- Trial
met primary endpoint with a statistically significant higher
percentage of patients achieving a clinically meaningful
cholestasis response compared to
placebo
-
Elafibranor was well tolerated with a safety profile
consistent with previous studies
- Results
position elafibranor as a potentially important new treatment
option, where there is still high unmet
need
- Ipsen
intends to submit regulatory applications for elafibranor following
discussions with the U.S. Food and Drug Administration
(FDA) and the European Medicines
Agency (EMA)
- GENFIT
conference call (English and French) on June
30 at 8am ET / 1pm GMT / 2pm CET
Paris
(France);
June
30,
2023 - Ipsen (Euronext:
IPN; ADR: IPSEY) and GENFIT
(Nasdaq and Euronext: GNFT) today announced positive
topline data from the pivotal ELATIVE® Phase III trial. In the
trial the efficacy and safety of elafibranor, an investigational
dual α,δ PPAR agonist, is being assessed for the treatment of
patients with the rare cholestatic liver disease, primary biliary
cholangitis (PBC), who have an inadequate response or intolerance
to the current standard of care therapy, ursodeoxycholic acid
(UDCA).
The trial met its primary composite endpoint,
with 51% of patients on elafibranor 80mg achieving a cholestasis
response compared with 4% on placebo (p<0.0001). Cholestasis
response is defined in the trial as alkaline phosphatase (ALP)
<1.67 x upper limit of normal (ULN), an ALP decrease ≥ 15
percent and total bilirubin (TB) ≤ ULN at 52 weeks. ALP and
bilirubin are important predictors of disease progression.
Reductions in levels of both can indicate reduced cholestatic
injury and improved liver function.
The first secondary endpoint, normalization of
ALP at Week 52, was also met with statistically significant
improvements for investigational elafibranor compared with placebo.
For the other secondary endpoint, a trend for pruritus improvement
was observed with a greater decrease from baseline in the PBC Worst
Itch NRS score for patients on elafibranor compared to placebo,
which did not reach statistical significance. In the study,
elafibranor was generally well tolerated with a safety profile
consistent with that observed in previously reported studies.
“These are encouraging results that suggest
elafibranor could be an effective treatment to prevent progression
of PBC in patients who have received UDCA. It has a good safety
profile and was well- tolerated, and could provide an important new
therapeutic option for long-term treatment of patients with this
debilitating condition,” said Howard Mayer, Executive Vice
President and Head of Research and Development for Ipsen.
“PBC is a serious condition which, if not treated properly, can
lead to progression of liver disease and ultimately liver failure.
We are excited about the potential of this investigational
treatment and Ipsen now intends to discuss these results with
regulatory agencies and plans to move forward with regulatory
submissions to the U.S. Food and Drug Administration and the
European Medicines Agency.”
“We are pleased by these results because PBC
remains a disease where significant unmet medical needs exist”,
added Pascal Prigent, Chief Executive Officer of
GENFIT. “This long-awaited trial outcome is therefore good
news for patients and for healthcare professionals who need more
options to improve the clinical management of patients with PBC. It
is also a gratifying recognition of the quality of our team’s work
and of GENFIT’s ability to innovate and deliver tangible
results.”
PBC is a rare, progressive, autoimmune
cholestatic liver disease1 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.1 Common symptoms of PBC
include fatigue and pruritus (itch), which can be severely
debilitating.1 Untreated, PBC can lead to liver failure, or in some
cases death. It is also a leading cause of liver transplantation.
It primarily affects middle-aged women, with nine women diagnosed
for every man. It is a disease where a significant proportion of
patients are unable to benefit from existing therapies. The
prevalence of people living with PBC is estimated to be between
23.9-39.2 per 100,000 in the U. S2 3and 22.27 per 100,000 in
Europe.4
ELATIVE® is a multi-center, randomized,
double-blind, placebo-controlled Phase III clinical trial, with an
open-label long-term extension (NCT03124108). ELATIVE® is
evaluating the efficacy and safety of elafibranor 80mg once daily
versus placebo for the treatment of patients with PBC with an
inadequate response or intolerance to UDCA, the existing first-line
therapy for PBC. The trial enrolled 161 patients who were
randomized 2:1 to receive elafibranor 80mg once daily or placebo.
Patients with an inadequate response to UDCA would continue to
receive UDCA in combination with elafibranor or placebo, while
patients unable to tolerate UDCA would receive only elafibranor or
placebo.
Full data from the ELATIVE® trial will be
presented at a future scientific congress.
GENFIT will host a conference call
on June
30,
2023 at
8:00am
ET /
1:00pm
GMT / 2:00pm CET in English and
in French
Both the English and French conference calls
will be accessible on the investor page of our website, under the
events section at https://ir.genfit.com/ or by calling 888-394-8218
(toll-free U.S. and Canada), 0800 279 0425 (toll-free UK) or 0805
101 219 (France) five minutes prior to the start time (confirmation
code: 6752821). A replay will be available shortly after the
call.
