Genfit: GENFIT Announces Upcoming Presentations on NASH, PBC and Diagnostics at the European Association for the Study of the Liver (EASL) International Liver Congress 2019
GENFIT Announces Upcoming Presentations on NASH, PBC and Diagnostics at the European Association for the Study of the Liver (EASL) International Liver Congress 2019
-- Elafibranor Phase 2 data in PBC accepted for late-breaker oral presentation
Lille (France), Cambridge (Massachusetts, United States), April 4, 2019 – GENFIT (Nasdaq and Euronext: GNFT - ISIN: FR0004163111), 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 it will present new data at the International Liver Congress (ILC) 2019, which will take place April 10-14 in Vienna, Austria.
Jean-François Mouney, Chairman & CEO of GENFIT, commented: “With our upcoming Phase 3 interim data in NASH, that we expect to publish towards year-end, as well as our recent Nasdaq IPO, this is a pivotal year for GENFIT, and also for the broader NASH space given recent news from the sector. We are pleased that EASL has granted GENFIT a late-breaker oral presentation, providing the first opportunity for us to present the full, positive Phase 2 data for elafibranor in PBC. We also look forward to sharing further insights about our NIS4 in-vitro diagnostic program in NASH which has the potential to provide – for all stakeholders in NASH – an innovative and simple tool to diagnose NASH patients eligible for treatment. We continue to expand our pre-commercialization efforts globally, with a growing number of seasoned pharmaceutical professionals joining our US team.
GENFIT has four abstracts accepted for oral and poster presentations highlighting the clinical results of elafibranor, a dual alpha/delta PPAR agonist, including a late breaker presentation on the Phase 2 results in primary biliary cholangitis (PBC) that was selected as “Best of ILC 2019”. The oral communication will focus on the 12-week, Phase 2 trial in patients with inadequate response to ursodeoxycholic acid (UDCA) who met the primary objective of reduction of alkaline phosphatase (ALP) vs placebo (p<0.001). Elafibranor also had a strong effect on the composite endpoint used in pivotal trials and accepted for drug registration, and demonstrated strong and highly significant anticholestatic effects on other key secondary endpoints and disease related markers with no emergent safety concern observed. GENFIT plans to further evaluate the efficacy and safety of elafibranor, as well as its potential anti-pruritic effect, in a Phase 3 trial expected to initiate later this year.
Additional presentations detail GENFIT’s ongoing approach to evaluating elafibranor as the basis for combination therapies in NASH, specifically in the poster “Elafibranor, a drug candidate for first line NASH monotherapy and a universal backbone for drug combination treatment,” and in an oral presentation “Elafibranor and nitazoxanide synergize to reduce fibrosis in a NASH model” on 4/13/19 from 8:30 – 8:45AM, that will highlight new results on the complementary actions of both GENFIT drug candidates, elafibranor and nitazoxanide, to reduce fibrosis in NASH.
Lastly, a poster presentation will provide key insights on the use of clinically meaningful threshold NIS4 values for non-invasive screening of patients with risk factors for NASH and accurate identification of patients who should be considered for pharmacological intervention (NASH with NAS≥4 and significant fibrosis defined as F≥2).
Abstracts are available for download and viewing through the International Liver Congress website.
LATE-BREAKER ORAL PRESENTATIONS
Title: Elafibranor, a peroxisome proliferator-activated receptor alpha and delta agonist demonstrates favourable efficacy and safety in patients with primary biliary cholangitis and inadequate response to ursodeoxycholic acid treatmentPresentation Number: LB-02 (Late-Breaker)Presenter: Velimir A. C. Luketic, MDAuthors: J. Schattenberg et alSession: Saturday, April 13, 2019, 4:15pm – 4:30pm
Title: Elafibranor and Nitazoxanide Synergize to Reduce Fibrosis in a NASH Model Presentation Number: PS -131Authors: C. Belanger et alSession: Saturday, April 13, 2019, 8:30am – 8:45am
Title: Elafibranor, a Drug Candidate for First Line NASH Monotherapy and a Universal Backbone for Drug Combination TreatmentPresentation Number: FRI-355Authors: V. Legry et alSession: Friday, April 12, 2019
Title: Assessment of NIS4 clinical utility for identification of patients with active NASH (NAS>=4) and significant fibrosis (F>=2) in patients at risk of NASHPresentation Number: SAT-299Authors: R. Hanf et alSession: Saturday, April 13, 2019
GENFIT SPONSORED SYMPOSIUM
-- Thursday, April 11 (7:30 am – 8:30 am, Room Strauss 1-2): Sponsor of a satellite symposium: “Towards a comprehensive management of patients with chronic non-viral liver diseases: NASH & PBC” animated by Mary E. Rinella, MD (Chair); Quentin Anstee, BSc (Hons), MB BS, PhD; Vlad Ratziu, MD, PhD; Jörn M. Schattenberg, MD and Donna Cryer, JD; -- Friday, April 12: KOL event focused on the NASH/PBC space for institutional investors and research analysts, with Vlad Ratziu, MD, PhD and Jörn M. Schattenberg, MD; -- Friday, April 12: Investigator meeting on PBC clinical trials chaired by Jörn M. Schattenberg, MD; -- GENFIT and its awareness initiative The NASH Education Program™ will be exhibiting at booth #240 throughout the meeting. Following last year’s success, The NASH Education Program™ is proud to be part of the 2nd International NASH Day, June 12, led by a consortium of patient advocacy organizations, medical and professional societies, spearheaded by the Global Liver Institute.
For more information please visit the EASL Annual Meeting website or please contact GENFIT Investor and Media departments.
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). 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 rare liver disease.
“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 failure, and also progression to liver cancer.
“PBC” is a chronic 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.
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 later this year following its positive Phase 2 results. As part of GENFIT’s comprehensive approach to clinical management of NASH patients, 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 150 employees. GENFIT is a public company listed on the Nasdaq Global Select Market and in compartment B of Euronext’s regulated market in Paris (Nasdaq and Euronext: GNFT- ISIN: FR0004163111). www.genfit.com
FORWARD LOOKING STATEMENTS
This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995, with respect to Genfit, including, the timing of the release of our Phase 3 interim data in NASH and the potential of our diagnostic test. The use of certain words, including “believe,” “potential,” “expect” and “will” and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on the current expectations and reasonable assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown 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 safety, biomarkers, progression of, and results from, its ongoing and planned clinical trials, review and approvals by regulatory authorities of its drug and diagnostic candidates and the Company’s continued ability to raise capital to fund its development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the French Autorité des marchés financiers (“AMF”), including those listed in Section 4 “Main Risks and Uncertainties” of the Company’s 2018 Registration Document filed with the AMF on February 27, 2019 under n° D.19-0078, which is available on GENFIT’s website (www.genfit.com) and on the website of the AMF (www.amf-france.org) and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s final prospectus dated March 26, 2019, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public, by the Company. In addition, even if the Company’s results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this document. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise.
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-- 2019.04.04 - PR GENFIT - EASL ILC 2019