GENFIT:
Launch of a U.S. Phase 2 investigator-initiated study with
nitazoxanide in patients with NASH-induced fibrosis
-
Phase 2 study targeting a
patient population with NASH-induced Stage 2 or 3
fibrosis
-
Anti-fibrotic effect of
nitazoxanide to be evaluated by several approaches including an
innovative method to quantify hepatic fibrogenesis flux
rates
Lille (France),
Cambridge (Massachusetts, United States), December 3, 2018 -
GENFIT (Euronext: GNFT - ISIN: FR0004163111), a biopharmaceutical
company focused on discovering and developing drug candidates and
diagnostic solutions targeting liver diseases, in particular those
of metabolic origin, and hepatobiliary diseases, today announced
the initiation of a Phase 2 proof-of-concept clinical trial
evaluating nitazoxanide (NTZ) in patients with non-alcoholic
steatohepatitis (NASH)-induced fibrosis, following submission of
the study protocol by Pinnacle Clinical Research to the U.S. Food
and Drug Administration (FDA).
Dr Stephen Harrison, Medical
Director of Pinnacle Clinical Research, San Antonio, Texas, USA,
Visiting Professor of Hepatology at the Radcliffe College of
Medicine, University of Oxford, will conduct this
investigator-initiated single-center, open-label trial to evaluate
the safety and efficacy of nitazoxanide in patients with
NASH-induced Stage 2 or Stage 3 fibrosis.
The objectives of this proof of
concept trial include evaluating the anti-fibrotic effect of
nitazoxanide by several approaches including an innovative method
to quantify hepatic fibrogenesis flux rates. Using heavy
water labeling, de novo collagen-associated
protein synthesis will be determined through Fractional Synthesis
Rate (FSR) of circulating proteins at baseline and at the end of
treatment to assess the effect of daily oral administration of
nitazoxanide. Other non-invasive methods including Magnetic
Resonance Elastography (MRE) and FibroScan® will be used to
evaluate the liver stiffness changes after nitazoxanide
treatment.
Nitazoxanide, currently marketed
and prescribed in the United States and other territories as an
anti-parasitic drug, was discovered by Genfit scientists to have
novel anti-fibrotic properties that were confirmed in preclinical
liver fibrosis models. Genfit presented the results of this
research in April 2017 at the European Association for the Study of
the Liver (EASL) International Liver Congress, supporting the
efficacy of nitazoxanide in two in vivo
disease models of liver fibrosis. Genfit observed that
administration of nitazoxanide significantly attenuated liver
fibrosis development. Additional preclinical data presented in
April 2018 at EASL on combination therapy with a low dose of
elafibranor and nitazoxanide indicate that nitazoxanide could be a
good candidate for combination therapy with elafibranor, in
addition to an anti-fibrotic monotherapy.
Genfit has been granted a U.S.
patent for use of nitazoxanide in NASH-induced liver fibrosis.
Dr Stephen
Harrison of Pinnacle Clinical Research stated: "Genfit's exciting discovery of the anti-fibrotic properties
of nitazoxanide in a preclinical model has the potential to bring a
new and interesting treatment option to NASH patients with
fibrosis. I look forward to seeing the results in patients and
contributing to Genfit's promising development plans for
nitazoxanide."
Jean-François
Mouney, Chairman and CEO of GENFIT added: "We
are pleased that this trial has been initiated, further
contributing to Genfit's pipeline of clinical stage programs. Dr.
Harrison is a world-renowned hepatologist and expert in NAFLD and
we are delighted that we can collaborate with him and Pinnacle
Clinical Research to perform this study in patients with high unmet
needs. We very much look forward to seeing the results of this
study which, if positive, will enable the further development of
nitazoxanide for the treatment of NASH patients both as a
monotherapy as well as in combination with elafibranor."
About
NASH
"NASH", or nonalcoholic
steatohepatitis, 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 progression
to liver cancer.
ABOUT PINNACLE
CLINICAL RESEARCH
Pinnacle Clinical Research is
dedicated to conducting late stage clinical trials in the areas of
hepatology and gastroenterology, with a special focus on fatty
liver disease. Pinnacle prides itself on conducting high-quality
research as a complement to the medical care that its volunteers
receive from their routine care center.
About
GENFIT
GENFIT is a biopharmaceutical
company focused on discovering and developing drug candidates and
diagnostic solutions targeting liver diseases, in particular those
of metabolic origin, and hepatobiliary diseases. GENFIT
concentrates its R&D efforts in areas of high unmet medical
needs corresponding to a lack of approved treatments. GENFIT's lead
proprietary compound, elafibranor, is a drug candidate currently
being evaluated in one of the most advanced Phase 3 studies
worldwide ("RESOLVE-IT") in nonalcoholic steatohepatitis (NASH),
considered by regulatory authorities as a medical emergency because
it is silent, with potentially severe consequences, and with a
prevalence on the rise. Elafibranor is also being evaluated in a
Phase 2 study in Primary Biliary Cholangitis (PBC), a rare liver
disease. As part of its comprehensive approach to clinical
management of NASH patients, GENFIT is conducting a discovery and
development program aimed at providing patients and physicians with
a non-invasive blood-based diagnostic test for NASH. With
facilities in Lille and Paris, France, and Cambridge, MA (USA), the
Company has approximately 150 employees. GENFIT is a public company
listed in compartment B of Euronext's regulated market in Paris
(Euronext: GNFT - ISIN: FR0004163111). www.genfit.com
FORWARD LOOKING
STATEMENT/DISCLAIMER
This press release contains
certain forward-looking statements. Although the Company believes
its expectations are based on reasonable assumptions, these
forward-looking statements are subject to numerous 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 biomarkers, progression of, and
results from, its ongoing and planned clinical trials, review and
approvals by regulatory authorities, such as the FDA or the EMA, of
its drug and diagnostic candidates, the success of any inlicensing
strategies, the ability of the Company to maintain, protect and
enhance its intellectual property rights in nitazoxanide without
infringing the rights of other companies, the Company's continued
ability to raise capital to fund its development, as well as those
discussed or identified in the Company's public filings with the
AMF, including those listed in Section 4 "Main Risks and
Uncertainties" of the Company's 2017 Registration Document
registered with the French Autorité des marchés financiers on April
27, 2018 under n° R.18-032, which is available on GENFIT's website
(www.genfit.com) and on the website of the AMF (www.amf-france.org)
and as updated by the 2018 Half Year Business and Financial Report
and available on the Investors page of GENFIT's website. Other than
as required by applicable law, the Company does not undertake any
obligation to update or revise any forward-looking information or
statements. This press release and the information contained herein
do not constitute an offer to sell or a solicitation of an offer to
buy or subscribe to shares in GENFIT in any country. This press
release has been prepared in both French and English. In the event
of any differences between the two texts, the French language
version shall supersede.
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
2018.12.03 - NTZ Launch - PR
EN
This
announcement is distributed by West Corporation on behalf of West
Corporation clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: GENFIT via Globenewswire
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