Lille (France), Cambridge (Massachusetts,
United States), Zurich (Switzerland), June 17, 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
announced the inclusion of NIS2+® as a key tool for detecting
at-risk MASH1 in the European Clinical Practice Guidelines on the
management of metabolic dysfunction-associated steatotic liver
disease (MASLD).
The guidelines were developed as a joint effort
by the European Association for the Study of the Liver (EASL), the
European Association for the Study of Diabetes (EASD), and the
European Association for the Study of Obesity (EASO), and provide
healthcare providers an update on prevention, screening, diagnosis,
follow-up and treatment for MASLD. The new guidelines were
presented during the EASL congress 2024, and were released in the
Journal of Hepatology2.
“The inclusion of NIS2+® in the EASL-EASD-EASO
clinical guidelines is a major scientific recognition based on
solid evidence that NIS2+® could play an important role in
identifying patients that may benefit from emerging treatments for
MASH,” commented Dean Hum, Chief
Scientific Officer at GENFIT.
“Additionally, GENFIT’s diagnostic technology featured as a
monitoring treatment response in a Phase 2 study on tirzepatide’s
safety and efficacy for MASH, and was recently presented during the
Late Breaking session at EASL and jointly published in the New
England Journal of Medicine3,” he added.
In the new guidelines, NIS2+® is included for
the first time as a non-invasive tool to detect at-risk MASH, and
is the only blood-based panel mentioned for this condition. With
the recent U.S Food and Drug Administration approval of resmetirom
in the US, and given that liver biopsy will be used sparingly in
routine clinical practice due to its invasiveness and
procedure-related limitations, alternative non-invasive panels with
high predictive value validated for the detection of at-risk MASH
such as NIS2+®, could play an important role in selecting
individuals able to benefit from pharmacotherapy.
The new Clinical Practice Guidelines on the
management of MASLD can be found at:
https://www.journal-of-hepatology.eu/article/S0168-8278(24)00329-5/fulltext
ABOUT MASH
MASH is a liver disease characterized by an
accumulation of fat (lipid droplets), along with inflammation and
degeneration of hepatocytes. The disease is associated with an
increased risk of cardiovascular disease along with long-term risk
for progression to cirrhosis, leading to liver insufficiency and
potential progression to liver cancer. MASH is a serious disease
that often carries no symptoms in its early stages, but if left
untreated can result in cirrhosis, cancer, and the need for liver
transplant. The prevalence of MASH is rapidly increasing as a
result of the growing obesity and diabetes epidemics and is
believed to affect as much as 12 percent of people in the U.S. and
six percent worldwide.
ABOUT NIS2+®
NIS2+® is a blood-based diagnostic technology
specifically designed to detect at-risk MASH among patients with
metabolic risk factors based on an independent 2-biomarker panel.
It is an optimization of the NIS4® technology and was
developed and validated by GENFIT as a robust technology across
characteristics of interest such as type-2 diabetes, age and sex,
allowing large-scale implementation in clinical practice. GENFIT
continues to explore the possibility of obtaining regulatory
approval and CE Certificates of Conformity, for the widespread use
of an IVD test powered by NIS2+® technology in both the United
States and Europe.
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 in the FDA’s
accelerated approval of Iqirvo® (elafibranor4) for 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 the
potential for NIS2+® to play an important role in identifying
patients that may benefit from emerging treatments for MASH. 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
GENFIT | 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 Metabolic dysfunction-associated steatohepatitis2 DOI:
https://doi.org/10.1016/j.jhep.2024.04.0313 DOI:
https://doi.org/10.1056/NEJMoa2401943 4 Elafibranor will be
marketed and commercialized by Ipsen under the trademark Iqirvo and
may be prescribed immediately in the U.S. for eligible
patients.
- GENFIT: New EASL-EASD-EASO Clinical Practice Guidelines for
MASLD Include NIS2+® as Key Tool for Detecting At-Risk MASH
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