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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

2019

  • Announcement of a licensing agreement between GENFIT and Covance (LabCorp) to expand access to NIS4 in the clinical research field.
  • Protocol clearance by the FDA for Phase 2 Clinical Trial of elafibranor in Pediatric NASH.
  • Completion of the U.S IPO on Nasdaq, a major milestone for the company
  • FDA granting of Breakthrough Therapy Designation for elafibranor, based on Phase 2 data, for the treatment of PBC (Primary Biliary Cholangitis) in adults with inadequate response to UDCA.
  • Positive, 36-month safety review by the DSMB for RESOLVE-IT, the Phase 3 clinical trial evaluating elafibranor for the treatment of NASH.
  • Launch of a combination program of elafibranor and GLP-1 receptor agonist or an SGLT2 inhibitor – anti-diabetic drugs – to evaluate synergistic NASH therapies.
  • Launch of a Phase 2 clinical trial evaluating elafibranor’s activity on liver fat quantity and fat composition in nonalcoholic fatty liver disease (NAFLD)
  • Support and participation by GENFIT in the 2nd International NASH Day on June 12, organized in 2019 by the Global Liver Institute, after the success met by the 1st edition of International NASH Day
  • Announcement of a licensing and collaboration agreement with Terns Pharmaceuticals for the development and commercialization of elafibranor in Greater China for NASH and PBC.
  • FDA & EMA granting of Orphan Drug Designation for elafibranor for the treatment of PBC.

2018

  • Positive results of the phase 2 study evaluating elafibranor in PBC.
  • Launch of a US phase 2 proof-of-concept study with nitazoxanide (NTZ) in patients with NASH-induced fibrosis.
  • Positive outcome from the 30-month pre-planned safety review by the DSMB, in RESOLVE-IT phase 3 clinical trial with elafibranor.
  • Announcement of GENFIT’s plan to conduct registered public offering in the United States.
  • Positive outcome from the 24-month pre-planned safety review by the DSMB, in RESOLVE-IT phase 3 clinical trial with elafibranor.
  • Target reached for recruitment for the interim cohort analysis in the pivotal phase 3 RESOLVE-IT trial in NASH and fibrosis.
  • Launch of the NASH pediatric program, following PIP (Pediatric Investigation Plan) and PSP (Pediatric Study Plan) agreement by EMA (European Medicines Agency) and FDA (Food and Drug Administration).

2017

  • Significant contribution in the European LITMUS (Liver Investigation: Testing Marker Utility in Steatohepatitis) Initiative on NASH biomarkers.
  • Positive outcome from the 18-month pre-planned safety review by the DSMB, in RESOLVE-IT phase 3 clinical trial with elafibranor.
  • Completion of a €180 million offering of bonds convertible into new shares and / or exchangeable for existing shares (“OCEANEs”) due 2022.
  • Launch of the development phase of a new non-invasive In Vitro Diagnostic (IVD) test based on biomarkers aimed at identifying NASH patients eligible for treatment.
  • Approval of the change in mode of administration and management of the Company and nomination of the Chairman and CEO and the members of the Board of Directors at the General Shareholders’ Meeting.
  • First patient enrolled in a Phase 2 Trial recruiting adults with Primary Biliary Cholangitis (PBC).
  • Presentation during the International Liver Congress organized by EASL, of the repurposing program of nitazoxanide (NTZ), currently prescribed as an anti-parasitic agent, in several fibrosing diseases including liver fibrosis.

2016

  • 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.
  • Initiation of the first juvenile toxicity studies as part of the PIP (Pediatric Investigation Plan) of elafibranor in pediatric NAFLD/NASH, following the approval by EMA (European Medicines Agency).
  • Signature of an agreement between GENFIT and the Pinnacle Research Center (San Antonio, TX, USA), to support the launch of the NASH Registry Project, Database in which NAFLD patients are followed prospectively to gain information on co-morbidities historically linked to NAFLD/NASH, and after which GENFIT has access to anonymized patient data.
  • Fundraising for a total amount of €78,5 million, through private placement reserved to investors specialized in pharmaceutical/biotechnology (€33,9 million), followed by a capital increase with shareholders’ preferential subscription rights (€44,6 millions).
  • 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.
  • Identification of new RORγt inverse antagonists as candidates ready for regulatory pre-IND (Investigational New Drug) studies within the TGFTX1 program. These candidates are highly potent and selective against other members of the ROR nuclear receptor family, and interfere with IL-17 production in human blood leukocytes.
  • Launch of a large scale validation and qualification program of the non-invasive NASH diagnostic kit developed as part of the BMGFT03 program. First analyses confirm the predictive value of miRNAs identified by GENFIT as NASH biomarkers.
  • First patient is enrolled in the Phase III RESOLVE-IT clinical trial, intended to evaluate elafibranor as a treatment for NASH.
  • Fundraising for a total amount of €49,6 million through private placement mainly by institutional investors in the US.
  • Publication in the prestigious peer-reviewed Gastroenterology journal of the detailed results of the Phase IIb clinical trial evaluating elafibranor as a treatment for NASH.

2015

  • Design of the global phase 3 trial RESOLVE-IT to evaluate the benefits of Elafibranor treatment on NASH patients.
  • Design of 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.
  •  Approval of the international non-proprietary name (INN, or generic name) elafibranor for the drug candidate previously referred to as GFT505 by the The World Health Organization (WHO).
  • Elafibranor (GFT505), GENFIT’s lead pipeline product, completed a positive Phase 2b study in NASH.

2014

  • Celebration of GENFIT’s 15th birthday, marking a turning point in the achievement of its research goals.
  • 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.
 
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