ABOUT ELAFIBRANOR
Elafibranor is a novel, oral, once-daily, dual
peroxisome activated receptor (PPAR) alpha/delta (α,δ) agonist,
currently under investigation as a treatment for patients with PBC,
a rare liver disease. In 2019, it was granted a Breakthrough
Therapy designation by the FDA in adults with PBC who have an
inadequate response to ursodeoxycholic acid (UDCA). Elafibranor has
not received approval by regulatory authorities anywhere in the
world.
ABOUT IPSEN
Ipsen is a global, mid-sized biopharmaceutical
company focused on transformative medicines in Oncology, Rare
Disease and Neuroscience. With total sales of €3.0bn in FY 2022,
Ipsen sells medicines in over 100 countries. Alongside its
external-innovation strategy, the Company’s research and
development efforts are focused on its innovative and
differentiated technological platforms located in the heart of
leading biotechnological and life-science hubs: Paris-Saclay,
France; Oxford, U.K.; Cambridge, U.S.; Shanghai, China. Ipsen has
around 5,400 colleagues worldwide and is listed in Paris (Euronext:
IPN) and in the U.S. through a Sponsored Level I American
Depositary Receipt program (ADR: IPSEY). For more information,
visit ipsen.com
ABOUT GENFIT
GENFIT is a late-stage biopharmaceutical company
dedicated to improving the lives of patients with rare and severe
liver diseases characterized by high unmet medical needs. GENFIT is
a pioneer in liver disease research and development with a rich
history and strong scientific heritage spanning more than two
decades. Thanks to its expertise in bringing early-stage assets
with high potential to late development and pre-commercialization
stages, today GENFIT boasts a growing and diversified pipeline of
innovative therapeutic and diagnostic solutions. Its R&D
pipeline covers six therapeutic areas via seven programs which
explore the potential of differentiated mechanisms of action,
across a variety of development stages (pre-clinical, Phase 1,
Phase 2, Phase 3). These diseases are acute on-chronic liver
failure (ACLF), hepatic encephalopathy (HE), cholangiocarcinoma
(CCA), urea cycle disorders (UCD), organic acidemias (OA) and
primary biliary cholangitis (PBC). Beyond therapeutics, GENFIT’s
pipeline also includes a diagnostic franchise focused on NASH and
ACLF. GENFIT has facilities in Lille and Paris (France), Zurich
(Switzerland) and Cambridge, MA (USA). GENFIT is a publicly traded
company listed on the Nasdaq Global Select Market and on
compartment B of Euronext’s regulated market in Paris (Nasdaq and
Euronext: GNFT). In 2021, IPSEN became one of GENFIT’s largest
shareholders and holds 8% of the company’s share capital. For more
information, visit www.genfit.com
IPSEN FORWARD LOOKING
STATEMENTS
The forward-looking statements, objectives and
targets contained herein are based on Ipsen’s management strategy,
current views and assumptions. Such statements involve known and
unknown risks and uncertainties that may cause actual results,
performance or events to differ materially from those anticipated
herein. All of the above risks could affect Ipsen’s future ability
to achieve its financial targets, which were set assuming
reasonable macroeconomic conditions based on the information
available today. Use of the words ‘believes’, ‘anticipates’ and
‘expects’ and similar expressions are intended to identify
forward-looking statements, including Ipsen’s expectations
regarding future events, including regulatory filings and
determinations. Moreover, the targets described in this document
were prepared without taking into account external-growth
assumptions and potential future acquisitions, which may alter
these parameters. These objectives are based on data and
assumptions regarded as reasonable by Ipsen. These targets depend
on conditions or facts likely to happen in the future, and not
exclusively on historical data. Actual results may depart
significantly from these targets given the occurrence of certain
risks and uncertainties, notably the fact that a promising medicine
in early development phase or clinical trial may end up never being
launched on the market or reaching its commercial targets, notably
for regulatory or competition reasons. Ipsen must face or might
face competition from generic medicine that might translate into a
loss of market share. Furthermore, the research and development
process involves several stages each of which involves the
substantial risk that Ipsen may fail to achieve its objectives and
be forced to abandon its efforts with regards to a medicine in
which it has invested significant sums. Therefore, Ipsen cannot be
certain that favorable results obtained during preclinical trials
will be confirmed subsequently during clinical trials, or that the
results of clinical trials will be sufficient to demonstrate the
safe and effective nature of the medicine concerned. There can be
no guarantees a medicine will receive the necessary regulatory
approvals or that the medicine will prove to be commercially
successful. If underlying assumptions prove inaccurate or risks or
uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements. Other risks
and uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including
interest rate and currency exchange rate fluctuations; the impact
of pharmaceutical industry regulation and healthcare legislation;
global trends toward healthcare cost containment; technological
advances, new medicine and patents attained by competitors;
challenges inherent in new-medicine development, including
obtaining regulatory approval; Ipsen's ability to accurately
predict future market conditions; manufacturing difficulties or
delays; financial instability of international economies and
sovereign risk; dependence on the effectiveness of Ipsen’s patents
and other protections for innovative medicines; and the exposure to
litigation, including patent litigation, and/or regulatory actions.
