SUGGEST THAT TOTAL DRUG EXPOSURE OF
ELAFIBRANOR AND ITS ACTIVE METABOLITE ARE NOT SIGNIFICANTLY
ALTERED IN HEPATIC IMPAIRED PATIENTS
    * INCREASES IN UNBOUND DRUG IN SEVERE HEPATIC IMPAIRMENT ARE
NOT
ANTICIPATED TO BE CLINICALLY MEANINGFUL
    * ELAFIBRANOR DOSE ADJUSTMENT IS NOT LIKELY TO BE REQUIRED
FOR
PATIENTS WITH HEPATIC IMPAIRMENT

Source text for Eikon:  ID:nGNE2fGkB 
Further company coverage:  GNFT.PA 

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