- 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)
PARIS, FRANCE, 30
June 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.S2,3 and 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.
ENDS
About
elafibranorElafibranor 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 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
genfit.com
For further information:
Ipsen
Contacts Investors |
|
Craig
MarksVice President, Investor Relations+44 (0)7584 349 193
Nicolas Bogler Investor Relations
Manager+33 6 52 19 98 92 |
|
Media |
|
Anna
GibbinsGlobal Head of Franchise Communications,Rare
Disease+44 (0)7717801900 Amy WolfVP, Head
of Corporate Brand Strategy & Communications+41 79 576 07 23
|
Ioana
PiscociuSenior ManagerGlobal Media Relations+33 6 69 09 12
96 |
GENFIT contacts
GENFIT | Investors Tel: +33 3 2016 4000 |
Jean-Christophe Marcoux, Chief Corporate Affairs Officer |
jean-christophe.marcoux@genfit.com
PRESS RELATIONS | Media Stephanie Boyer – Press
relations | Tel: +33 3 2016 4000 | stephanie.boyer@genfit.com
Ipsen’s 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’s forward-looking
statementsThis 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.
References:
1. Kimagi T, et al.. Orphanet J Rare Dis. 2008;
3:1 2. Lu et al. Clinical Gastro and Hepatol 2018; 16:1342-1350 3.
Galoosian et al. Journal of Clinical and Transplantation Hepatology
2020; 8:49-604. Gazda J, et al. Can J GastroenterolHepatol.
2021 ; 915 -1525
- Ipsen PR_Phase III ELATIVE_30062023
Ipsen (EU:IPN)
Historical Stock Chart
Von Mär 2024 bis Apr 2024
Ipsen (EU:IPN)
Historical Stock Chart
Von Apr 2023 bis Apr 2024