GENFIT to Present Latest ACLF Research at EASL Congress™ 2024
Lille (France), Cambridge (Massachusetts,
United States), Zurich (Switzerland), May 29, 2024 -
GENFIT (Nasdaq and Euronext: GNFT), a late-stage
biopharmaceutical company dedicated to improving the lives of
patients with rare and life-threatening liver diseases, today
detailed its presence at the EASL Congress™ 2024.
GENFIT accelerates its research in Acute
on-Chronic Liver Failure (ACLF)
- EF CLIF
and GENFIT partnership event
GENFIT will co-host an event with the European
Foundation for the Study of Chronic Liver Failure (EF CLIF) to mark
the beginning of a research collaboration aimed at advancing the
understanding of ACLF. EF CLIF has conducted several large
prospective observational studies in large numbers of patients
admitted to hospital in Europe and Latin America for acute
decompensation of cirrhosis, helping to better understand the onset
and progression of ACLF.
Professor Richard Moreau, MD, PhD,
Director of EF CLIF Governing Board declared: “I am
delighted to welcome experts to this event jointly organized by
GENFIT and EF CLIF, marking the commencement of our partnership.
This occasion will showcase the collaborative research efforts of
EF CLIF, recognized as a leading authority in ACLF, and GENFIT, a
biotechnology company dedicated to improving care of patients with
ACLF. Together, we aim to advance the understanding of ACLF
pathophysiology and uncover novel approaches for the treatment of
this syndrome.”
Both EF CLIF and GENFIT are committed to working
towards achieving a patient-centered healthcare system and are
pleased to be associated with the Global Liver Institute (GLI) and
the European Liver Patients' Association (ELPA) for the launch of
this initiative.
Speakers include:
- Richard Moreau,
Director of EF CLIF
- Pascal Prigent,
CEO of GENFIT and Dean Hum, Chief Scientific Officer of GENFIT
- Donna R. Cryer,
Founder and CEO of GLI
- Milan
Mishkovikj, ELPA Board Member
“We’re excited to co-host an event with EF CLIF,
a major academic consortium promoting research and education in
liver disease, to improve the prognosis of patients living with
chronic liver failure. The GLI and ELPA will also be invited to
share their insights, to ensure the patient voice is heard,” said
Dean Hum, Chief Scientific Officer of GENFIT.
“We’re also happy to present data from two of our lead programs in
ACLF, as we believe our pipeline offers potential to transform the
treatment paradigm for patients suffering from this syndrome.”
- Poster
#1: blood and peritoneal metabolomics suggest VS-01 actively
captures metabolites associated with ACLF
Poster: #THU-088Author/s: Tyc, O.; Uschner, E.
F.; Trebicka, J. et alSession: Poster Cirrhosis and its
complications: ACLF and Critical Illness
- Poster
#2: Nitazoxanide directly protects from stress-induced cell death
to alleviate liver damage in preclinical models of
ACLF
Poster: #WED-105Author/s: Staels, B.;
Bobowski-Gerard, M. et alSession: Poster – Cirrhosis and its
complications: Experimental and pathophysiology
Other events
-
UNVEIL-IT® Investigator Meeting
GENFIT will be organizing an UNVEIL-IT® meeting
with investigators, key opinion leaders in ACLF, study team members
and pharmacists to discuss the ongoing Phase 2 trial of VS-01 and
to share study experiences. The meeting will provide a unique
opportunity for investigators to gain insights and best practices
from fellow investigators.
- ELPA
educational training event
GENFIT will be presenting its commitment to
patient advocacy and its ACLF programs at the ELPA educational
training event, which aims to raise patient awareness on drug
innovations and medical advances. Members include national patient
associations and caregivers.
ELPA’s aim is to promote the interests of people
with liver disease and, in particular, to promote awareness and
prevention; address the lack of awareness of liver disease as
compared to other areas of medicine such as heart disease; share
experience of successful initiatives; and work with professional
bodies such as EASL and with the EU to ensure that treatment and
care are harmonized across Europe to the highest standards.
ABOUT EASL
The European Association for the Study of the
Liver (EASL) Annual Congress is a major international conference
and brings together over 7,000 professionals, including clinicians,
researchers, allied health professionals, patient representatives,
and industry professionals. It stands out as Europe’s largest event
in this domain. Across four interactive days, participants will
benefit from hands-on learning sessions led by world-class faculty,
presenting a unique opportunity for the liver community to share
research, network, and engage with leading hepatology experts.
