GENFIT Announces New Data at the European Association for the Study
of the Liver (EASL) Congress 2023
Lille
(France);
Cambridge
(Massachusetts, United
States); Zurich
(Switzerland); June
7,
2023 - GENFIT (Nasdaq and
Euronext: GNFT), a late-stage biopharmaceutical company
dedicated to improving the lives of patients with rare and severe
liver diseases, today announced that it will present new data at
the EASL Congress which will take place on June 21-24, 2023 in
Vienna, Austria.
Posters and Presentations
GENFIT has had three abstracts accepted for
poster sessions. Presentations include preclinical data showing the
beneficial effects of nitazoxanide (NTZ) in an Acute-on-Chronic
Liver Failure (ACLF) disease model, NIS2+™ as an effective
screening tool for optimizing patient selection in clinical trials
targeting at-risk Non-Alcoholic Steatohepatitis (NASH) and NIS2+™
as the most adapted Non-Invasive Test (NIT) for an efficient
identification of at-risk NASH that is not impacted by age.
Poster 1:
Preclinical data showing beneficial
effects of NTZ in an ACLF disease
model
Title: Nitazoxanide counteracts
lipopolysaccharide-induced hepatic and renal transcriptomic profile
changes to improve systemic inflammation and organ damage in a
disease model of acute-on-chronic liver failure
Poster: THU-342
Author/s: Legry V. et al.
Session: June 22, 2023:
Cirrhosis and its complications: Experimental and pathophysiology
(selected for the Poster Tour that will be held between 4:15pm –
5:00pm at the Cirrhosis & complications track hub).
Poster 2: NIS2+™ as an
effective screening tool for optimizing patient selection in
clinical trials targeting at-risk
NASH
Title: NIS2+™ as a screening
tool for optimizing patient selection in nonalcoholic
steatohepatitis therapeutic trials
Poster: SAT-421
Author/s: Ratziu V., Harrison
S.A. et al.
Session: June 24, 2023 between
9.00am – 5.00pm at NAFLD: Diagnostics and non-invasive assessment
(selected for inclusion in the Best of EASL Congress summary slide
deck).
Poster 3: NIS2+™ as
the most adapted Non-Invasive
Test (NIT) for an efficient identification of at-risk NASH that is
not impacted by age
Title: Impact of age as a
confounding factor on non-invasive blood-based tests for the
evaluation of non-alcoholic fatty liver disease (NAFLD): comparing
NIS2+™ to established tests
Poster: SAT-417
Author/s: Anstee, Q.M. et
al.
Session: June 24, 2023 between
9.00am – 5.00pm at NAFLD: Diagnostics and non-invasive
assessment
Key events
GENFIT will host an investigator meeting on June
22, 2023 in relation to the international UNVEIL-IT™ Phase 2 study
which is currently being conducted, evaluating VS-01 in ACLF.
ABOUT EASL
The European Association for the Study of the
Liver (EASL) Annual Congress is a major international conference
for researchers, physicians, and other healthcare professionals in
the field of liver disease. The annual meeting typically features
presentations on the latest research and advances in the diagnosis,
treatment and management of liver conditions, as well as
opportunities for networking and professional development. EASL
Congress 2023 is scheduled to take place in Vienna from June 21st
to 24th 2023 at Messe Wien Exhibition Congress Centre, and will
likely attract more than 9000 attendees worldwide.
ABOUT ACLF
GENFIT’s Acute-on-Chronic Liver Failure (ACLF)
franchise now comprises 3 clinical stage assets (VS-01, NTZ and
SRT-015) based on differentiated mechanisms of action leveraging
complementary pathways.
ACLF is a rare, life-threatening, but
potentially reversible condition of varied etiology. ACLF is
recognized clinically as a syndrome, globally defined by
multi-organ dysfunction and failure in patients with chronic liver
disease or liver cirrhosis and high short-term mortality within a
period of 28 to 90 days.
Patients with cirrhosis may initially be
compensated. With progression, many patients will go on to have
acute decompensation of cirrhosis characterized by the rapid
development of complications such as ascites, hepatic
encephalopathy (HE), gastrointestinal hemorrhage, or bacterial
infection, which are very common causes of hospitalization. On
admission, approximately 30% of these patients will develop liver
and/or other organ failure(s) (i.e, brain, kidneys, cardiovascular
and respiratory) and will be considered as having ACLF.1 2 3 4
5
ABOUT
NIS2+™
NIS2+™ is a blood-based diagnostic test
specifically designed to detect at-risk NASH among patients with
metabolic risk factors based on an independent 2-biomarker panel.