Ipsen also depends on third parties to develop and market some of
its medicines which could potentially generate substantial
royalties; these partners could behave in such ways which could
cause damage to Ipsen’s activities and financial results. Ipsen
cannot be certain that its partners will fulfil their obligations.
It might be unable to obtain any benefit from those agreements. A
default by any of Ipsen’s partners could generate lower revenues
than expected. Such situations could have a negative impact on
Ipsen’s business, financial position or performance. Ipsen
expressly disclaims any obligation or undertaking to update or
revise any forward-looking statements, targets or estimates
contained in this press release to reflect any change in events,
conditions, assumptions or circumstances on which any such
statements are based, unless so required by applicable law. Ipsen’s
business is subject to the risk factors outlined in its
registration documents filed with the French Autorité des Marchés
Financiers. The risks and uncertainties set out are not exhaustive
and the reader is advised to refer to Ipsen’s latest Universal
Registration Document, available on ipsen.com.
GENFIT FORWARD LOOKING
STATEMENTS
This press release contains certain
forward-looking statements with respect to GENFIT, including those
within the meaning of the Private Securities Litigation Reform Act
of 1995 in relation to the clinical performance of elafibranor in
the ELATIVE® Phase 3 clinical trial in PBC, plans to move forward
with regulatory authorities for potential approval of elafibranor
in PBC and our ability to accelerate our development. The use of
certain words, including “consider”, “contemplate”, “think”, “aim”,
“expect”, “understand”, “should”, “aspire”, “estimate”, “targeted”,
“anticipated”, “believe”, “wish”, “may”, “could”, “allow”, “seek”,
“encourage” or “have confidence” or (as the case may be) the
negative forms of such terms or any other variant of such terms or
other terms similar to them in meaning is intended to identify
forward-looking statements. Although the Company believes its
projections are based on reasonable expectations and 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 in relation to safety, biomarkers, cost of, progression
of, and results from, its ongoing and planned clinical trials,
review and approvals by regulatory authorities in the United
States, Europe and worldwide of our drug and diagnostic candidates,
potential commercial success of elafibranor if approved, exchange
rate fluctuations, potential synergies related to the acquisition
of Versantis, our capacity to integrate its assets, develop its
programs and our continued ability to raise capital to fund our
development, as well as those risks and uncertainties discussed or
identified in the Company’s public filings with the AMF, including
those listed in Chapter 2 “Main Risks and Uncertainties” of the
Company’s 2022 Universal Registration Document filed with the AMF
on April 18, 2023, which is available on the Company’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 2022 Annual
Report on Form 20-F filed with the SEC on April 18, 2023. 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.
IPSEN
CONTACTS
INVESTORSCraig Marks – Vice
President, Investor Relations | Tel: +44 7584 349 193
Nicolas Bogler – Investor Relations Manager |
Tel: +33 6 52 19 98 92
MEDIA
Anna Gibbins – Global Head of Franchise
Communications, Rare Disease | Tel: +44 7717801900
Ioana Piscociu – Senior Manager Global Media Relations | Tel: +
33 6 69 09 12 96
Amy Wolf – VP, Head of Corporate Brand Strategy &
Communications | Tel: 41 79 576 07 23
GENFIT
CONTACTS
INVESTORSJean-Christophe
Marcoux – Chief Corporate Affairs Officer | Tel: +33 3 2016 4000 |
jean-christophe.marcoux@genfit.com
MEDIAStephanie Boyer – Press
relations | Tel: +33 3 2016 4000 | stephanie.boyer@genfit.com
GENFIT | 885 Avenue Eugène Avinée, 59120 Loos -
FRANCE | +333 2016 4000 | www.genfit.com
1 Kimagi T, et al.. Orphanet J Rare Dis. 2008; 3:12 Lu et al.
Clinical Gastro and Hepatol 2018; 16:1342-13503 Galoosian et al.
Journal of Clinical and Transplantation Hepatology 2020; 8:49-604
Gazda J, et al. Can J GastroenterolHepatol. 2021 ; 915 -1525
- Ipsen and GENFIT Announce Positive Results from Phase III
ELATIVE® trial of elafibranor in patients with primary biliary
cholangitis, a rare cholestatic liver disease
Genfit (EU:GNFT)
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