GENFIT Announces Publication in the Journal of Hepatology on the
Accurate Performance of NIS2+™ as a Screening Tool for the
Enrollment of Patients in MASH Clinical Trials
- The
paper published in Journal of Hepatology
demonstrates that NIS2+™ technology could significantly
reduce liver biopsy failure rate and maximizes accuracy of patient
selection for MASH1 clinical
trials
- Growing
body of clinical evidence: this is the third paper on NIS2+™ that
has been published in a leading medical journal in
2023
Lille (France), Cambridge
(Massachusetts, United States), Zurich (Switzerland), December 6,
2023- 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 publication in the Journal of Hepatology2 of a
paper on the performance of NIS2+™ as a screening tool for the
enrollment of patients in Metabolic Dysfunction–Associated
Steatohepatitis (MASH) clinical trials.
The study highlights NIS2+™’s potential
effectiveness to significantly reduce the number of liver biopsies
required for the enrollment of patients in MASH clinical trials.
The study demonstrates that, for 1,000 inclusions in a trial,
NIS2+™ could significantly reduce the number of unnecessary liver
biopsies being performed (632 vs 1,522; -58%). The data taken from
this study indicate that NIS2+™ may reduce liver biopsy failure
rate to <30% and that NIS2+™ alone performs better than FIB-4
alone (a non-invasive test for fibrosis detection) or combined with
FIB-4.
In MASH clinical trials, patients are referred
to liver biopsy for potential enrollment based on clinical and
biological features that are neither sensitive nor specific,
leading to unacceptably high (>60%) liver biopsy failure rates.
Reducing liver biopsy failure rates using non-invasive tests
represents a high unmet need and an important step towards
accelerating recruitment at optimized cost in future MASH clinical
trials.
Dr. Vlad Ratziu, Professor
at Sorbonne University and Pitié-Salpêtrière Hospital
in Paris, France, stated: “Most late-stage MASH
trials do not have a well-defined, non-invasive strategy for
referring patients to liver biopsy. There is a real need to
maximize the accuracy of the patient selection process by using
better non-invasive predictors of at-risk MASH. NIS2+™ has the
potential to become an accessible and rapid screening tool that
could have a major impact on the feasibility of MASH clinical
trials, including the speed of enrollment.”
Dr. Stephen Harrison,
Chairman and Founder for Pinnacle Clinical Research,
Chairman and Co-Founder of Summit Clinical Research,
USA and Visiting Professor of Hepatology at the Radcliffe
Department of Medicine, University of Oxford, UK,
commented: “Screening patients with NIS2+ would potentially prevent
unnecessary liver biopsies, reducing the likelihood of study
related complications and improve patient satisfaction. It would
also lead to a liver biopsy failure rate decrease, maintaining
timely and cost-efficient completion of MASH clinical trials – a
prerequisite for the testing of the numerous molecules currently in
development.”
A total of three papers on NIS2+™ technology
have been published in leading medical journals this year. Six
posters and two oral presentations featuring complementary data on
the performance of NIS2+™ were also presented this year at key
scientific conferences: NASH-TAG, EASL3, Paris-NASH and AASLD4
TLM.
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
an IVD test powered by NIS2+™ technology in both the United States
and Europe.
ABOUT GENFIT
GENFIT is a late-stage biopharmaceutical company
dedicated to improving the lives of patients with rare and
life-threatening 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. Today, GENFIT has a growing and
diversified pipeline with programs at various development stages.
The Company’s area of focus is Acute on Chronic Liver Failure
(ACLF). Its ACLF franchise consists of five assets in development:
VS-01, NTZ, SRT-015, CLM-022 and VS-02-HE. These are all based on
differentiated mechanisms of action leveraging complementary
pathways. Other assets target other life-threatening disease
indications such as cholangiocarcinoma (CCA) and Urea Cycle
Disorders (UCD)/Organic Acidemias (OA). GENFIT’s track record in
bringing early-stage assets with high potential to late development
and pre-commercialization stages is highlighted in the successful
52-week Phase 3 ELATIVE® trial evaluating elafibranor in PBC.
Beyond therapeutics, GENFIT’s pipeline also includes a diagnostic
franchise focused on Metabolic dysfunction-associated
steatohepatitis (MASH) previously known as nonalcoholic
steatohepatitis (NASH) and ammonia. 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. For more information, visit 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
ability of NIS2+™ to reduce the number of liver biopsies required
to complete patient enrollment in MASH clinical trials, liver
biopsy failure, maximize accuracy of patient selection and lower
costs of MASH clinical trials, as well as reduce likelihood of
study-related complications and improve patient satisfaction. The
use of certain words, including “believe”, “potential,” “expect”,
“target”, “may” 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 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, 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 and
subsequent filings and reports filed with the AMF or SEC, including
the Half-Year Business and Financial Report at June 30, 2023 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
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 At the EASL Congress in June 2023, it was announced that
non-alcoholic steatohepatitis (NASH) would now be referred to as
Metabolic dysfunction-associated steatohepatitis (MASH).2
https://doi.org/10.1016/j.jhep.2023.10.0383 European Association
for the Study of the Liver4 American Association for the Study of
Liver Diseases
- GENFIT Announces Publication in the Journal of Hepatology on
the Accurate Performance of NIS2+™ as a Screening Tool for the
Enrollment of Patients in MASH Clinical Trials
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