It was developed and validated by GENFIT as a robust Non-Invasive
Test (NIT) across characteristics of interest such as type-2
diabetes, age and sex, allowing large-scale implementation in
clinical practice.
ABOUT GENFIT
GENFIT is a late-stage biopharmaceutical company
dedicated to improving the lives of patients with rare and severe
liver diseases characterized by high unmet medical needs. GENFIT is
a pioneer in liver disease research and development with a rich
history and strong scientific heritage spanning more than two
decades. Thanks to its expertise in bringing early-stage assets
with high potential to late development and pre-commercialization
stages, today GENFIT boasts a growing and diversified pipeline of
innovative therapeutic and diagnostic solutions.
Its R&D pipeline covers six therapeutic
areas via seven programs which explore the potential of
differentiated mechanisms of action, across a variety of
development stages (pre-clinical, Phase 1, Phase 2, Phase 3). These
diseases are acute on-chronic liver failure (ACLF), hepatic
encephalopathy (HE), cholangiocarcinoma (CCA), urea cycle disorder
(UCD), organic acidemias (OA) and primary biliary cholangitis
(PBC). Beyond therapeutics, GENFIT’s pipeline also includes a
diagnostic franchise focused on NASH and ACLF.
GENFIT has facilities in Lille and Paris
(France), Zurich (Switzerland) and Cambridge, MA (USA). GENFIT is a
publicly traded company listed on the Nasdaq Global Select Market
and on compartment B of Euronext’s regulated market in Paris
(Nasdaq and Euronext: GNFT). In 2021, IPSEN became one of GENFIT’s
largest shareholders and holds 8% of the company’s share capital.
www.genfit.com
FORWARD LOOKING STATEMENTS
This press release contains certain
forward-looking statements with respect to GENFIT, including those
within the meaning of the Private Securities Litigation Reform Act
of 1995 in relation to the clinical performance of NIS2+™ in NASH
and NTZ in ACLF patients. The use of certain words, including
“consider”, “contemplate”, “think”, “aim”, “expect”, “understand”,
“should”, “aspire”, “estimate”, “targeted”, “anticipated”,
“believe”, “wish”, “may”, “could”, “allow”, “seek”, “encourage” or
“have confidence” or (as the case may be) the negative forms of
such terms or any other variant of such terms or other terms
similar to them in meaning is intended to identify forward-looking
statements. Although the Company believes its projections are based
on reasonable expectations and 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 in
relation to safety, biomarkers, cost of, progression of, and
results from, its ongoing and planned clinical trials, review and
approvals by regulatory authorities in the United States, Europe
and worldwide, of our drug and diagnostic candidates, exchange rate
fluctuations, potential synergies related to the acquisition of
Versantis, our capacity to integrate its assets, develop its
programs and our continued ability to raise capital to fund our
development, as well as those risks and uncertainties discussed or
identified in the Company’s public filings with the AMF, including
those listed in Chapter 2 “Main Risks and Uncertainties” of the
Company’s 2022 Universal Registration Document filed with the AMF
on April 18, 2023, which is available on the Company’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 2022 Annual
Report on Form 20-F filed with the SEC on April 18, 2023. 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
Tel: +33 3 2016 4000 | investors@genfit.com
PRESS RELATIONS | Media
Stephanie Boyer – Press relations | Tel: +333
2016 4000 | stephanie.boyer@genfit.com
GENFIT | 885 Avenue Eugène Avinée, 59120 Loos -
FRANCE | +333 2016 4000 | www.genfit.com
1 Arroyo V et al., J Hepatol, 2015, 62(1 Suppl), S131-S1432
Malik R et al., J Hepatol, 2009, 51(3), 426-93 Olson JC et al.,
Hepatology, 2011, 54(5), 1864-724 Jalan R et al., J Hepatol, 2012,
57(6), 1336-485 Wlodzimirow KA et al., Liver International, 2013,
33(1), 40-42
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Study of the Liver (EASL) Congress 2023
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