CORRECTION
GENFIT: Unblinding of Phase 3 RESOLVE-IT
Data Deferred
This release is being issued to correctly state
that the Phase 3 RESOLVE-IT trial remains blinded. This release
replaces the previously issued one in its entirety.
Lille (France), Cambridge
(Massachusetts, United States), February 20, 2020
– 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 that
unblinding of the Phase 3 RESOLVE-IT data will be delayed to
incorporate the latest FDA insights expected by the end of March.
Topline interim results will be announced in the weeks following
receipt of FDA insight.
This decision has been taken to ensure that the
latest thinking in the NASH field is properly captured so the
Company can optimize elafibranor’s NDA dossier at the time of
submission.
At this stage the trial remains blinded, meaning
this delay is not related to:
- concerns about elafibranor’s efficacy;
- safety or tolerability issues with elafibranor;
- corporate, legal, strategic or financial matters.
The final visit of the last patient for the
interim cohort to support accelerated marketing approval has been
completed on time, and the Phase 3 clinical trial RESOLVE-IT
database will be locked as planned, before the end of February.
ABOUT RESOLVE-IT
RESOLVE-IT is a phase 3 study evaluating the
efficacy and safety of elafibranor 120mg versus placebo in patients
with nonalcoholic steatohepatitis (NASH) and fibrosis. It is a
multicenter, randomized, double-blind, placebo-controlled study
with 2 arms. It is conducted under Subpart H (FDA) and conditional
approval (EMA). Treatment duration until interim analysis for
accelerated approval is 72 weeks.
ABOUT ELAFIBRANOR
Elafibranor, GENFIT’s lead pipeline therapeutic
candidate, has been developed to treat, in particular, nonalcoholic
steatohepatitis (NASH), for which it has been granted Fast Track
Designation by FDA. Elafibranor is an oral, once-daily,
first-in-class drug acting via dual agonism of peroxisome
proliferator-activated alpha/delta receptors.
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 an
increased risk of cardiovascular disease along with long-term risk
for progression to cirrhosis, leading to liver insufficiency and
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, and the need for liver
transplant. 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 of elafibranor in PBC in 2020, 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 blood-based diagnostic test,
NIS4, which, if approved, could enable easier identification of
patients with NASH. With facilities in Lille and Paris, France, and
Cambridge, MA, USA, the Company has approximately 200 employees.
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). 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 elafibranor’s potential to treat NASH and PBC,
elafibranor’s security and tolerability profile, Phase 3 RESOLVE-IT
clinical trial top line data publication calendar, GENFIT’s ability
to file and optimize an NDA dossier with regulatory authorities,
elafibranor’s potential to become the first approved drug for NASH
resolution without worsening of fibrosis, and the continuation of
GENFIT’s other therapeutic programs. The use of certain words,
including “believe,” “potential,” “expect” and “will”,
“provisional” 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
- 2020.02.20 GENFIT PR - FDA
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