(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)
4 posters
› 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 ROR?T INHIBITION IN THE LIVER PREVENTS HEPATIC FIBROSIS PROGRESSION, A PROOF OF CONCEPT STUDY WITH A POTENT, FIRST IN CLASS, HEPATOCENTRIC ROR?T 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
In addition: › 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:
http://www.easl.eu/discover/events/international-liver-congress
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
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)
4 posters
› 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 ROR?T INHIBITION IN THE LIVER PREVENTS HEPATIC FIBROSIS PROGRESSION, A PROOF OF CONCEPT STUDY WITH A POTENT, FIRST IN CLASS, HEPATOCENTRIC ROR?T 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
In addition: › 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:
http://www.easl.eu/discover/events/international-liver-congress
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
