- PBC program (licensed to
Ipsen):
- Ipsen to present new data
on elafibranor at The Liver Meeting® 2024
- Launch of Iqirvo®
(elafibranor)1 on track with
expectations; encouraging feedback from healthcare providers and
payers in the U.S.
- UK NICE reimbursement
approved and first reimbursed sales in Germany in October
2024
- Next €26.5M milestone
payment by Ipsen pending a third pricing and reimbursement approval
in Europe
- Scientific progress in ACLF
to be featured at The Liver Meeting® 2024, with 4 posters
presenting new preclinical data, and 3 events bringing together key
ACLF stakeholders
- Results from UNVEIL-IT®
Phase 2 trial evaluating VS-01 in ACLF now expected in 2H25;
protocol modified to improve recruitment and trial
design
- New insights and emerging
scientific trends incorporated into our ACLF development plan, with
data readout from 4 clinical trials anticipated by the end of 2025,
including data from 3 new clinical trials to be launched in 1H25,
in addition to UNVEIL-IT®
Lille (France), Cambridge
(Massachusetts, United States), Zurich (Switzerland), November 13,
2024 - GENFIT (Nasdaq and Euronext:
GNFT), a late-stage biopharmaceutical company dedicated to
improving the lives of patients with rare and life-threatening
liver diseases, today provided a corporate update ahead of The
Liver Meeting 2024®2.
Pascal Prigent, CEO of GENFIT
said: “We are thrilled to see that Ipsen continues to execute as
planned and make great progress with elafibranor, on both
commercial and regulatory fronts in the U.S. and Europe, further
enhancing our financial outlook for the rest of this year and
beyond. We continue to build on our momentum in Acute on-Chronic
Liver Failure (ACLF), where we plan to initiate multiple clinical
studies in 2025 and report Phase 2 UNVEIL-IT® data from our VS-01
program. We recently updated the Phase 2 UNVEIL-IT® study protocol
to improve trial enrollment and worked with centers to address
logistical hurdles associated with the use of new technology. We
are very confident that with these changes, along with supporting
several exciting initiatives that will help better identify
patients that are particularly at risk, we have taken the right
steps to put GENFIT in a strong position to advance this program
forward for patients.”
I. Positive momentum for the Primary
Biliary Cholangitis (PBC) program
Ipsen recently reported positive commercial and
regulatory developments with Iqirvo®3 in the U.S. and Europe 4
5:
- U.S. launch progress is on-track
after June 10, 2024 U.S. Food and Drug Administration approval
following priority review6
- Ipsen received EMA7 approval on
September 20, 2024 and the UK MHRA8 approval on October 9, 2024
followed by UK NICE9 approval on October 22, 2024
- Recent reimbursement in Germany and
the UK brings GENFIT closer to a €26.5M milestone payment, pending
a third pricing and reimbursement approval in a major European
country
II. Strategic developments across the
ACLF franchise
GENFIT at The Liver Meeting
2024
GENFIT will present pre-clinical data as part of
its ACLF franchise with the following posters:
- VS-01: Effect of
VS-01 on Acute-on-Chronic Liver failure-related toxins such as
lipopolysaccharide and hydrophobic bile acids in vitro (poster
#1603)
- SRT-015:
Intravenous administration with the ASK1 inhibitor SRT-015
alleviates liver injury and systemic inflammation in disease models
of liver failure (poster #1597)
- CLM-022:
Investigational drug CLM-022, a potent inhibitor of NLRP3
inflammasome-mediated pyroptosis, as a potential treatment for
acute and chronic inflammatory liver diseases (poster #2232)
- NTZ: Efficacy of
Nitazoxanide (NTZ) in Pathogen-Associated Molecular Patterns
(PAMPs)-induced disease models (poster #2222)
GENFIT will also lead 3 key events on ACLF:
- ACLF KOL Advisory
Board (November 14, 2024), bringing together 9 leading
experts from Europe and the United States
- ACLF Patient Advocacy
Council (November 16, 2024), with the participation of
Professor Debbie Shawcross, MBBS PhD FRCP, Professor of Hepatology
and Chronic Liver Failure, Institute of Liver Studies King’s
College London, UK and EASL Vice-Secretary), the Global Liver
Institute (GLI), the European Liver Patients’ Association (ELPA),
and real-life patients and caregivers
- ACLF Morning
Insights session (November 17, 2024), focused on
addressing unmet needs, diagnostics, and guidelines for ACLF, with
Dr. Jasmohan Bajaj, Professor of Medicine in the Division of
Gastroenterology, Hepatology and Nutrition at Virginia Commonwealth
University and Richmond VA Medical Center in Richmond, Virginia,
USA. The event will also offer an intensivist’s perspective with
Dr. William Bernal, Professor of Liver Critical Care Medicine in
the Liver Intensive Therapy Unit at the Institute of Liver Studies
at King’s College Hospital, London and Member of the EASL-CLIF
Consortium Steering Committee. It will also outline GENFIT’s
clinical roadmap and highlight the patient and caregiver
experience, via GLI and ELPA.
