- 2 new ACLF clinical trials expected to initiate in
1Q25
- 3 clinical data readouts
expected by year-end 2025 across the ACLF pipeline, including
on-going UNVEIL-IT® Phase 2 trial
- Data of on-going Phase 1b
also expected by year-end 2025 for GNS561/trametinib in
KRAS-mutated cholangiocarcinoma, to support dose selection for
Phase 2
Lille (France), Cambridge (Massachusetts, United
States), Zurich (Switzerland), February 6,
2025 - GENFIT (Nasdaq and Euronext:
GNFT), a biopharmaceutical company dedicated to
improving the lives of patients with rare and life-threatening
liver diseases, today outlines the design of new clinical trials
within its Acute on-Chronic Liver Failure (ACLF) pipeline, with
several clinical data readouts by end of 2025.
Pascal Prigent, CEO of GENFIT,
commented: “Throughout 2024, our work in ACLF with leading academic
partners and real-world evidence from a dataset of over 270,000
U.S. patients provided valuable insights. This effort informed the
design of two new trials which are expected to initiate in the
first quarter with VS-01 and G1090N, the new formulation of NTZ. We
believe these designs will streamline execution and enable faster
patient recruitment. With the UNVEIL-IT®1 Phase 2 readout in ACLF
and the GNS561 Phase 1b readout in cholangiocarcinoma, we
anticipate four clinical data readouts by year-end, positioning
2025 as a pivotal year for GENFIT. Combined with our strengthened
financial outlook, announced last week and pending OCEANE
bondholders’ approval, GENFIT is well-positioned to operate on
strong foundations for the coming years.”
Evidence Supporting ACLF Pipeline Strategic
Development
New trials, set to launch, build on key 2024 findings from
complementary workstreams that provided a holistic understanding of
the ACLF continuum, including:
- Advanced
Real-World Evidence analysis: AI-driven evaluation of medical
claims data from over 270,000 U.S. patients, uncovering ACLF risk
profiles, referral dynamics, and management practices, including
patients with acute decompensation of cirrhosis (AD)
- KOL insights:
Key perspectives from the ACLF KOL Advisory Board held during the
November 2024 Liver Meeting2 in San Diego, including both U.S. and
European perspectives, with both NACSELD3 and EF CLIF4
stakeholders
- EF CLIF
collaboration: Ongoing engagement with our academic partner EF
CLIF, providing strategic insights into clinical management
practices and needs
- Learnings from
UNVEIL-IT®: Feedback from investigators on challenges and
opportunities
This integrated approach ensures a comprehensive foundation to
advance our ACLF pipeline. Notably, it has provided the rationale
for including a subset of patients with AD at a high-risk of
progressing to ACLF in our target population for the new trials.
Broadening inclusion criteria to cover the ACLF continuum creates
opportunities to address both stages of the disease. With easier
and faster identification, it will also enable a rapid assessment
of drug-candidates’ therapeutic potential, supporting data-driven
prioritization and minimizing the risk of engaging into
larger-scale investments.
Dr. Jonel Trebicka, MD, PHD, Head of Department and
Professor of Medicine, University of Münster, Germany,
commented: “It makes sense for GENFIT to evaluate its assets in a
subset of patients with AD having specific comorbidities that
contribute to a particularly poor prognosis. This category of
high-risk patients should be included in clinical trials given that
patients with AD transition rapidly to ACLF, and vice versa. AD and
ACLF are very dynamic syndromes sharing key pathophysiological
mechanisms.”
Dr. Jacqueline O’Leary, Chief of Hepatology at the
Dallas VA Medical Center and Professor of Medicine at UTSW,
USA, added: “ACLF should be viewed as a continuum.
Real-world evidence showed that some patients with acute
decompensation face a high risk of mortality. Therefore, it is
crucial to include this specific patient group when evaluating drug
candidates.”
2025 New Clinical Trial Initiations and
Readouts
The first trial to be launched is a proof-of-concept study that
underscores GENFIT’s commitment to VS-01:
- Target
population: patients with AD or ACLF grade 1 having overt Hepatic
Encephalopathy (HE) grades 2, 3 or 4, and ascites as a prerequisite
for drug administration
- Number of
patients: 21
- Treatment
duration: up to 4 days
- Primary
endpoint: Time to improvement in overt HE
- Secondary
endpoints: Safety and tolerability, pharmacokinetic and
pharmacodynamic parameters
- Exploratory
endpoints will include blood ammonia, inflammatory and other
clinical markers or outcomes
The second proof-of concept trial confirms
GENFIT’s commitment to NTZ, with G1090N, its new formulation
developed in 2024:
- Target
population: Patients with AD who are at risk of progression to ACLF
or ACLF grade 1
- Number of
patients: 21
- Treatment
duration: 7 days
- Primary
endpoint: Safety and tolerability
- Secondary
endpoint: Pharmacokinetic and pharmacodynamic parameters
- Exploratory
endpoints will include inflammatory and clinical markers or
outcomes
By design, these two new trials are not expected
to compete with the recruitment of patients for UNVEIL-IT®.
A third study, a First-in-Human trial with a new
formulation of SRT-015, is set to launch following final analyses
of preclinical data expected in 1Q25. Pending positive analysis,
pharmacokinetic and pharmacodynamic assessments will be conducted
in healthy volunteers, with clinical data readout anticipated by
late 2025.
With the readout of UNVEIL-IT® Phase 2, which
evaluates VS-01, also targeted in the second half of 2025, up to 4
clinical datasets are expected to be released by GENFIT before the
end of this year within our ACLF pipeline.
In addition, final data of the Phase 1b
evaluating GNS561 in combination with trametinib in patients with
KRAS-mutated cholangiocarcinoma, is also expected by year-end and
is aimed to support dose selection for Phase 2. Preliminary safety
data analyzed end of 2024 from the patients treated in the first
cohort of Phase 1b with the combination of GNS561 and trametinib
are supportive of the completion of the first cohort and of the
continuation of the study.
END
ABOUT GENFITGENFIT 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 aka G1090N,
SRT-015, CLM-022 and VS-02-HE, based on complementary mechanisms of
action using different routes of administration. Additional 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® (elafibranor5) 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 expected
timelines for research and development programs, impact of program
designs on ability and speed of recruiting patients into trials and
assessing potential of drug candidates therapeutic potential,
expectations regarding financial outlook. 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, pricing, approval and commercial success
of elafibranor in the relevant jurisdictions, 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, the Half-Year Business and Financial Report dated September
19, 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 inwhich 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 press release. 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 Iqirvo®, NIS2+® and UNVEIL-IT® are registered trademarks of
GENFIT SA2 The Liver Meeting 2024® is a registered trademark of the
American Association for the Study of Liver Diseases3 North
American Consortium for the Study of End-Stage Liver Disease4
European Foundation for the Study of Chronic Liver Failure5
Elafibranor is marketed and commercialized in the U.S by Ipsen
under the trademark Iqirvo®.
- GENFIT Outlines Anticipated New Clinical Trial Initiations,
Development Milestones and Data Readouts in 2025
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