GENFIT Announces Results of NIS4, an Investigational Non-Invasive
NASH Diagnostic, at AASLD 2019
GENFIT Announces Results of NIS4, an
Investigational Non-Invasive NASH Diagnostic, at AASLD
2019
- NIS4 is GENFIT’s innovative non-invasive in
vitro diagnostic test, or IVD, to identify patients with NASH
who may be appropriate candidates for drug therapy
- Program is based on the in-house discovery of a
4-biomarker algorithm potentially replacing biopsy with a single
blood test
- Study finds patients living with type 2 diabetes are at
increased risk of being diagnosed with NASH
Lille (France), Cambridge
(Massachusetts, United States), November 10, 2019
– GENFIT (Nasdaq and Euronext: GNFT), a late-stage
biopharmaceutical company dedicated to the discovery and
development of innovative therapeutic and diagnostic solutions in
metabolic and liver related diseases, today announced results from
a study demonstrating NIS4, an innovative non-invasive diagnostic
blood test designed to diagnose nonalcoholic steatohepatitis
(NASH), outperformed other non-invasive diagnostics in identifying
NASH in people with type 2 diabetes. These data will be presented
at AASLD The Liver Meeting® 2019 in Boston today, November 10 from
12:30PM-1:30PM (Poster #1757).
The study titled, “Type 2 diabetes as a risk
factor for NASH and fibrosis in a cohort of 2363 patients with
suspicion of NAFLD: use of NIS4 for identification of at-risk NASH
in diabetic patients” explores how type 2 diabetes is a risk-factor
for NASH and liver fibrosis, and also compares the diagnostic
performance of NIS4 vs other non-invasive blood marker-based scores
in a population of patients with type 2 diabetes. Cohort 1 (N=820)
assessed the influence of type 2 diabetes status and anti-diabetic
treatment on the prevalence of NAS>4 and F>2, while cohort 2
(N=275) assessed the diagnostic performance of NIS4 in patients
with type 2 diabetes.
The data show that of the patients in Cohort 1,
the presence of type 2 diabetes is associated with increased
prevalence of active NASH (NAS>4) and significant fibrosis
(F>2), i.e. at risk of progression to serious liver outcomes.
The probability of having NAS>4 with F>2 increases with the
number of additional anti-diabetic therapies taken by patients to
control their glycemia, irrespective of the antidiabetic drug
classes used, whether insulin or non-insulin drugs. The data
accentuate the need for active surveillance of liver injury in
patients with type 2 diabetes, in order to identify those at need
of intervention to prevent evolution to clinically relevant hepatic
outcomes.
The data from cohort 2 also show that NIS4
significantly outperformed existing non-invasive diagnostic tests
in accurately identifying NASH (NAS>4) and significant fibrosis
(F>2) in patients with type 2 diabetes. Specifically, NIS4 had
an area under receiver operating characteristic (AUROC) performance
of 0.801 [0.748; 0.854] (p<0.01) that is statistically superior
compared to FIB41 (0.704 [0.641; 0.767]), NFS2 (0.597; [0.527;
0.667]), ELF3 (0.704. [0.642; 0.766]) and Fibrometer (0.678,
[0.613; 0.743]). Therefore, NIS4 can demonstrate good diagnostic
performance and accurately identify NASH (NAS>4) and significant
fibrosis (F>2) in patients with type 2 diabetes.
“These results reiterate the potential
superiority of NIS4, our in-house developed four biomarker panel,
to statistically identify NASH and fibrosis with superior
sensitivity and specificity also observed in patients with type 2
diabetes,” said Suneil Hosmane, Ph.D., Head of Global
Diagnostics at GENFIT. “Our ongoing research in this area
underscores our commitment to improving diagnosis and treatment
experiences for patients with NASH, a potentially life-threatening
disease that is on the rise, yet significantly underdiagnosed.”
“The findings presented today are great
news for researchers, clinicians and people who are at-risk for
NASH. This simple blood test will be instrumental in the NASH
patient journey and provide physicians with the tool to identify
patients in need of therapeutic intervention,” said Stephen
Harrison, study author and Medical Director of Pinnacle Clinical
Research. “While liver biopsy is the current clinical
reference standard for diagnosis, it is a costly, invasive
procedure that can cause pain and discomfort for patients, and can
even have serious, life-threatening complications. Currently there
are no minimally-invasive tests approved specifically for NASH,
which is expected to soon be the primary cause of liver
transplant.”
