GENFIT : Nouvelles données présentées au Liver Meeting 2019 de
l’AASLD
GENFIT Announces New Data to be Presented
at AASLD Liver Meeting 2019
- Presentations include new data on NIS4’s1 diagnostic
performance in the diabetic population and synergies between
elafibranor2 and nitazoxanide (NTZ), and a GLP1
- Engaging with KOLs via a PBC Investigator meeting and
an Advisory Board on NIS4, GENFIT’s investigational blood based
diagnostic test
- Analyst and Investor KOL luncheon scheduled at
AASLD
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 patientsPoster: #
1757Author/s: R. Hanf et
al.Display: Sunday November 10 – all
dayPresentation: From 12:30pm to 1:30 pm
Title: Elafibranor and
nitazoxanide have complementary actions to protect against
oxidative stress in NASH Poster: #
2227Author/s: C. Foucart et
al.Display: Monday November 11 – all day
Presentation: From 12:30pm to
1:30 pm
Title: Elafibranor synergizes
with semaglutide to reduce liver steatosis in a model of
NASHPoster: #2198Author/s: V.
Legry et al.Display: Monday November 11 – all
dayPresentation: From 12:30pm to 1:30 pm
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:
- A NIS4 Advisory Board will be conducted to
gain valuable insights through dialog and debate on the future of
NASH diagnosis with a diverse panel of clinical experts in the
field. NIS4 is a validated diagnostic test not yet approved by the
FDA, and it is available only for use in clinical research at this
time through a partnership with Covance, a subsidiary of LabCorp®.
GENFIT expects to file for regulatory approval in 2020, with the
objective of providing a simple, non-invasive and cost-effective
diagnostic tool to healthcare providers involved in the clinical
management of patients with NASH.
- A PBC Investigator Meeting will be chaired by
Dr. Jörn Schattenberg, MD, Division of Gastroenterology and
Hepatology, University Medical Center, Mainz (Germany), and Dr.
Kris V. Kowdley, MD Director, Liver Care Network and Organ
Care Research, Swedish Medical Center, Seattle, WA, ahead of the
Phase 3 study, which is expected to start early next year.
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 STATEMENTSThis
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
statements about the company’s expectations for NIS4 regulatory
filing submission and potential to provide a simple, non-invasive
and cost-effective diagnostic tool to all healthcare providers
involved in the clinical management of NASH patients, as well as
the timing of the start of the Phase 3 trial of elafibranor in PBC.
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.
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.2 Elafibranor
is currently investigational and not approved for any
indication.
- GENFIT : Nouvelles données présentées au Liver Meeting 2019 de
l’AASLD