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About liver disease

Our History

In September 1999, GENFIT was created in northern France, at the heart of the Regional Hospital of Lille, in the Eurasanté business park. This major economic and scientific hub at the crossroads of Europe offers a unique position to forge collaborations with academic research institutions and pharmaceutical companies. GENFIT’s business activity was strengthened through the installation of GENFIT CORP. at Cambridge, Massachusetts, thus facilitating international contacts.

Key Events

2017

  • First patient enrolled in a Phase 2 Trial recruiting adults with Primary Biliary Cholangitis (PBC).
  • Launch of the next phase, for the development of a new non-invasive In Vitro Diagnostic (IVD) test based on biomarkers aimed at identifying NASH patients eligible for treatment.

2016

  • Detailed results of the Phase IIb clinical trial evaluating elafibranor as a treatment for NASH (administered orally in a single daily dose) were published in the prestigious Gastroenterology journal.
  • First patient is enrolled in the Phase III RESOLVE-IT clinical trial, intended to evaluate elafibranor as a treatment for NASH.
  • Authorization of the FDA to launch a Phase II clinical trial of elafibranor in a new indication – Primary Biliary Cholangitis (PBC), a rare disease with unmet need and only two orphan designated drugs approved to date.
  • Initiation of the first juvenile toxicity studies of the Pediatric Investigation Plan (PIP) of elafibranor in NASH, following the favorable opinion of the European Medicines Agency (EMA).
  • Launch of The NASH Education Program™, endowment fund created at GENFIT’s initiative dedicated to the development and funding of disease awareness activities targeting the medical field and general public.

2015

  • In March, elafibranor (GFT505), GENFIT’s lead pipeline product, completed a positive Phase 2b study in NASH.
  • In June, the World Health Organization (WHO) approved the international non-proprietary name (INN, or generic name) elafibranor for the drug candidate previously referred to as GFT505.
  • In September, GENFIT announces that it has designed a diagnostic tool based on algorithms including a new type of NASH biomarkers: small non-coding RNAs or miRNAs. It should allow – without invasive liver biopsy – to identify NASH patients that should be treated with Elafibranor or other appropriate treatment.
  • In November 2015, GENFIT announced the design of the global phase 3 trial RESOLVE-IT to evaluate the benefits of Elafibranor treatment on NASH patients.

2014

  • In September, GENFIT celebrated its 15th birthday, marking a turning point in the achievement of its research goals.
  • On April 17, 2014 GENFIT is listed on the Euronext Paris regulated market – Compartment B (GNFT)

2010 – 2013

GENFIT positions itself as a pioneer in the discovery of therapeutic solutions for NASH.

  • Elafibranor, drug candidate among the most advanced in its therapeutic area, enters Phase 2b for the treatment of NASH.
  • GENFIT and Sanofi extend 10 years of collaboration with a new risk-sharing partnership.

2006 – 2009

GENFIT continues its growth and accelerates the development of its drug candidates.

  • GENFIT is listed on the Alternext market of NYSE Euronext Paris (ALGFT).
  • Clinical data confirm the safety and the therapeutic potential of elafibranor (GFT505) in diabetes complications.

2003 – 2005

GENFIT finances its own programs of drug discovery, and very rapidly the first proprietary drug candidates enter preclinical and clinical trials.

1999 – 2002

Since its inception, GENFIT collaborates with many players in the pharmaceutical world for our expertise in gene regulation and functional genomics.

  • Creation of Genfit and installation in modern laboratories in Lille, France.
  • Research alliances with Sanofi Aventis , Merck, UCB Pharma, Solvay / Abbott, Pierre Fabre, Kowa.