GENFIT: Positive 42-month DSMB Recommendation for Continuation of
Phase 3 RESOLVE-IT Study of Elafibranor in NASH
GENFIT: Positive 42-month DSMB
Recommendation for Continuation of Phase 3 RESOLVE-IT Study of
Elafibranor in NASH
- Data Safety Monitoring Board (DSMB) recommends the
continuation of the RESOLVE-IT clinical trial without any
modifications, based on the pre-planned review of safety
data
- DSMB guidance remains consistent, supporting favorable
safety profile of elafibranor
Lille (France), Cambridge
(Massachusetts, United States), November 26, 2019 –
GENFIT (Euronext: GNFT – Nasdaq: 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 the Data
Safety Monitoring Board (DSMB) issued a positive recommendation for
the continuation, without any modifications, of the RESOLVE-IT
Phase 3 trial evaluating elafibranor in NASH.
The 42-month DSMB safety review supports
GENFIT’s continuation of the RESOLVE-IT study. This DSMB
recommendation marks the seventh review with no safety signals that
would justify modification or discontinuation of the study,
including review of safety data from patients in the study who have
received elafibranor for as long as three years.
Drugs such as elafibranor, a PPAR α/δ agonist,
and seladelpar, a PPAR δ agonist, target nuclear receptors, which
can exhibit variability in terms of safety, potency, and efficacy.
In trials with elafibranor to date, there have been no issues with
interface hepatitis. Elafibranor has achieved about 2000 collective
years of human exposure across its clinical development program in
Phases 1-3, and DSMB reviews of elafibranor safety and tolerability
data have supported continuation of the ongoing Phase 3 RESOLVE-IT
study without any modification.
This most recent DSMB recommendation supports
that elafibranor is generally safe and well tolerated in completed
and ongoing clinical studies, which is critical for drug candidates
that are aimed to treat chronic diseases such as NASH or PBC.
Top-line interim results from the Phase 3, RESOLVE-IT trial, based
on the primary endpoint of NASH resolution without worsening of
fibrosis, are expected to be announced in Q1 2020. If positive,
GENFIT aims to file a new drug application (NDA) with the U.S. Food
and Drug Administration (FDA) and the European Medicines Agency
(EMA) by the end of 2020. Elafibranor has received fast track
designation from the FDA for the treatment of NASH. If
approved, elafibranor could be the first approved therapy for
resolution of NASH without worsening of fibrosis.
“This seventh, favorable DSMB review is further
confirmation that our RESOLVE-IT trial can continue without
modification, keeping us on track for an NDA filing by the end of
2020. It strengthens our confidence that elafibranor is generally
safe and well tolerated, which is paramount for drugs that
are intended to treat a chronic and silent disease such as NASH. We
hold great hope for elafibranor based upon safety and efficacy data
in the GOLDEN-505 study and based upon available safety data from
the ongoing Phase 3 RESOLVE-IT trial, commented Dr. Carol Addy,
Chief Medical Officer at GENFIT. Taken together, this is supportive
of continuing with our Phase 3 RESOLVE-IT trial in NASH, initiating
our combination program in NASH to evaluate elafibranor when
administered with an SGLT2 inhibitor or a GLP-1 receptor agonist,
as well as the continuation of our therapeutic program in primary
biliary cholangitis (PBC).”
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 GENFIT believes, based
on clinical results to date, that elafibranor has the potential to
address multiple facets of NASH, including liver
inflammation/injury, insulin sensitivity, and lipid/metabolic
parameters. Phase 2 clinical trial results have also shown that
elafibranor may be an effective treatment for PBC, a chronic liver
disease. Elafibranor was granted a Breakthrough Therapy Designation
by FDA in this indication.
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 PBC
Primary biliary cholangitis (PBC) is a chronic,
autoimmune disease in which bile ducts in the liver are gradually
destroyed. The damage to bile ducts can inhibit the liver’s ability
to rid the body of toxins, and can lead to scarring of liver
tissue, known as cirrhosis. Elafibranor has shown promising results
for the treatment of PBC in a Phase 2 clinical trial, and was
granted the Breakthrough Therapy Designation by the FDA in this
indication.
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 in compartment B of Euronext’s regulated market
in Paris (Nasdaq and Euronext: GNFT). www.genfit.com
FORWARD LOOKING STATEMENTSThis
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
the potential of elafibranor to treat NASH and PBC, elafibranor’s
continued efficacy and safety profile, expectations
regarding the timing of release of top-line results from the Phase
3 RESOLVE-IT trial and of filing of new drug applications with
regulatory authorities, the potential of elafibranor to be the
first approved therapy for resolution of NASH without worsening of
fibrosis and the continuation of GENFIT’s other therapeutic
programs.TThe 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
- GENFIT: Positive 42-month DSMB Recommendation for Continuation
of Phase 3 RESOLVE-IT Study of Elafibranor in NASH
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