Communication Officielle
Jeudi 31 octobre 2019, 08h30 (il y a 52 mois) GENFIT : Nouvelles données présentées au Liver Meeting 2019 de l’AASLDGENFIT Announces New Data to be Presented at AASLD Liver Meeting 2019
Lille (France), Cambridge (Massachusetts, United States), October 31, 2019 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases, today announced multiple upcoming presentations at The Liver Meeting®, the annual meeting of the American Association for the Study of Liver Diseases (AASLD) to be convened in Boston, MA, November 8 -12, 2019. The Liver Meeting® is one of the most important hepatology congresses for the medical and scientific community. It brings together more than 10,000 scientists, gastroenterologists and hepatologists from around the world. Posters and Presentations Presentations will include a poster on NIS4, GENFIT’s innovative, non-invasive diagnostic blood test to identify individuals with NASH and fibrosis (F>2; NAS >4), specifically on test performance in the diabetic population. In addition, two posters will be presented demonstrating synergistic efficacy of elafibranor in combination with nitazoxanide (NTZ) and in combination with semaglutide. Title: Type 2 diabetes as a risk factor for NASH and fibrosis in a cohort of 2363 patients with suspicion of NAFLD: use of NIS4 for identification of at-risk NASH in diabetic patients Title: Elafibranor and nitazoxanide have complementary actions to protect against oxidative stress in NASH Presentation: From 12:30pm to 1:30 pm Title: Elafibranor synergizes with semaglutide to reduce liver steatosis in a model of NASH Abstracts are available on the meeting’s website. Key events November 11, 2019: GENFIT will host an investor and analyst luncheon discussing the medical community’s approach to challenges in NASH and PBC, with a focus on both therapeutics and diagnosis. Key speakers will include Dr Stephen Harrison, MD, Hepatologist, Medical Director of Pinnacle Clinical Research, San Antonio, TX, (USA) and Dr. Jörn Schattenberg, MD, Division of Gastroenterology and Hepatology, University Medical Center, Mainz (Germany). New insights on the NASH market opportunity, derived from independent market research conducted by IQVIA in 2019 will also be shared by Andy Wong, Senior Principal at IQVIA. The investor and analyst luncheon will be available via webcast. Institutional investors and analysts may RSVP to genfit@troutgroup.com. Throughout the congress, GENFIT will also engage with key medical stakeholders to continue driving the strategic development of GENFIT’s programs:
Booth From November 9 to 11, GENFIT TEAM members will be available for further information regarding the ongoing R&D programs. Two booths will co-exist in the Hynes Convention Center – Hall C: #209 (Genfit Corporate) and #114 (NIS4 Diagnostic Test). For more information please visit the AASLD Annual Meeting website (https://www.aasld.org/event/liver-meeting) or please contact GENFIT Investor and Media departments. ABOUT ELAFIBRANOR Elafibranor is GENFIT’s lead pipeline product candidate. Elafibranor is an oral, once-daily, first-in-class drug acting via dual peroxisome proliferator-activated alpha/delta pathways developed to treat, in particular, nonalcoholic steatohepatitis (NASH), for which it has been granted Fast Track Designation by FDA. GENFIT believes, based on clinical results to date, that elafibranor has the potential to address multiple facets of NASH, including inflammation, insulin sensitivity, lipid/metabolic profile, and liver markers. Phase 2 clinical trial results have also shown that elafibranor may be an effective treatment for PBC, a chronic liver disease. Elafibranor was granted a Breakthrough Therapy Designation by FDA in this indication. ABOUT NIS4 GENFIT is developing an in vitro diagnostic (IVD) test to identify patients with NASH and fibrosis (F>2, NAS>4), who are the focus of current NASH clinical trials. The NIS4 program is based on the in-house discovery of a 4-biomarker algorithm and is currently pursuing commercialization of this test which aims to be a validated alternative to the liver biopsy. In January, 2019, GENFIT signed a licensing agreement with LabCorp® to roll out the diagnostic kit in the clinical research field, and plans to file NIS4 for formal marketing approval with the FDA in 2020. ABOUT NASH “NASH” 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 potential progression to liver cancer. ABOUT PBC Primary biliary cholangitis (PBC) is a chronic, autoimmune disease in which bile ducts in the liver are gradually destroyed. The damage to bile ducts can inhibit the liver’s ability to rid the body of toxins, and can lead to scarring of liver tissue, known as cirrhosis. Elafibranor has shown promising results for the treatment of PBC in a Phase 2 clinical trial and was granted the Breakthrough Therapy Designation by the FDA in this indication. ABOUT GENFIT GENFIT is a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases where there are considerable unmet medical needs, corresponding to a lack of approved treatments. GENFIT is a leader in the field of nuclear receptor-based drug discovery with a rich history and strong scientific heritage spanning almost two decades. Its most advanced drug candidate, elafibranor, is currently being evaluated in a pivotal Phase 3 clinical trial (“RESOLVE-IT”) as a potential treatment for NASH, and GENFIT plans to initiate a Phase 3 clinical trial in PBC next year following its positive Phase 2 results. As part of GENFIT’s comprehensive approach to clinical management of patients with NASH, the company is also developing a new, non-invasive and easy-to-access blood-based in vitro diagnostic test to identify patients with NASH who may be appropriate candidates for drug therapy. With facilities in Lille and Paris, France, and Cambridge, MA, USA, the Company has approximately 200 employees. GENFIT is a publically traded company listed on the Nasdaq Global Select Market and in compartment B of Euronext’s regulated market in Paris (Nasdaq and Euronext: GNFT). www.genfit.com FORWARD LOOKING STATEMENTS CONTACT GENFIT | Investors Naomi EICHENBAUM – Investor Relations | Tel: 1 (617) 714 5252 | investors@genfit.com PRESS RELATIONS | Media Hélène LAVIN – Press relations | Tel: 333 2016 4000 | helene.lavin@genfit.com GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | 333 2016 4000 | www.genfit.com
1 NIS4 is not currently approved as an in vitro diagnostic test (IVD). NIS4 has been licensed to LabCorp for use as a laboratory developed test (LDT) for patients in clinical trials.
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