- New preclinical results indicate that elafibranor has anti-tumor development activity in the context of NAFLD/NASH-induced hepatocellular carcinoma (HCC).
- Strong involvement in the 1st International NASH Day as key supporter and benefactor.
- 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).
- 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).
- 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.
- 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.
- First patient is enrolled in the Phase III RESOLVE-IT clinical trial, intended to evaluate elafibranor as a treatment for NASH.
- 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.
- 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.
- 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
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.