Lille (France), Cambridge
(Massachusetts, United States), September
13,
2022 – GENFIT (Nasdaq and
Euronext: GNFT), a late-stage biopharmaceutical company
dedicated to improving the lives of patients with severe chronic
liver diseases, today announced that the U.S. Food and Drug
Administration (FDA) has granted Orphan Drug Designation to GNS5611
(ezurpimtrostat), a novel clinical-stage autophagy/PPT1 inhibitor,
for the treatment of cholangiocarcinoma.
Cholangiocarcinoma is a rare liver malignancy
with high mortality and limited treatment options. It occurs mostly
in people over the age of 50.
GNS561 (ezurpimtrostat) is a PPT-1 (Palmitoyl
Protein Thioesterase-1) inhibitor that blocks autophagy. Autophagy
is activated in tumor cells in response to certain conditions, due
to a tumor cell growth in advanced cancers. GNS561 has completed
pre-clinical studies and a Phase 1b trial confirming the rationale
for targeting cholangiocarcinoma. A Phase 2 trial is expected to
start in the fourth quarter 2022, with a first patient visit
expected in the first quarter 2023.
Dr Mark
Yarchoan, Associate Professor of
Oncology at John Hopkins
Medicine (Baltimore, MD)
commented: “Cholangiocarcinoma is a rare cancer with a high
mortality rate. Patients have limited treatment options,
particularly following first line therapy. This is why new
therapies are urgently needed and is one of the reasons that GNS561
was granted Orphan Drug Designation by the FDA. There is a real
path forward for new options for second line treatment in
cholangiocarcinoma, and GNS561 represents a strong second-line
therapy candidate and hope to patients.”
ABOUT GNS561
GNS561 is a PPT-1 (Palmitoyl Protein Thioesterase-1) inhibitor
that blocks autophagy. Autophagy is activated in tumor cells in
response to certain conditions, due to a tumor cell growth in
advanced cancers. One of the key cellular organs implicated in the
autophagy process is the lysosome. By entering the lysosomes and
binding to its target, GNS561 has an important inhibiting activity
on late-stage autophagy, which leads to tumor cell death.
ABOUT CHOLANGIOCARCINOMA
Cholangiocarcinoma is a type of cancer that
forms in the slender tubes (bile ducts) that carry the digestive
fluid bile. Cholangiocarcinoma occurs mostly in people over the age
of 50. Cholangiocarcinoma is divided into intrahepatic and
extrahepatic types based on where the disease occurs in the bile
ducts. Cholangiocarcinoma is often diagnosed when it is advanced,
making successful treatment difficult to achieve. Several risk
factors of chronic inflammatory damage and increased cellular
turnover have been established, such as primary sclerosing
cholangitis (a cholestatic liver disease), liver flukes, biliary
tract cysts, hepatolithiasis and toxins. Treatment options for
cholangiocarcinoma are limited and associated with high rates of
tumor recurrence, and short survival times.
ABOUT GENFIT
GENFIT is a late-stage biopharmaceutical company
dedicated to improving the lives of patients with severe chronic
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 a growing and diversified pipeline of
innovative therapeutic and diagnostic solutions.
Its R&D is focused on three franchises:
cholestatic diseases, Acute on Chronic Liver Failure (ACLF) and
NASH diagnostics. In its cholestatic diseases franchise, ELATIVE™,
a Phase 3 global trial evaluating elafibranor1 in patients with
Primary Biliary Cholangitis (PBC) is well underway following a
successful Phase 2 clinical trial. Topline data is expected to be
announced in the second quarter 2023. In 2021, GENFIT signed an
exclusive licensing agreement with IPSEN to develop, manufacture
and commercialize elafibranor in PBC and other indications. 2
GENFIT is also developing GNS5611 in cholangiocarcinoma following
the acquisition of exclusive rights in this indication from
Genoscience Pharma in 20213. In ACLF, a Phase 1 clinical program
with nitazoxanide has been initiated with data expected as early as
the third quarter 2022. As part of its diagnostic solutions
franchise, the Company entered into an agreement with Labcorp in
2021 to commercialize NASHnext®, powered by GENFIT’s proprietary
diagnostic technology NIS4® in identifying at-risk NASH.
GENFIT has facilities in Lille and Paris,
France, 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. 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, including statements regarding the timelines to start a
Phase 2 study of GNS561 in cholangiocarcinoma, the expected
timeline for first patient enrollment and the probability of
success of GNS561’s mechanism of action to address the unmet
medical need related to cholangiocarcinoma. The use of certain
words, including “consider”, “contemplate”, “think”, “aim”,
“expect”, “understand”, “should”, “aspire”, “estimate”, “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, progression of, and results from,
its ongoing and planned clinical trials, review and approvals by
regulatory authorities of its drug and diagnostic candidates, the
impact of the COVID-19 pandemic, exchange rate fluctuations 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 AMF, including
those listed in Chapter 2 “Main Risks and Uncertainties” of the
Company’s 2021 Universal Registration Document filed with the AMF
on 29 April 2022 under n° D.22-0400, 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 2021 Annual Report on Form 20-F filed with the SEC on
April 29, 2022. 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
PRESS RELATIONS | Media
Stephanie Boyer – Press relations | Tel: +333
2016 4000 | stephanie.boyer@genfit.com
GENFIT | 885 Avenue Eugène Avinée, 59120 Loos -
FRANCE | +333 2016 4000 | www.genfit.com
1 Elafibranor and GNS561 are investigational compounds that have
not been reviewed nor been approved by a regulatory authority2 With
the exception of China, Hong Kong, Taiwan, and Macau where Terns
Pharmaceuticals holds the exclusive license to develop and
commercialize elafibranor3 Agreement includes commercialization and
development in the United States, Canada and Europe, including the
United Kingdom and Switzerland
- FDA Grants GENFIT’s GNS561 Orphan Drug Designation for the
Treatment of Cholangiocarcinoma
Grafico Azioni Genfit (EU:GNFT)
Storico
Da Mar 2024 a Apr 2024
Grafico Azioni Genfit (EU:GNFT)
Storico
Da Apr 2023 a Apr 2024
