GENFIT: Presentations at EASL/ILC 2016 Highlight Progress in NASH Treatment, Biomarker Diagnostics, and Programs Targeting Fibrotic Diseases
Lille (France), Cambridge (Massachusetts, United States), March 30, 2016 – GENFIT (Euronext: GNFT – ISIN: FR0004163111), a biopharmaceutical company at the forefront of developing therapeutic and diagnostic solutions in metabolic and inflammatory diseases, that notably affect the liver or the gastrointestinal system, today announced it will present data at the International Liver Congress (ILC), the annual meeting of the European Association for the Study of the Liver (EASL), April 13-17 in Barcelona, Spain.
Presentations at the meeting will highlight: Elafibranor’s efficacy and its beneficial effect on cardiometabolic risk factors in the treatment of NASH as evidenced in the Phase IIb trial; non-invasive biomarkers for NASH diagnosis; and new compounds with potential for treating fibrotic diseases.
Specific presentations include:
2 oral presentations
› Thursday 14th, 5:30pm – 5:45pm
PNPLA3 STATUS IN NASH IS ASSOCIATED WITH INCREASED HISTOLOGICAL SEVERITY AT BASELINE BUT NOT WITH RESPONSE TO THERAPY IN THE GOLDEN-505 ELAFIBRANOR TRIAL – Vlad Ratziu et al. (PS023)
› Saturday 16th, 1pm – 1:15pm
A POST-HOC ANALYSIS OF THE GOLDEN505 TRIAL DEMONSTRATES HISTOLOGICAL AND CARDIOMETABOLIC EFFICACY OF ELAFIBRANOR-120 MG IN PATIENTS WITH MODERATE OR SEVERE NASH THAT ARE ELIGIBLE FOR PHARMACOTHERAPY – Vlad Ratziu et al. (PS111)
› Friday 15th, 8am – 6pm
RELATIONSHIP BETWEEN BASELINE HEPATIC DISEASE SEVERITY AND THE CARDIOMETABOLIC AND ANTIINFLAMMATORY EFFECTS OF ELAFIBRANOR IN PATIENTS WITH NASH Sven Francque et al. (FRI-339)
› Friday 15th, 8am – 6pm
RORγT INHIBITION IN THE LIVER PREVENTS HEPATIC FIBROSIS PROGRESSION, A PROOF OF CONCEPT STUDY WITH A POTENT, FIRST IN CLASS, HEPATOCENTRIC RORγT INVERSE AGONIST – Zouher Majd et al. (FRI-253)
› Saturday 16th, 8am – 6pm
THE IDENTIFICATION OF NOVEL SMALL MOLECULE COMPOUNDS WITH POTENT ANTIFIBROTIC PROPERTIES BY PHENOTYPIC SCREENING ON PRIMARY HUMAN STELLATE CELLS – Carole Belanger et al. (SAT-418)
› Saturday 16th, 8am – 6pm
A NEW METHOD INCLUDING THE QUANTIFICATION OF CIRCULATING MIRNAS ALLOWS THE EFFICIENT IDENTIFICATION OF NASH PATIENTS AT RISK WHO SHOULD BE TREATED – Arun Sanyal et al. (SAT-431)
Satellite Symposium on Thursday, April 14th (7:30am)
“NASH: Optimizing therapy for progressive disease”, Hall 8.0, Room B2, with Professors Vlad Ratziu, MD, PhD (Chair), Stephen A. Harrison, MD, and Sven Francque, MD, PhD
Investigator Meeting on Thursday, April 14th
“Challenges and Opportunities of Elafibranor Phase 3 Trial RESOLVE-IT” to present the key aspects of the RESOLVE-IT protocol
› Sophie Mégnien (CMO) will co-chair a working group of the Liver Forum which aims to optimize drug development for the treatment of NASH patients in collaboration with regulators, scientific organizations, academic and industry stakeholders,
› GENFIT will host a booth (#2900 E) in the exhibitor hall.
For more information please visit the EASL annual meeting website:
About Elafibranor: Elafibranor (GFT505) is GENFIT’s lead pipeline product. Elafibranor is an oral once-daily treatment, and a first-in-class drug acting via dual peroxisome proliferator-activated alpha/delta pathways to treat nonalcoholic steatohepatitis (NASH). Elafibranor is believed to address mutliple facets of NASH, including inflammation, insulin sensitivity, lipid/metabolic profile, and liver markers.
About NASH: “NASH”, or nonalcoholic steatohepatitis, is a liver disease characterized by an accumulation of fat (lipid droplets), along with inflammation and degeneration of hepatocytes. The disease is associated with long term risk of progression to cirrhosis, a state where liver function is diminished, leading to liver insufficiency, and also progression to liver cancer.
About GENFIT: GENFIT is a biopharmaceutical company focused on the discovery and development of drug candidates in areas of high unmet medical needs corresponding to a lack of suitable treatment and an increasing number of patients worldwide. GENFIT’s R&D efforts are focused on bringing new medicines to market for patients with metabolic, inflammatory, autoimmune and fibrotic diseases, that affect the liver (such as NASH – Nonalcoholic steatohepatitis) and more generally the gastro-intestinal arena. GENFIT’s approach combines novel treatments and biomarkers. Its lead proprietary compound, Elafibranor (GFT505), completed a Phase 2b study in NASH and is currently in a Phase 3 study. With facilities in Lille, France, and Cambridge, MA (USA), the Company has approximately 100 employees. GENFIT is a public company listed in compartment B of Euronext’s regulated market in Paris (Euronext: GNFT – ISIN: FR0004163111). www.genfit.com
Forward-Looking Statement Disclaimer: This press release contains certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, including related to biomarkers, results of clinical data from the RESOLVE-IT trial, review and approvals by regulatory authorities, such as the FDA or the EMA, regarding Elafibranor and biomarkers, the success of any inlicensing strategies, the Company’s continued ability to raise capital to fund its development, as well as those discussed or identified in the Company’s public filings with the AMF, including those listed under Section 4.2 “Risk Factors” (“Facteurs de Risque”) of the Company’s Annual Financial Report for the year ended December 31, 2015, which is available on GENFIT’s website (www.genfit.com). Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements.
This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in GENFIT in any country. This press release has been prepared in both French and English. In the event of any differences between the two texts, the French language version shall supersede.
GENFIT | Jean-François Mouney – Chairman & CEO | Ph. +333 2016 4000
MILESTONES – Press Relations | Bruno Arabian | Ph. +331 8362 3484 / +336 8788 4726 – firstname.lastname@example.org
GENFIT | 885 Avenue Eugène Avinée, 59120 Loos – FRANCE | +333 2016 4000 | www.genfit.com