GENFIT Announces FDA Grant of
Breakthrough Therapy Designation to Elafibranor for the Treatment
of PBC
- FDA grants elafibranor Breakthrough Therapy
Designation, based on Phase 2 data, for treatment of PBC (Primary
Biliary Cholangitis) in adults with inadequate response to
UDCA
- Breakthrough Therapy Designation follows Late Breaker
presentation of additional data from positive Phase 2
placebo-controlled trial evaluating elafibranor in PBC at EASL
International Liver Congress™ 2019, selected as “Best of ILC”
2019
Lille (France), Cambridge
(Massachusetts, United States), April 18, 2019 –
GENFIT (Nasdaq and 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 its lead
product candidate elafibranor was granted Breakthrough Therapy
Designation by the U.S. Food and Drug Administration (FDA) for the
treatment of Primary Biliary Cholangitis (PBC) in adults with
inadequate response to ursodeoxycholic acid (UDCA). Elafibranor is
a first-in-class double peroxisome proliferator-activated receptor
alpha and delta (PPAR alpha/delta) agonist which has produced
positive results in a Phase 2 clinical trial evaluating its safety
and efficacy in adults with PBC and inadequate response to UDCA.
Elafibranor is also currently evaluated in a Phase 3 clinical trial
in nonalcoholic steatohepatitis (NASH).
Breakthrough Therapy Designation is granted by
the FDA to expedite the development and review of drugs designed to
treat serious conditions for which preliminary data and evidence
indicate that the product candidate may demonstrate substantial
improvements over existing therapies on one or more clinically
significant endpoints.
GENFIT presented detailed results from its
positive Phase 2 clinical trial evaluating elafibranor in PBC
during the European Association for the Study of the Liver (EASL)
annual International Liver Congress™ (ILC). In a 12-week
double-blind randomized placebo-controlled Phase 2 trial of
non-cirrhotic patients with PBC and with inadequate response to
UDCA, elafibranor showed a significant decrease of alkaline
phosphatase (ALP) levels, resulting in significant treatment
effects versus placebo on the primary endpoint, whilst also meeting
the composite endpoint used for drug registration. In addition to
significant reductions in ALP, patients, in both
elafibranor-treated groups, showed improvements in other PBC
markers, including gamma-glutamyl transferase (GGT), lipid markers
(total cholesterol, LDL and triglycerides), and anti-inflammatory
markers (IgM, CRP, haptoglobin and fibrinogen). The improvement in
GGT, lipid and –anti-inflammatory markers is consistent with what
was observed in our Phase 2 clinical trial in NASH, and is
essential both for treating PBC and for treating a metabolic
disease like NASH. Treatment with both doses of elafibranor was
generally well-tolerated, and will be further evaluated for safety
and efficacy in a Phase 3 clinical trial expected to be initiated
in 2019.
Pascal Birman, Deputy Chief Medical
Officer of GENFIT, commented: “PBC is a severe liver
disease that can lead to cirrhosis and liver failure, and is
commonly associated with debilitating symptoms such as pruritus,
that affect patients’ quality of life. Approximately 50% of
patients have an inadequate response to existing therapies, either
because they do not respond to treatment or because they experience
intolerable side effects like aggravated pruritus (itching) or
hepatic toxicity. Elafibranor has shown promising anticholestatic
effects in a Phase 2 clinical trial, while showing a trend in
reducing pruritus. The FDA’s decision to grant elafibranor the
Breakthrough Therapy Designation on the basis of our Phase 2 data,
is of course a milestone that will allow us to accelerate
elafibranor’s development, and further confirms our strong belief
that elafibranor could potentially address this significant unmet
medical need.”
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). 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 rare liver disease.
ABOUT PBC
“PBC” is a chronic 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.
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 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 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 150 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- ISIN:
FR0004163111). 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 statements related to the development timeline
for elafibranor, the belief that elafibranor may be a safe and
effective treatment for NASH and PBC, timelines for the
commencement of clinical trials and the expected regulatory pathway
for elafibranor. 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
- 2019.04.17 - PR GENFIT - Breakthrough Designation PBC
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