GENFIT Launches a Phase 2 Trial
Evaluating Elafibranor on Hepatic Lipid Composition for
NAFL
- Study objective to determine the effect of elafibranor,
a dual PPAR alpha/delta agonist, on fatty acid saturation
- Phase 2 study to evaluate the effect of a 6-week, once
daily treatment of elafibranor (120mg) vs. placebo on hepatic lipid
composition in patients with Nonalcoholic Fatty Liver
(NAFL)
- State of the art non invasive techniques (H-MRS) to be
used to provide indications on both quantitative and qualitative
evolution of liver fat
Lille (France), Cambridge
(Massachusetts, United States), June 04, 2019 –
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 the launch of
a P2 clinical trial evaluating elafibranor’s activity on liver fat
quantity and – most importantly – fat composition in nonalcoholic
fatty liver disease (NAFLD) patients.
NAFLD is a common disorder referring to a
condition associated with an accumulation of fat in the liver.
Although persistent fat in the liver is common and can remain
static, NAFLD is known to be a precursor for a much more serious
condition, non-alcoholic steatohepatitis or NASH, which is
associated with liver cell damage, inflammation, and scarring of
the liver, and potentially severe outcomes including cardiovascular
events, cirrhosis, liver failure or liver cancer. The composition
of hepatic lipids is altered in NASH, especially in patients with
diabetes, where polyunsaturated fatty acids are more prominent and
give rise to toxic lipid species, such as ceramides. It is
therefore crucial for NASH-targeted drugs to preferentially
eliminate lipid species that are substrates for toxic lipid
production.
The phase 2 is a randomized, placebo-controlled,
double-blind, cross-over study in sixteen patients with NAFL as
identified with magnetic resonance spectroscopy (H-MRS). The
primary objective will evaluate the effects of treatment with
elafibranor (120mg/daily) for 6-weeks vs. placebo on changes in
hepatic lipid composition in subjects with fatty liver. Secondary
measurements include impact on hepatic glucose production (HGP),
glucose homeostasis, lipid metabolism, inflammatory markers and
liver function, as well as safety. The trial will be conducted in
The Netherlands.
Elafibranor, a PPAR alpha/delta agonist, is
currently the only late-stage, Phase 3 (RESOLVE-IT) therapy
undergoing investigation for “NASH resolution without the worsening
of fibrosis” (approved regulatory endpoint for Phase 3 trials), and
could be the first therapy able to eliminate the underlying cause
of NASH disease progression. The results from the P2b GOLDEN trial
showed elafibranor’s unique ability to address NASH resolution, and
beneficial effects on cardiometabolic lipids (LDL decrease, HDL
increase, and TG decrease), glucose metabolism (HbA1c,
HOMA-IR, FPG, FFA, C-peptide), in addition to a favorable safety
and tolerability profile. Therefore, elafibranor’s superior,
pluripotent mechanism of a PPAR alpha and delta, could be
beneficial by improving quantity and quality of fat in the liver,
specifically targeting the more harmful, lipotoxic fat subtypes
that buildup in NAFLD and drive progression to NASH.
Dean Hum, Chief Operating Officer and
Chief Scientific Officer at GENFIT said: “From GENFIT’s
twenty years of research, we have seen that the synergistic
combination of PPAR alpha and delta results in a pleiotropic impact
resulting in benefits for many of the characteristics of NAFL and
NASH. The significant benefit is due largely to the pluripotent
effects on the disease cascade, including driving on-target liver
directed activity at the hepatocyte level, providing increased
oxidation of fatty acids, thereby reducing the injury to the liver.
The reduction of fat has shown significant benefit in NAFL, and in
certain patients, prevents the progression to NASH. Assessing liver
fat with non-invasive tools is helpful in understanding the way in
which elafibranor’s mechanism positively affects the fat
composition, specifically, fatty acid saturation.”
Pr Vlad Ratziu, Hepatologist, Hôpital
Universitaire Pitié Salpêtrière, Paris, added: ”One of the
greatest challenges for NAFL patients is understanding the
underlying drivers that cause progression to NASH. The data GENFIT
will generate from this trial will be supportive for defining the
relationship between different types of lipids and their roles.
MRI-PDFF is an informative tool used to address fat quantity, but
is still unable to differentiate between saturated and unsaturated
fatty acids, all which produce different pathophysiological
outcomes. This is why using H-MRS is important to gain precious
insights on the quality of intrahepatic fat. With that said, it’s
also important to remember that ballooning and inflammation remain
the only NASH lesions recognized by regulators in Phase 3
trials.”
ABOUT ELAFIBRANOR
Elafibranor is GENFIT’s lead pipeline product
candidate. Elafibranor is an oral, once-daily, first-in-class drug
acting via dual peroxisome proliferator-activated alpha/delta
pathways developed to treat, in particular, nonalcoholic
steatohepatitis (NASH), for which it has been granted Fast Track
Designation. GENFIT believes, based on clinical results to date,
that elafibranor has the potential to address multiple facets of
NASH, including inflammation, insulin sensitivity, lipid/metabolic
profile, and liver markers. Phase 2 clinical trial results have
also shown that elafibranor may be an effective treatment for PBC,
a severe liver disease. Elafibranor was granted a Breakthrough
Therapy Designation in this indication.
ABOUT NASHNASH 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 failure, and also progression to liver cancer.
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 in PBC later this year following its positive
Phase 2 results. As part of GENFIT’s comprehensive approach to
clinical management of NASH patients, the company is also
developing a new, non-invasive and easy-to-access blood-based in
vitro diagnostic test to identify patients with NASH who may be
appropriate candidates for drug therapy. With facilities in Lille
and Paris, France, and Cambridge, MA, USA, the Company has
approximately 160 employees. GENFIT is a public 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 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 the potential benefits of evaluating
elafibranor’s effect on hepatic fat composition, on the ability of
elafibranor to eliminate the underlying cause of NASH disease
progression and its potential to be approved for the treatment of
NASH and the timing thereof, by regulatory authorities. The 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
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