GENFIT Announces Publication in Nature Medicine Confirming the
Performance of its NASH Diagnostic Technology
Lille
(France);
Cambridge
(Massachusetts, United
States); Zurich
(Switzerland); September
26,
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 the publication of data
demonstrating the effectiveness of its non-alcoholic
steatohepatitis (NASH)1 diagnostic technology NIS4® by the FNIH’s2
NIMBLE3 project in the scientific journal, Nature Medicine4.
NIMBLE, part of the FNIH Biomarkers Consortium, is a
public-private partnership that brings together U.S. government
agencies, academic researchers and industry partners to study the
diagnostic performance of non-invasive biomarkers to assess liver
disease. The recent study evaluated five blood-based panels5, which
included NIS4®, NIS2+™’s predecessor.
The study aims to confirm the diagnostic
performances of existing biomarker panels and determine their
advantage over commonly used laboratory tests (ALT and FIB-4). Such
studies conducted provide necessary data for the regulatory
approval of biomarkers for the diagnosis of at-risk NASH and is a
crucial step in moving the field closer to having qualified
Non-Invasive Tests, such as NIS4® or now NIS2+™, that can be used
for widespread clinical use.
The findings, published in the scientific
journal Nature Medicine, concluded that NIS4® achieved an AUROC6 of
0.815 for its intended use of diagnosing at-risk NASH,
demonstrating significant superiority over common
clinical-laboratory tools. It also confirmed that NIS4® was the
only panel efficient for the diagnosis of the composite phenotype
of at-risk NASH. Regarding the detection of NASH and significant
fibrosis (F≥2) independently, NIS4®’s performance was superior to
the other biomarker panels tested, achieving AUROC values of 0.832
and 0.874, respectively.
These findings represent an important milestone
in NIS4® technology’s path to regulatory approval by the U.S Food
and Drug Administration. NIS2+™, the newly published and optimized
version of NIS4®, is currently in the process of being
independently evaluated through the NIMBLE consortium.
Arun J Sanyal,
M.D., Director of
the Stravitz-Sanyal Institute for Liver Disease
and Metabolic Health at Virginia Commonwealth
University and Chair of the NIMBLE
Consortium, commented: “Such findings will bring us a step
closer towards a fully approved biomarker panel which can be made
available for widespread clinical use and potentially alleviate the
major barrier to care and drug development access. NIS4®’s utility
as an effective technology to diagnose at-risk NASH is clearly
demonstrated in these findings and we look forward to evaluating
NIS4®’s more advanced version, NIS2+™, in the near future.”
ABOUT GENFIT’S NASH
DIAGNOSTIC TECHNOLOGY
NIS2+™ is a blood-based diagnostic technology
specifically designed to detect at-risk NASH 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, with a development and commercial
partner, to release an IVD test powered by NIS2+™ technology on the
US and European markets.
NIS4® technology, NIS2+™’s predecessor, is being
commercialized by Labcorp in the US and Canada as a Laboratory
Developed Test. Since May 2021, Labcorp has been commercializing
NASHnext®, powered by NIS4® technology, for use in the clinic. For
more information, visit: https://nis4.com
ABOUT THE FNIH
BIOMARKERS CONSORTIUM
The Foundation for the National Institutes of
Health’s Biomarkers Consortium (BC) leads cross-sector efforts to
validate and qualify biomarkers that accelerate the development of
new therapeutics and health technologies. The core operations of
the BC are supported through its contributing membership program,
which includes organizations representing private industry and
not-for-profit organizations.
ABOUT THE
FNIH
The Foundation for the National Institutes of
Health (FNIH) builds public-private partnerships that connect
leading biomedical scientists at the National Institutes of Health
(NIH), life sciences companies, foundations, academia, and
regulatory agencies, including the Food and Drug Administration and
European Medicines Agency. Through team science, the FNIH solves
complex health challenges and accelerate breakthroughs for
patients, regardless of who they are or what health challenges they
face. The FNIH accelerates new therapies, diagnostics, and
potential cures; advances global health and equity in care; and
celebrates and helps train the next generations of scientists.
Established by Congress in 1990 to support the mission of the NIH,
the FNIH is a not-for-profit 501(c)(3) charitable organization. For
more information about the FNIH, please visit fnih.org
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. Its
capacity to develop high potential assets, from early-stages to
late development and pre-commercialization stages, is illustrated
through the successful 52-week readout of its Phase 3 trial
(ELATIVE®) evaluating elafibranor in Primary Biliary Cholangitis
(PBC). Today, GENFIT has a diversified R&D pipeline covering
several therapeutic areas: five programs in acute on chronic liver
failure (ACLF) are in clinical stages (Phase 2) and pre-clinical
stages, including hepatic encephalopathy (HE), one of the main
complications of ACLF; a Phase 2 clinical program targeting
cholangiocarcinoma; and a preclinical program targeting urea cycle
disorders (UCD) and organic acidemias (OA). GENFIT’s pipeline also
includes a diagnostic franchise focused on Metabolic
dysfunction-associated steatohepatitis (MASH, formerly known as
nonalcoholic steatohepatitis or 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 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 NIS4® and NIS2+™
in NASH and its potential for regulatory approval and utility in
the clinical setting. 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
GENFIT | Press relations
Stephanie Boyer | 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 NASH
would now be referred to as Metabolic dysfunction-associated
steatohepatitis (MASH).2 Foundation for the National Institutes of
Health3 Non-invasive Biomarkers of Metabolic Liver Disease4
https://doi.org/10.1038/s41591-023-02527-w5 NIS4®, OWLiver, PROC3,
ELF™ and FibroMeter VCTE6 Area under the receiver operating
characteristic curve
- GENFIT Announces Publication in Nature Medicine Confirming the
Performance of its NASH Diagnostic Technology
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