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BRIEF-Genfit announces pivotal phase 3 clinical trial of Elafibranor in NASH
November 16, 2015 / 6:43 AM / 2 years ago

BRIEF-Genfit announces pivotal phase 3 clinical trial of Elafibranor in NASH

Nov 16 (Reuters) - Genfit SA :

* Announces pivotal phase 3 clinical trial of Elafibranor in patients with NASH following regulatory input

* Initial approval to be based on analysis of first 900 patients, after 72 weeks treatment, based on a single histological surrogate endpoint

* Additional Golden 505 trial data presented at AASLD further demonstrate efficacy, cardiometabolic benefit, safety and good tolerability of Elafibranor

* Pivotal trial will be randomized, double-blind, placebo-controlled (2:1) phase 3 trial, conducted in approximately 1800 patients

* To support full approval, trial will continue in order to demonstrate impact of Elafibranoron the prevention of cirrhosis and other liver related outcomes Source text for Eikon: Further company coverage: (Gdynia Newsroom:)

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