May 12, 2020 / 9:40 AM / 19 days ago

BRIEF-GENFIT Announces Trial of Elafibranor Did Not Show Significant Effect On NASH Patients

May 12 (Reuters) - GENFIT SA:

* 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

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