GENFIT: Major
Milestone for the RESOLVE-IT Phase 3 Trial on the Recruitment of
the Interim Analysis Cohort
-
Recruitment of the patient
cohort for accelerated approval has been reached
-
Interim baseline data on the
first 1,000 randomized patients shows good distribution of patient
recruitment worldwide
Lille (France),
Cambridge (Massachusetts, United States), April 11, 2018 -
GENFIT (Euronext: GNFT - ISIN: FR0004163111), a biopharmaceutical
company at the forefront of developing therapeutic and diagnostic
solutions in metabolic and inflammatory diseases, that notably
affect the liver or the gastrointestinal system, today announced
that the RESOLVE-IT trial in NASH and fibrosis has reached the
target recruitment for the interim cohort analysis.
GENFIT's phase 3 registration
trial RESOLVE-IT is an international study evaluating the efficacy
and safety of elafibranor 120mg once daily in patients with NASH
and fibrosis. The primary endpoint is the resolution of NASH
without worsening of fibrosis after 72 weeks of treatment.
The recruitment of the patients
needed for this analysis has been completed.
The analysis of this histological
endpoint will serve as the basis for accelerated approval under
Subpart H in the US and international market approval. The phase 3
will continue to enroll the full cohort for long term clinical
benefit analysis, based on progression to cirrhosis, mortality, and
liver-related outcomes.
The recruitment has also been
achieved for the exploratory arm of patients with F1 stage
fibrosis.
As initially announced, focus has
been made on the balanced distribution of treatments across all
sites and countries, based on stratification according to gender,
diabetes, and disease severity. In the international setting,
patients have been enrolled in more than 250 sites across North
America, Europe, Australia, Latin America, Turkey and South
Africa.
Interim baseline data on the first
1,000 randomized patients show that these NASH patients have
metabolic co-morbidities, with 48% having type 2 diabetes, 59%
having hypertension, and 51% having dyslipidemia. The average BMI
is 34. Hispanics represent 25% of the study population. The
baseline characteristics of the study population are in line with
the expected associated risk factors for NASH and fibrosis.
All these factors will contribute
to the robustness of the results, as the study encompasses data
from various regions, and allows for a good representation of
ethnicities.
Jean-François Mouney, Chairman & CEO of GENFIT,
commented: "We are very
pleased to announce that the RESOLVE-IT study has achieved the
recruitment goal for the interim cohort. We paid particular
attention to having the correct balance in the recruitment and
treatment allocation of patients, in order to comply with the
approved protocol design. We are confident that this phase 3
registration study has a great foundation for
delivering robust data, and in accordance with a real-life
setting."
About
elafibranor
Elafibranor is GENFIT's lead
pipeline product. Elafibranor is an oral once-daily administered
molecule, and a first-in-class compound 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.
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
GENFIT
GENFIT is a biopharmaceutical
company focused on the discovery and development of drug candidates
in areas of high unmet medical needs corresponding to a lack of
suitable treatment and an increasing number of patients worldwide.
GENFIT's R&D efforts are focused on bringing new medicines to
market for patients with metabolic, inflammatory, autoimmune and
fibrotic diseases, that affect the liver (such as NASH -
Nonalcoholic steatohepatitis) and more generally the
gastro-intestinal arena. GENFIT's approach combines novel
treatments and biomarkers. Its lead proprietary compound,
elafibranor, is currently in a Phase 3 study. With facilities in
Lille and Paris, France, and Cambridge, MA (USA), the Company has
approximately 130 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 of clinical data from, the RESOLVE-IT trial and the trial
of elafibranor in PBC, review and approvals by regulatory
authorities, such as the FDA or the EMA, regarding in particular,
elafibranor in NASH and PBC, as well as other drug candidates in
other indications and biomarkers candidates, the success of any
inlicensing 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 Chapter 7 of the 2017 Half Year Business and
Financial Report and under Section 4 "Main Risks and Uncertainties"
of the Company's 2016 Registration Document registered with the
French Autorité des marchés financiers on April 28, 2017 under n°
R.17-034, which is available on GENFIT's website (www.GENFIT.com)
and on the website of the AMF (www.amf-france.org). 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 | Jean-François Mouney
- Chairman & CEO | +333 2016 4000
PRESS RELATIONS | Ulysse
Communication - Bruno Arabian | +33 6 8788 4726
GENFIT | 885 Avenue Eugène
Avinée, 59120 Loos - FRANCE | +333 2016 4000 |
www.genfit.com
2018.04.11 PR GENFIT
RESOLVE-IT
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions 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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