ABOUT ACLF
ACLF presents as a syndrome defined by a
combination of hepatic and extrahepatic organ dysfunctions and
failures and a uniformly poor prognosis. In patients with liver
cirrhosis and acute hepatic decompensation, ACLF can be triggered
by a precipitating event (e.g. an infection) that leads to a
progressive functional deterioration of multiple organs with high
short-term mortality (23% to 74% mortality at 28 days1). In 2021,
the prevalence of ACLF was estimated to be approximately 294,000
across the US, EU4, and UK2; a number expected to grow up to ~
300,000 patients by 20363. The incidence is growing at epidemic
rates (+26% between 2006 and 2014) due to an aging population and a
higher prevalence of steatotic liver disease4, diabetes, obesity,
as well as alcohol consumption.
ABOUT GENFIT
GENFIT is a late-stage biopharmaceutical company
committed to improving the lives of patients with rare,
life-threatening liver diseases whose medical needs remain largely
unmet. GENFIT is a pioneer in liver disease research and
development with a rich history and a solid scientific heritage
spanning more than two decades. Today, GENFIT has built up a
diversified and rapidly expanding R&D portfolio of programs at
various stages of development. The Company focuses on
Acute-on-Chronic Liver Failure (ACLF). Its ACLF franchise includes
five assets under development: VS-01, NTZ, SRT-015, CLM-022 and
VS-02-HE, based on complementary mechanisms of action using
different routes of administration. Other assets target other
serious diseases, such as cholangiocarcinoma (CCA), urea cycle
disorder (UCD) and organic acidemia (OA). GENFIT's expertise in the
development of high-potential molecules from early to advanced
stages, and in pre-commercialization, was demonstrated with the
success of the 52-week Phase 3 ELATIVE® study evaluating
elafibranor in Primary Biliary Cholangitis (PBC). Beyond therapies,
GENFIT also has a diagnostic franchise including NIS2+® in
Metabolic dysfunction-associated steatohepatitis (MASH, formerly
known as NASH for non-alcoholic steatohepatitis) and TS-01 focusing
on blood ammonia levels. GENFIT is headquartered in Lille, France
and has offices in Paris (France), Zurich (Switzerland) and
Cambridge, MA (USA). The Company is listed on the Nasdaq Global
Select Market and on the Euronext regulated market in Paris,
Compartment B (Nasdaq and Euronext: GNFT). In 2021, Ipsen became
one of GENFIT's largest shareholders, acquiring an 8% stake in the
Company's capital. 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,
but not limited to, statements about future collaborations with
EF-CLIF and the potential for our pipeline to change the treatment
paradigm for ACLF patients. The use of certain words, such as
"believe", "potential", "expect", “target”, “may”, “will”,
"should", "could", "if" 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 others, the uncertainties inherent in
research and development, including in relation to safety of drug
candidates, cost of, progression of, and results from, our ongoing
and planned clinical trials, review and approvals by regulatory
authorities in the United States, Europe and worldwide, of our drug
and diagnostic candidates, potential commercial success of
elafibranor if approved, exchange rate fluctuations, 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 "Risk Factors and Internal Control" of the Company's 2023
Universal Registration Document filed on April 5, 2024 (no.
D.24-0246) with the Autorité des marchés financiers ("AMF"), which
is available on GENFIT's website (www.genfit.fr) and the AMF's
website (www.amf.org), and those discussed in the public documents
and reports filed with the U.S. Securities and Exchange Commission
("SEC"), including the Company’s 2023 Annual Report on Form 20-F
filed with the SEC on April 5, 2024 and subsequent filings and
reports filed with the AMF or SEC or otherwise made public, by the
Company. In addition, even if the results, performance, financial
position and liquidity of the Company 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., Nat. Rev. Dis. Primers 2 (2016)2 IQVIA market
research3 IQVIA market research4 Axley P, Ahmed Z, Arora S, Haas A,
Kuo YF, Kamath PS, Singal AK. NASH Is the Most Rapidly Growing
Etiology for Acute-on-Chronic Liver Failure-Related Hospitalization
and Disease Burden in the United States: A Population-Based Study.
Liver Transpl. 2019 May;25(5):695-705. doi: 10.1002/lt.25443. PMID:
30861321
- GENFIT to Present Latest ACLF Research at EASL Congress™
2024
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