GENFIT: New Scientific Data to be Presented During Next AASLD Annual Meeting; Strong Involvement in the First-Ever NASH-TAG Conference
› New data on experimental and clinical NASH biomarkers for the identification of NASH patients to be treated have been selected by the AASLD for presentations during its next Annual Meeting
› GENFIT to be a sponsor of the inaugural NASH-TAG educational conference that will provide highlights on the most relevant advances and challenges in the diagnosis and therapy of NASH
Lille (France), Cambridge (Massachusetts, United States), October 3rd, 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 its participation at two major upcoming medical events: the annual meeting of the AASLD (“The Liver Meeting”, Boston, November 11-15, 2016) and the first-ever NASH-TAG event (Park City, January 6-7, 2017).
“The Liver Meeting” organized by the AASLD is one of the most important meetings organized by – and for – the scientific and medical community specialized in hepatology worldwide. It brings together more than 10,000 scientists, gastroenterologists and hepatologists.
The AASLD has selected several GENFIT abstracts for presentation, including post-hoc analyses of the GOLDEN-505 Phase 2 trial, along with novel results of rodent NASH models compared with human NASH.
– Friday, November 11th
“Assessment of serum levels of Chitinase-3-like protein 1 (CHI3L1) improves identification of the NASH patients at risk who should be treated”, A. Sanyal et al. (Abstract 658)
– Saturday, November 12th
“ALT as a non-invasive biomarker of histological response to pharmacotherapy in NASH patients: insights from the elafibranor GOLDEN-505 trial”, V. Ratziu et al. (Abstract 1154)
– Sunday, November 13th
“Comparison of liver pathology in three rodent NASH models to that observed in human NASH patients”, F. Texier et al. (Abstract 1598)
New announcements will be made in the course of October.
GENFIT participation at the AASLD Annual Meeting 2016:
Elafibranor is currently being evaluated in the RESOLVE-IT Phase 3 clinical study, but the annual meeting of the AASLD will provide an opportunity to shed some light on new data derived from the GOLDEN-505 Phase 2 trial. It will also highlight the potential of promising non-invasive biomarkers identified by GENFIT to improve the identification of NASH patients to be treated.
On this occasion, GENFIT will also host two events:
– Analyst and investor event,
– Biomarker Scientific Advisory Board.
In addition, GENFIT will:
– host a booth (#335) in the exhibitor hall of the John B. Hynes Veterans Memorial Convention Center,
– and Sophie Mégnien, CMO of GENFIT, 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, learned societies, academic and industry stakeholders.
GENFIT supports and will participate at the NASH-TAG Conference 2017:
The NASH-TAG Conference 2017 taking place in Park City, Utah, will provide attendees with the opportunity to exchange about NASH and liver fibrosis. The NASH-TAG Conference is designed to bring together clinicians and researchers in academia and the pharmaceutical industry for a focused interactive educational update highlighting the most relevant advances and challenges in the diagnosis and therapy of NASH and liver fibrosis. Internationally renowned faculty will assist in the development of the educational content and will serve as faculty at the conference. This initiative is driven by four KOLs acting as course directors: Michael Charlton, MBBS, MD, FRCP ; Vlad Ratziu, MD ; Stephen Harrison, MD, FAASLD and Arun J. Sanyal, MD.
As a key player in the NASH space, GENFIT will take an active role in the event, including as a sponsor.
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, France, and Cambridge, MA (USA), the Company has approximately 110 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 (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 | Ph. +333 2016 4000
MILESTONES – Press Relations | Bruno Arabian | Ph. +331 8362 3484 / +336 8788 4726 – firstname.lastname@example.org
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