GENFIT: Positive
30-month DSMB Recommendation for Continuation of Phase 3 RESOLVE-IT
Study of Elafibranor in NASH
-
Data Safety Monitoring Board
(DSMB) recommended the continuation of RESOLVE-IT without any
modifications, based on the pre-planned review of safety data,
including adverse events and laboratory data
-
Positive recommendation
consistent with previous observations supporting the favorable
safety profile of elafibranor
-
Top line data expected by the
end of 2019
Lille (France), Cambridge (Massachusetts, United States), December
17, 2018 - GENFIT (Euronext: GNFT - ISIN: FR0004163111), 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 DSMB
issued a new positive recommendation for the continuation of the
RESOLVE-IT Phase 3 trial evaluating elafibranor in nonalcoholic
steatohepatitis (NASH) without any modification. This new
pre-planned review of the DSMB did not identify any safety
concerns.
As NASH is considered a chronic
condition, safety is crucial for any drug candidate that aims to
address the unmet clinical needs related to this pathology.
The positive DSMB safety review
enables GENFIT to move forward as planned, with the RESOLVE-IT
study. The Phase 3 trial has already completed recruitment of the
cohort needed for the interim analysis. GENFIT expects to report
top line data by the end of 2019, a year expected to be pivotal for
the NASH space. These results, if positive, would support
accelerated approval from the U.S. Food and Drug Administration, or
FDA, and conditional approval from the European Medicines Agency,
or EMA, as early as 2020. Elafibranor has received fast track
designation from the FDA for the treatment of NASH.
Dr Pascal Birman,
Deputy Chief Medical Officer of GENFIT, commented: "NASH is considered a chronic condition and therefore a
favorable safety profile is crucial for any drug candidate aiming
to address the unmet clinical needs related to this pathology.
Safety is indeed an essential requirement for
regulatory authorities like the FDA and EMA, and will also be
scrutinized by payers. This positive DSMB review gives us
confidence as we move toward completion of the first treatment
period."
About
elafibranor
Elafibranor is GENFIT's lead
pipeline product. Elafibranor is being developed as an oral
once-daily treatment, and a first-in-class drug acting via dual
peroxisome proliferator-activated alpha/delta pathways developed to
treat, in particular, nonalcoholic steatohepatitis (NASH).
Elafibranor is believed to address multiple facets of NASH,
including inflammation, insulin sensitivity, lipid/metabolic
profile, and liver markers. Elafibranor also presents a
particularly interesting profile to potentially treat PBC, a
serious chronic liver disease.
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
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 - state where liver function
is diminished, leading to liver insufficiency - and to liver
cancer. Patients are also exposed to an aggravated cardiovascular
risk, and CVD is the leading cause of death in this population.
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 has also obtained positive
results in a Phase 2 clinical trial in Primary Biliary Cholangitis
(PBC), a chronic liver disease. As part of its comprehensive
approach to clinical management of NASH patients, GENFIT is
conducting an ambitious discovery and development program aimed at
providing patients and physicians with a blood-based test for the
diagnosis of NASH, i.e. non-invasive and easy-to-access. 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 safety, biomarkers, progression
of, and results from, its ongoing and planned clinical trials,
including its RESOLVE-IT Phase 3 trial, review and approvals by
regulatory authorities, such as the FDA or the EMA, of its drug and
diagnostic candidates, the success of any in-licensing strategies,
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
12.17.2018 - DSMB RESOLVE-IT 30
months
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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