GENFIT Announces the Publication of New Data on the Clinical
Performance of NIS2+™ in Older Patients in Hepatology
Communications
Lille
(France);
Cambridge
(Massachusetts, United
States); Zurich
(Switzerland); August
10,
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 new data on the
clinical performance of NIS2+™ in older patients, for the detection
of at-risk nonalcoholic steatohepatitis (NASH) in Hepatology
Communications1.
In conjunction with Labcorp, a global leader of
innovative and comprehensive laboratory services, data reported in
the manuscript is the first to show and compare the clinical
performance of NIS4® and its recently developed and improved
upgrade NIS2+™ in a population of older adults (≥65 years of age)
with well-established biomarker panels: FIB-4, NFS, ELF and
ALT.
While previously published data showed that
NIS2+™ had a high overall clinical performance for the detection of
at-risk NASH achieving an AUROC2 of 0.81 in a large study
population, the Centers for Medicare & Medicaid Services (CMS)
in the US requires peer-reviewed, published data showing that
tests, that will be used for patient management, have high assay
performance in patients who are ≥65 years of age. Results of this
study showed the clinical performance of NIS2+™ was superior to
other tests for the diagnosis of at-risk NASH in patients ≥65 years
of age, greatly assisting with CMS reimbursement efforts. These
data support the clinical value of this blood-based test for the
diagnosis of at-risk NASH in older adults who would benefit from
intensive lifestyle or therapeutic interventions.
Arun J Sanyal, MD, FAASLD,
commented: “I am delighted to see this work published. At-risk NASH
is a serious condition that is commonly present in those 65 years
or older and can progress silently to cirrhosis. This study
demonstrates that the NIS2+™ test can be used to identify this
population, and provides clinicians a tool that can be used in
primary care settings to identify patients with this condition, so
that they can engage in more aggressive management strategies or
triage them for tertiary care. Such simple, yet validated, tools
are not widely available, and they represent an important addition
to the diagnostic armamentarium for metabolic
dysfunction-associated steatotic liver disease.”
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 of a successful Phase III trial (ELATIVE®) evaluating
elafibranor in Primary Biliary Cholangitis (PBC) and 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 disorders (UCD), organic
acidemias (OA) and 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. 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 NIS2+™ in NASH
and its reimbursement by the Centers for Medicare & Medicaid
Services (CMS) in the US. 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
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 https://www.doi.org/10.1097/HC9.00000000000002232 Area Under
the Receiver Operating Characteristics
- GENFIT Announces the Publication of New Data on the Clinical
Performance of NIS2+™ in Older Patients in Hepatology
Communications
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