ABOUT NIS4
GENFIT is developing an in vitro diagnostic
(IVD) test to identify patients with NASH and fibrosis (F>2,
NAS>4), who are the focus of current NASH clinical trials. The
NIS4 program is based on the in-house discovery of a 4-biomarker
algorithm and is currently pursuing commercialization of this test
which aims to be a validated alternative to the liver biopsy. In
January, 2019, GENFIT signed a licensing agreement with LabCorp® to
roll out the diagnostic kit in the clinical research field, and
plans to file NIS4 for formal marketing approval with the FDA in
2020.
ABOUT NASH
NASH is a liver disease characterized by an
accumulation of fat (lipid droplets), along with inflammation and
degeneration of hepatocytes. The disease is associated with long
term risk of progression to cirrhosis, a state where liver function
is diminished, leading to liver insufficiency, and also potential
progression to liver cancer. NASH is a serious disease that often
carries no symptoms in its early stages, but if left untreated can
result in cirrhosis, cancer, liver transplant and cardiovascular
disease. The prevalence of NASH 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 GENFIT
GENFIT is a late-stage biopharmaceutical company
dedicated to the discovery and development of innovative
therapeutic and diagnostic solutions in metabolic and liver related
diseases where there are considerable unmet medical needs,
corresponding to a lack of approved treatments. GENFIT is a leader
in the field of nuclear receptor-based drug discovery with a rich
history and strong scientific heritage spanning almost two decades.
Its most advanced drug candidate, elafibranor, is currently being
evaluated in a pivotal Phase 3 clinical trial (“RESOLVE-IT”) as a
potential treatment for NASH, and GENFIT plans to initiate a Phase
3 clinical trial in PBC next year following its positive Phase 2
results. As part of GENFIT’s comprehensive approach to clinical
management of patients with NASH, the company is also developing a
new, non-invasive and easy-to-access blood-based in vitro
diagnostic test to identify patients with NASH who may be
appropriate candidates for drug therapy. With facilities in Lille
and Paris, France, and Cambridge, MA, USA, the Company has
approximately 200 employees. GENFIT is a publically traded company
listed on the Nasdaq Global Select Market and in compartment B of
Euronext’s regulated market in Paris (Nasdaq and Euronext: GNFT).
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 statements about the Company’s expectations
for NIS4 regulatory filing submission, the potential of NIS4 to
provide a simple, non-invasive and cost-effective diagnostic tool
to all healthcare providers involved in the clinical management of
NASH patients and the initiation of a Phase 3 trial in PBC. The use
of certain words, including “believe,” “potential,” “expect” 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 related to safety, biomarkers, progression
of, and results from, its ongoing and planned clinical trials,
review and approvals by regulatory authorities of its drug and
diagnostic candidates and the Company’s continued ability to raise
capital to fund its development, as well as those risks and
uncertainties discussed or identified in the Company’s public
filings with the French Autorité des marchés financiers (“AMF”),
including those listed in Section 4 “Main Risks and Uncertainties”
of the Company’s 2018 Registration Document filed with the AMF on
February 27, 2019 under n° D.19-0078, which is available on
GENFIT’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 final prospectus dated March 26, 2019, and subsequent
filings and reports filed with the AMF or SEC, 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
Naomi EICHENBAUM – Investor Relations | Tel: +1
(617) 714 5252 | investors@genfit.com
PRESS RELATIONS | Media
Hélène LAVIN – Press relations | Tel: +333 2016
4000 | helene.lavin@genfit.com
GENFIT | 885 Avenue Eugène Avinée, 59120 Loos -
FRANCE | +333 2016 4000 |
www.genfit.com
1 Fibrosis-4
2 NAFLD Fibrosis Score
3 Enhanced Liver Fibrosis
- GENFIT Announces Results of NIS4, an Investigational
Non-Invasive NASH Diagnostic, at AASLD 2019