Key strategic insights and emerging
trends uncovered through unique sources and channels
Over the last 12 months, GENFIT has made strides
in understanding the ACLF continuum, enriching our body of
knowledge compared to the knowledge available in the field at the
time of our pivot to ACLF.
Key takeaways derived from these workstreams
will inform the design of on-going and upcoming trials evaluating
VS-01, NTZ and SRT-015. These insights will also help further
strategize the research and clinical development of CLM-022 and
VS-02-HE.
-
UNVEIL-IT®3 clinical and
operational improvements: As announced in September
202410, lower than expected trial enrollment prompted a protocol
amendment to better accommodate patient care logistics and
comorbidities. These recent modifications require time before they
can be implemented in every investigational site and before they
can significantly impact the enrollment curve. Therefore, we are
now guiding 2H25 for UNVEIL-IT results. The two main points of
focus for our improvement efforts have been:
- Inclusion and exclusion criteria
were overly restrictive for a patient population with multiple
co-morbidities. As we accumulated data to better characterize these
patients, we collaborated with investigators and KOLs to modify the
protocol and better address the targeted
population.
- Logistical challenges are inherent
to the introduction of any new technology. In the case of VS-01 the
necessary steps in the reconstitution process, and the limitation
of a clinical trial setting, had previously restricted patient
enrollment windows. By generating additional stability data, we now
offer enhanced storage flexibility for study material, enabling
clinical trial centers to use VS-01 more frequently. Additionally,
we have been working on the development of an innovative medical
device which should be available next year and will further
streamline the reconstitution process.
- Cutting-edge processing of
Real-World Evidence: An in-depth analysis of medical
claims data – leveraged through advanced A.I. and machine learning
techniques from a targeted U.S. population of over 270,000
patients – provided pivotal insights into risk profiles
within specific patient sub-populations of the ACLF continuum, as
well as differences in referral dynamics, patient journeys and
clinical management practices compared to Europe. Applying
sophisticated algorithms uncovered epidemiological patterns and
trends within this substantial dataset, generating actionable
intelligence that enhances our understanding and supports more
precise, data-driven decisions across our portfolio.
- Preclinical
research: New preclinical models have been established
with leading experts, serving as key enablers to deliver valuable
data aimed at improving our understanding of our portfolio
potential. To date, the data already generated encompasses a range
of disease models and various formulations. This approach is
designed to optimize asset positioning and refine population
targeting, ultimately supporting strategic decision-making and
maximizing impact across our therapeutic landscape.
- Collaboration with learned
societies: Strategic partnerships, including with the
European Foundation for the Study of Chronic Liver Failure (EF
CLIF) and engagement with U.S. KOLs from NACSELD11, offered
important insights through unique data sources encompassing several
observational studies, while also accelerating and expanding
discussions with key leaders in the field. This type of
collaboration places GENFIT at the forefront of international
research, advancing the understanding of ACLF pathophysiology and
uncovering novel approaches for the treatment of this
syndrome.
Data readout from 4 clinical trials
anticipated by the end of 2025
Building on insights from the upcoming KOL
Advisory Board and additional real-world evidence anticipated by
late November 2024, GENFIT will finalize the design of two new
proof-of-concept studies evaluating VS-01 and NTZ, alongside a
First-in-Human study for SRT-015 with GENFIT’s formulation. These
trials are expected to launch in the first half of 2025, with data
readouts expected by year-end.
With Phase 2 data for UNVEIL-IT trial also
anticipated by the close of 2025, GENFIT will deliver four clinical
data sets in 2025, advancing three clinical-stage assets of our
ACLF pipeline in parallel.
Preclinical assets
- CLM-022:
Preclinical Proof of Concept expected to be obtained by end of
2024
- VS-02-HE:
Completion of Investigational New Drug (IND) enabling studies
expected in 2025
III. GNS561 in KRAS-mutated
cholangiocarcinoma
The phase 1b/2a clinical trial is currently
ongoing and preliminary data from Phase 1b is targeted by the end
of 2024. Final data is expected by the end of 2025.
IV. NIS2+® in MASH
During The Liver Meeting 2024, GENFIT will also
present new data on NIS2+®’s3 efficacy as a monitoring tool for
patients with MASH12 with the following posters:
- NIS2+, an effective monitoring tool
for tracking disease evolution in patients with fibrotic MASH
(poster #2062)
- NIS2+, an effective tool for
monitoring MASH resolution and fibrosis improvement in patients
with at-risk MASH (poster #2063)
- Detecting MASH resolution and
fibrosis improvement with NIS2+ in patients with at-risk MASH
(poster #2067)
Significant progress has been made since the
recognition of NIS2+ as a key tool for detecting at-risk MASH in
June 202413, as our technology is now also covering screening and
monitoring needs, and not just diagnostics needs. With more than 20
clinical MASH trials using our technology, more publications are
referring to it, highlighting the relevance of our solution. In
March 2024, Rezdiffra™ (resmetirom) was the first drug approved in
MASH in the United States. As a reminder, GENFIT signed a
commercial agreement with Labcorp in 2021 to provide broad clinical
availability of the test to specialty and primary care physicians
across the U.S. and Canada. Our business goal is now to develop an
IVD version of the test, either in collaboration with a commercial
partner or by ourselves.
