* The first abstract demonstrates that the improvements of MACK-3, a
diagnostic test for metabolic dysfunction-associated steatohepatitis,
parallel the histological response to lanifibranor therapy in patients with
MASH/NASH, in the NATIVE Phase IIb clinical trial.
* The second abstract brings additional evidence supporting the role of
intrahepatic vascular alterations in the development of MASLD-related portal
hypertension and the progression to MASH and highlights the potential of
lanifibranor in addressing the different components of MASH disease
including vascular alterations.
Daix (France), Long Island City (New York, United States), May 22, 2024 -
Inventiva (Euronext Paris and Nasdaq: IVA), a clinical-stage biopharmaceutical
company focused on the development of oral small molecule therapies for the
treatment of metabolic dysfunction-associated steatohepatitis ("MASH"), also
known as non-alcoholic steatohepatitis ("NASH"), and other diseases with
significant unmet medical needs, today announced that two scientific abstracts
have been selected for poster presentation at the upcoming International Liver
Congress(TM) 2024 hosted by the European Association for the Study of the Liver
(EASL) on June 5-8, 2024 in Milan, Italy.
The first abstract evaluates the correlation of the response of the biomarker
algorithm MACK-3 with the improvement of liver histology as well as markers of
cardiometabolic health with lanifibranor treatment. MACK-3 is composed of HOMA-
IR, AST and CK-18 and has been validated against histology as a diagnostic
marker for active MASH/NASH with fibrosis. The authors demonstrated that the
decrease in MACK-3 value at the end of a 24 week-treatment period was
significantly higher among the patients treated with lanifibranor which were
qualified as responders for the histological endpoints of "MASH/NASH resolution
and fibrosis improvement", "Fibrosis improvement without worsening of MASH/NASH"
and "MASH/NASH resolution without fibrosis worsening, compared to patients
treated with lanifibranor but qualified as non-responders for the endpoints.
Similar results were observed for improvement of NAS, SAF, and individual liver
lesions: steatosis, lobular inflammation, and ballooning. MACK-3 improvement
correlated as well as with increase of adiponectin levels and decrease of Pro-
C3, a circulating marker of fibrogenesis, following therapy with lanifibranor.
These results warrant additional study to evaluate MACK-3 as a potential marker
for the evaluation of a treatment response to lanifibranor.
The second abstract evaluates the effect of the pan-PPAR agonist, lanifibranor,
on the improvement of liver histology as well as vascular alterations in a model
of early MASLD. An increase in intrahepatic vascular resistance related to
endothelial dysfunction in MASLD can be a potential driver of disease
progression. The authors demonstrated that in a model of early MASLD,
lanifibranor improved steatosis, normalized the mean arterial blood pressure,
strongly decreased the portal pressure in-vivo and normalized the transhepatic
pressure gradient ex-vivo. Furthermore, lanifibranor also decreased the
reactivity to the vasoconstrictor methoxamine and normalized the hyporeactivity
to vasodilator acetylcholine. The results from the collaboration between the
University of Antwerp and Inventiva support the role of intrahepatic vascular
alterations in the development of MASLD-related portal hypertension as well as
in the progression to MASH and highlight the potential of lanifibranor in
addressing all the components of MASH disease.
The details of the presentations are as follows:
Abstracts :
"Improvements in MACK-3, a diagnostic test for active
metabolic dysfunction-associated steatohepatitis, parallel
Abstract #1 title: response to lanifibranor therapy"
Poster identifier: SAT-206
Presentation type: Poster presentation
Michael P Cooreman, Sven Francque, Philippe Huot-Marchant,
Lucile Dzen, Martine Baudin, Jean-Louis Junien, Pierre
Authors: Broqua, Manal F Abdelmalek, Jérôme Boursier
Date: Saturday June 8, 2024 - 8:30-17:00 (CEST)
"Altered liver vascular biology occurring in early stages
of metabolic dysfunction-associated steatotic liver disease
is significantly improved by the pan-peroxisome
proliferator-activated receptor agonist lanifibranor,
Abstract #2 title: associating with improved liver histology"
Poster identifier: THU-258-YI
Presentation type: Poster presentation
Shivani Chotkoe, Guillaume Wettstein, Jean-Louis Junien,
Luisa Vonghia, Denise van der Graaff, Joris De Man,
Authors: Benedicte De Winter, Wilhelmus J. Kwanten, Sven Francque
Date: Thursday 6, 2024 - 8:30-17:00 (CEST)
Inventiva will also be present with a booth, and we are inviting you to visit us
from Wednesday, June 5(th) until Saturday, June 8(th) at booth #N4 located in
the exhibition hall 3 of the conference center.
About Inventiva
Inventiva is a clinical-stage biopharmaceutical company focused on the research
and development of oral small molecule therapies for the treatment of patients
with MASH/NASH and other diseases with significant unmet medical need. The
Company benefits from a strong expertise and experience in the domain of
compounds targeting nuclear receptors, transcription factors and epigenetic
modulation. Inventiva is currently advancing one clinical candidate, has a
pipeline of two preclinical programs and continues to explore other development
opportunities to add to its pipeline.
Inventiva's lead product candidate, lanifibranor, is currently in a pivotal
Phase III clinical trial, NATiV3, for the treatment of adult patients with
MASH/NASH, a common and progressive chronic liver disease for which there are
currently no approved therapies.
Inventiva's pipeline also includes odiparcil, a drug candidate for the treatment
of adult MPS VI patients. As part of Inventiva's decision to focus clinical
efforts on the development of lanifibranor, it suspended its clinical efforts
relating to odiparcil and is reviewing available options with respect to its
potential further development. Inventiva is also in the process of selecting a
candidate for its Hippo signaling pathway program.
The Company has a scientific team of approximately 90 people with deep expertise
in the fields of biology, medicinal and computational chemistry,
pharmacokinetics and pharmacology, and clinical development. It owns an
extensive library of approximately 240,000 pharmacologically relevant molecules,
approximately 60% of which are proprietary, as well as a wholly-owned research
and development facility.
Inventiva is a public company listed on compartment B of the regulated market of
Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global Market
in the United States (ticker: IVA). www.inventivapharma.com
(http://www.inventivapharma.com/)
Contacts
Brunswick Group
Tristan Roquet Montegon Westwicke, an ICR
Inventiva / Company
Aude Lepreux / Patricia L. Bank
Pascaline Clerc Matthieu Benoist Investor relations
EVP, Strategy and Media relations patti.bank@westwicke.c
Corporate Affairs inventiva@brunswickgroup om
media@inventivapha .com (mailto:patti.bank@wes
rma.com (mailto:inventiva@brunsw twicke.com)
(mailto:media@inve ickgroup.com)
ntivapharma.com)
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