Genfit SA (GNFTF)

[Wildbilly]

GENFIT ANNOUNCES POSITIVE RESULTS FROM
PROPRIETARY NASH BIOMARKER PROGRAM

GENFIT has designed a diagnostic tool – as an alternative to
invasive liver biopsy – to identify NASH patients that deserve to
be treated, according to the consensual definition agreed
between experts and regulatory agencies.
? The diagnostic tool requires a simple blood sample and is based
on algorithms including a new type of NASH biomarkers:
circulating miRNAs.
? GENFIT has filed new patents and is building up a partnering
program to make a diagnosis kit available at the time of
commercialization of anti-NASH drugs.

Lille (France), Boston (Massachusetts, United States), September 15th
,
2015 – GENFIT (Euronext: GNFT; ISIN: FR0004163111), a biopharmaceutical
company at the forefront of developing therapeutic and diagnostic solutions in
metabolic and inflammatory diseases, that notably affect the liver or the
gastrointestinal system, today announces the development of a new reliable and
non-invasive diagnostic method, based on the measurement of a novel type of
blood biomarker: small non-coding RNA, or miRNA. The algorithm developed
enables the identification of NASH patients that should be treated with
Elafibranor (GFT505) or any other appropriate drug.
In terms of public health, the management of the NASH epidemic is a priority.
However, NASH is currently under-diagnosed since: i) NASH is a silent,
asymptomatic disease, ii) NASH diagnosis necessitates an invasive procedure,
the liver biopsy, that can only be performed by an experienced person, iii) there
is currently no approved medicine for this indication.
The efficient management of the NASH patient population thus requires new,
non-invasive, diagnostic tools, that are simple, rapid, reliable, and can be widely
distributed, in order to screen and detect NASH patients that should be treated.

GENFIT has launched an R&D initiative in the field of NASH diagnosis biomarkers
based on its expertise in transcriptomics applied to small circulating non-coding
RNAs, in particular miRNA.
GENFIT has constituted a large bank of plasma samples from NASH patients with
a liver biopsy. This patient cohort is extremely well-characterized (complete
anthropometric and biochemical data, centralized biopsy reading), and covers a
wide spectrum of NASH disease activity and severity.
After developing and validating a reliable method for the systematic
measurement of different miRNAs in the plasma, GENFIT has introduced these
measurements into the data set and challenged their diagnostic values versus
over 70 variables using two independent biostatistical approaches. Two methods
were used to generate thousands of cohorts from the initial patient population in
order to mimic real-life NASH variability and assure the translatability of the
results to the global NAFLD/NASH population. These parallel approaches
independently identified the same two specific miRNA species within the top 3
most powerful diagnostic markers of NASH. The two resulting algorithms
combine the identified miRNAs and known markers of liver damage. A
comparative study demonstrates that these algorithms are more powerful than
existing scoring systems for the identification of NASH patients that deserve to
be treated. New patent applications have been filed for the use of the
technologies developed by GENFIT for the diagnosis of NASH.
A new proprietary diagnostic tool will be used in the Phase 3 trial for Elafibranor.
Moreover, GENFIT has established international scientific collaborations to widen
its use in multiple cohorts of NASH patients. Finally, GENFIT is open to
partnerships with NASH and/or diagnostic stakeholder companies with the
objective of providing an FDA/EMA-approved NASH diagnosis kit available at the
time of drug commercialization.
Jean-François Mouney, Chairman and Chief Executive Officer of GENFIT,
declared: «For several years now, GENFIT has established an integrated R&D
strategy in NASH based on the parallel development of a non-invasive diagnostic
test and on the development of Elafibranor as a first-line medicine. After the
recent demonstration of the efficacy of Elafibranor for NASH treatment, today
we are announcing a new success in the NASH diagnostics field. We are thus
ideally positioned to meet the future medical and public health challenges linked
to the identification and management of millions of NASH patients.»


GENFIT has launched an R&D initiative in the field of NASH diagnosis biomarkers
based on its expertise in transcriptomics applied to small circulating non-coding
RNAs, in particular miRNA.
GENFIT has constituted a large bank of plasma samples from NASH patients with
a liver biopsy. This patient cohort is extremely well-characterized (complete
anthropometric and biochemical data, centralized biopsy reading), and covers a
wide spectrum of NASH disease activity and severity.
After developing and validating a reliable method for the systematic
measurement of different miRNAs in the plasma, GENFIT has introduced these
measurements into the data set and challenged their diagnostic values versus
over 70 variables using two independent biostatistical approaches. Two methods
were used to generate thousands of cohorts from the initial patient population in
order to mimic real-life NASH variability and assure the translatability of the
results to the global NAFLD/NASH population. These parallel approaches
independently identified the same two specific miRNA species within the top 3
most powerful diagnostic markers of NASH. The two resulting algorithms
combine the identified miRNAs and known markers of liver damage. A
comparative study demonstrates that these algorithms are more powerful than
existing scoring systems for the identification of NASH patients that deserve to
be treated. New patent applications have been filed for the use of the
technologies developed by GENFIT for the diagnosis of NASH.
A new proprietary diagnostic tool will be used in the Phase 3 trial for Elafibranor.
Moreover, GENFIT has established international scientific collaborations to widen
its use in multiple cohorts of NASH patients. Finally, GENFIT is open to
partnerships with NASH and/or diagnostic stakeholder companies with the
objective of providing an FDA/EMA-approved NASH diagnosis kit available at the
time of drug commercialization.
Jean-François Mouney, Chairman and Chief Executive Officer of GENFIT,
declared: «For several years now, GENFIT has established an integrated R&D
strategy in NASH based on the parallel development of a non-invasive diagnostic
test and on the development of Elafibranor as a first-line medicine. After the
recent demonstration of the efficacy of Elafibranor for NASH treatment, today
we are announcing a new success in the NASH diagnostics field. We are thus
ideally positioned to meet the future medical and public health challenges linked
to the identification and management of millions of NASH patients.»
Professor Arun Sanyal, Division of Gastroenterology, Hepatology and
Nutrition, Virginia Commonwealth University School of Medicine,
Richmond, VA, commented: «Circulating miRNAs undeniably represent a new
research domain for the development of novel diagnostic methods in numerous
chronic diseases and cancers. GENFIT’s algorithmic approach combining the
levels of specific miRNAs with other known markers of liver damage is extremely
promising. The results provide the proof of the added value of miRNAs as
diagnostic markers in NASH. They open the way to the development of a new
type of non-invasive diagnostic test for NASH.»

http://www.genfit.com/wp-content/uploads/2015/09/2015.09.15-PR-GENFIT-Biomarkers.pdf