GENFIT: Presentations at EASL 2018 Annual Congress Highlight Progress in NASH Diagnostics, Combination Therapies and Deep-learning Applications in Medical Imaging
Lille (France), Cambridge (Massachusetts, United States), March 28th, 2018 – 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 20181, which will take place April 11-15 in Paris, France.
Two abstracts will highlight the Company’s latest progress in development of a new non-invasive in vitro diagnostic (IVD) test for NASH:
(i) A translational study emphasizing the central role of miR-34a in the development of NASH and the use of circulating level of miR-34a for assessment of hepatic lesions;
(ii) A late breaker abstract providing the clinical validation of NIS4 algorithm for detection of NAFLD patients at risk of cirrhosis. Using the first 500 patients screened for inclusion in the RESOLVE-IT trial, these new results confirm the strong diagnostic performances of NIS4 compared to existing scores and pave the way to development of a new IVD test.
Following recent data that revealed unsuspected anti-fibrotic properties of FDA-approved nitazoxanide (NTZ), a new study will be presented, supporting the rationale for elafibranor/NTZ combination for the best possible care of NASH patients. In this study, NTZ complements low dose elafibranor to reduce fibrosis in a preclinical NASH model.
Lastly, a late breaker abstract will present the discovery of a deep-learning approach and its relevance in quantifying histological NASH parameters.
The abstracts are available on the website of the Congress.
Thursday April 12, 2018
– “Expression profiling of 728 miRNAs in a NASH model identifies excellent correlations of hepatic and circulating miR-34a levels with histological lesions in rats and men”, G. Cordonnier et al. (THU-482)
– “Elafibranor and nitazoxanide synergize to reduce fibrosis in a NASH model”, R. Walczak et al. (THU-494)
From Thursday, April 12 to Saturday, April 14, 2018
– “Validation of NIS4 algorithm for detection of NASH at risk of cirrhosis in 467 NAFLD patients prospectively screened for inclusion in the RESOLVE-IT trial”, R. Hanf et al. (LBP-020)
– “A deep-learning approach for pattern recognition allows rapid and reproducible quantification of histological NASH parameters: integration into the QuPath platform”, E. Rexhepaj et al. (LBP-031)
GENFIT participation at the ILC 2018
– Friday, April 13: GENFIT will host a KOL lunch focused on the NASH/PBC space for institutional investors and research analysts, with S. A. Harrison, MD, V. Ratziu, MD, PhD and V. A. Luketic, MD;
– S. Mégnien, CMO of GENFIT and member of the Steering Committee of the Liver Forum, will co-chair a working group of the Liver Forum #8, 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 #120 throughout the meeting.
GENFIT support of The NASH Education Program™
GENFIT supports the transversal and non-profit initiatives conducted by The NASH Education Program™ and its international scientific committee.
– Friday, April 13 (6:30 pm – 8:00 pm, Room South 1): GENFIT will support a satellite symposium organized by The NASH Education Program™: “Game changers in NASH management” animated by R. Loomba, MD, MHSc (Chair); V. Ratziu, MD, PhD; J-F. Dufour, MD; S. Francque, MD, PhD;
– GENFIT encourages attendees to stop by The NASH Education Program™’s booth #350 to get more information on the International NASH Day initiative, the growing coalition committed to leading the battle against NASH, and which will take place on June 12, 2018.
For more information please visit the EASL Annual Meeting website.
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.
“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.
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 and the trial of elafibranor in PBC, 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 drug candidates in other indications and biomarkers candidates, 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 in Chapter 7 of the 2017 Half Year Business and Financial Report and under Section 4 “Main Risks and Uncertainties” of the Company’s 2016 Registration Document registered with the French Autorité des marchés financiers on April 28, 2017 under n° R.17-034, which is available on GENFIT’s website (www.genfit.com) and on the website of the AMF (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.
GENFIT | Jean-François Mouney – Chairman & CEO | +333 2016 4000
PRESS RELATIONS | Bruno Arabian | +336 8788 4726