Data to be Presented at EASL 2017 Highlighting GENFIT's Latest Progress in NASH Biomarker Diagnostics, Identifying Novel Compounds with Potent Antifibrotic Properties, and Illustrating the Opportunities in Anti-NASH Drug Combinations
Lille (France), Cambridge (Massachusetts, United States), April 5 th , 2017 - 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 new data at the International Liver Congress 2017 [1] , which will be held April 19-23 in Amsterdam, The Netherlands. The abstracts are available on the website of the Congress.
A first series of data will underline, via two abstracts, the Company's latest progress in its non invasive biomarker diagnostics in NASH. Data will also be presented on the discovery of nine miRNAs and their relevance in identifying NASH patients to be treated, and a simple diagnostic score for patients and monitoring of their disease.
The progress presented in a third abstract will support the rationale for the repurposing of nitazoxanide (NTZ), currently prescribed as an antiparisitic, in the treatment of different fibrotic disorders, including liver fibrosis.
A final abstract, presenting data on the therapeutic complementarity of elafibranor and an FXR agonist (exemplified with obeticholic acid), will illustrate the potential for new combination treatments with elafibranor for the best possible care of NASH patients.
The poster presentations:
From Thursday, April 20 to Saturday, April 22, 2017
- "A new non-invasive diagnostic score to monitor change in disease activity and predict fibrosis evolution in patients with NASH", S. A. Harrison et al. (LBP-534)
- "Next-Generation Sequencing (NGS) of two independent cohorts identifies eleven circulating miRNAs for diagnosis of NASH and fibrosis", S. Francque et al. (LBP-535)
- "Combination drug therapy allows synergistic therapeutic dose reduction in NASH: a case study of elafibranor (GFT505) and an FXR agonist combination in a model of severe NASH", V. Ratziu et al . (LBP-542)
Saturday, April 22, 2017
- "Drug repurposing screen identifies novel small molecule compounds with potent antifibrotic properties", C. Belanger et al. (SAT-345)
GENFIT participation at the International Liver Congress 2017:
GENFIT will host two events:
- Wednesday, April 19 (18:00 - 19:30, Room Elicium 1): Through its endowment fund, The NASH Education Program(TM), a satellite symposium on "Advances in biomarkers and trial endpoints for NASH and liver fibrosis", animated by S. A. Harrison, MD (Co-Chair); V. Ratziu, MD, PhD (Co-Chair); R. Loomba, MD, PhD; M. Romero-Gomez, MD, PhD; and Q. M. Anstee, BSc(Hons), MBBS, PhD;
- Friday, April 21: A KOL lunch focused on the NASH space for institutional investors and research analysts, with V. Ratziu, MD, PhD and J-F. Dufour, MD, PhD.
In addition:
- Sophie Mégnien, CMO of GENFIT and member of the Steering Committee of the Liver Forum, will co-chair a working group of the Liver Forum #6, which aims to optimize drug development for the treatment of NASH patients in collaboration with regulatory agencies, learned societies, as well as academic and industry stakeholders;
- GENFIT will be exhibiting at booth #35 throughout the meeting.
For more information please visit the EASL Annual Meeting website: https://ilc-congress.eu/
About elafibranor:
Elafibranor 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 developed to treat, in particular, nonalcoholic steatohepatitis (NASH). Elafibranor is believed to address multiple 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, is currently in a Phase 3 study. With facilities in Lille and Paris, France, and Cambridge, MA (USA), the Company has approximately 130 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, progression of, and results of clinical data from, the RESOLVE-IT trial, review and approvals by regulatory authorities, such as the FDA or the EMA, regarding in particular, elafibranor in NASH and PBC, as well as other indications, 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 7 "Main Risks and Uncertainties" of the Company's Half Year 2016 Business and Financial Report, which is available on GENFIT's website ( www.genfit.com ) and on the website of the AMF ( http://www.amf-france.org ). 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.
CONTACT GENFIT | Jean-François Mouney - Chairman & CEO | Ph. +333 2016 4000 MILESTONES - Press Relations | Bruno Arabian | Ph. +331 8362 3484 / +336 8788 4726 - barabian@milestones.fr GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 | www.genfit.com
[1] The 52 nd Annual Meeting of the European Association for the Study of the Liver (EASL)
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