ABOUT GENFIT
GENFIT is a late-stage biopharmaceutical company
committed to improving the lives of patients with rare,
life-threatening liver diseases whose medical needs remain largely
unmet. GENFIT is a pioneer in liver disease research and
development with a rich history and a solid scientific heritage
spanning more than two decades. Today, GENFIT has built up a
diversified and rapidly expanding R&D portfolio of programs at
various stages of development. The Company focuses on
Acute-on-Chronic Liver Failure (ACLF). Its ACLF franchise includes
five assets under development: VS-01, NTZ, SRT-015, CLM-022 and
VS-02-HE, based on complementary mechanisms of action using
different routes of administration. Other assets target other
serious diseases, such as cholangiocarcinoma (CCA), urea cycle
disorder (UCD) and organic acidemia (OA). GENFIT's expertise in the
development of high-potential molecules from early to advanced
stages, and in pre-commercialization, was demonstrated in the
accelerated approval of Iqirvo® (elafibranor) by the U.S. Food and
Drug Administration, the European Medicines Agency and the
Medicines and Healthcare Regulatory Agency in the UK for Primary
Biliary Cholangitis (PBC). Beyond therapies, GENFIT also has a
diagnostic franchise including NIS2+® in Metabolic
dysfunction-associated steatohepatitis (MASH, formerly known as
NASH for non-alcoholic steatohepatitis) and TS-01 focusing on blood
ammonia levels. GENFIT is headquartered in Lille, France and has
offices in Paris (France), Zurich (Switzerland) and Cambridge, MA
(USA). The Company is listed on the Nasdaq Global Select Market and
on the Euronext regulated market in Paris, Compartment B (Nasdaq
and Euronext: GNFT). In 2021, Ipsen became one of GENFIT's largest
shareholders, acquiring an 8% stake in the Company's capital.
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, but not limited to statements about ability
to receive upcoming milestone payments from Ipsen pursuant to our
Licensing and Collaboration agreement and the effect of Ipsen
commercial performance on our financial outlook, availability and
timing of results of our UNVEIL-IT clinical trial in ACLF as well
as four additional clinical programs, and the impact of changes to
the UNVEIL-IT clinical trial protocol on improving trial enrollment
and the timing and impact of development of a new medical device
for VS-01 reconstitution. The use of certain words, such as
"believe", "potential", "expect", “target”, “may”, “will”,
"should", "could", "if" 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 others, the uncertainties inherent in
research and development, including in relation to safety of drug
candidates, cost of, progression of, and results from, our 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, 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 "Risk Factors and Internal Control" of the Company's 2023
Universal Registration Document filed on April 5, 2024 (no.
D.24-0246) with the Autorité des marchés financiers ("AMF"), which
is available on GENFIT's website (www.genfit.fr) and the AMF's
website (www.amf.org), and those discussed in the public documents
and reports filed with the U.S. Securities and Exchange Commission
("SEC"), including the Company’s 2023 Annual Report on Form 20-F
filed with the SEC on April 5, 2024 and subsequent filings and
reports filed with the AMF or SEC or otherwise made public, by the
Company. In addition, even if the results, performance, financial
position and liquidity of the Company 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.
CONTACTS
GENFIT | Investors
Tel: +33 3 2016 4000 | investors@genfit.com
GENFIT | Media
Stephanie Boyer – Press relations | Tel: +333
2016 4000 | stephanie.boyer@genfit.com
GENFIT | 885 Avenue Eugène Avinée, 59120 Loos -
FRANCE | +333 2016 4000 |
www.genfit.com
1 Elafibranor is marketed and commercialized by Ipsen under the
trademark Iqirvo®2 The Liver Meeting 2024® is a registered
trademark of the American Association for the Study of Liver
Diseases3 Iqirvo®, NIS2+® and UNVEIL-IT® are registered trademarks
of GENFIT SA4
https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2024/10/24164500/Ipsen-YTD-2024-sales-presentation-1.pdf5
https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2024/10/24164500/Ipsen-YTD-2024-sales-presentation-1.pdf6
https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2024/10/24164500/Ipsen-YTD-2024-sales-presentation-1.pdf7
European Medicines Agency8 Medicines and Healthcare products
Regulatory Agency9 UK National Institute for Health and Care
Excellence10
https://ir.genfit.com/news-releases/news-release-details/genfit-reports-first-half-year-2024-financial-results-and11
North American Consortium for the Study of End-Stage Liver
Disease12 Metabolic dysfunction-associated steatohepatitis13
https://ir.genfit.com/news-releases/news-release-details/genfit-new-easl-easd-easo-clinical-practice-guidelines-masld
- GENFIT Announces Corporate Updates and Upcoming Participation
at The Liver Meeting® 2024
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