Inventiva announces five scientific presentations at the EASL
International Liver Congress™ 2023
- Five poster presentations showing :
- the correlation between the improvement of hepatic steatosis
and a robust increase in adiponectin levels, improvement in lipid
profile and glycemic control in patients with non-cirrhotic NASH
treated with lanifibranor.
- the Early improvement in ALT or AST being predictive of
response pattern of liver histology as well as non-invasive hepatic
and cardiometabolic biomarkers observed after 24-week treatment
with lanifibranor in patients with non-cirrhotic NASH.
- the improvement of portal hypertension and splanchnic
circulation independently of fibrosis reduction and metabolic
improvement following lanifibranor treatment in a mouse model of
prehepatic portal hypertension.
- the reduction of the increased portal pressure and improvement
of steatosis in a rat model of early NAFLD following a 4-week
lanifibranor treatment.
- the greater reduction of the increased portal pressure
associated with early NAFLD following lanifibranor treatment
compared to the PPAR agonists α, δ or γ individually.
Daix (France), Long Island City (New
York, United States), June 7, 2023 – Inventiva
(Euronext Paris and Nasdaq: IVA), a clinical-stage
biopharmaceutical company focused on the development of oral small
molecule therapies for the treatment of non-alcoholic
steatohepatitis (NASH) and other diseases with significant unmet
medical needs, today announced that five abstracts have been
selected for poster presentation at the upcoming International
Liver Congress™ 2023 hosted by the European Association for the
Study of the Liver (EASL) on June 21-24, 2023 in Vienna,
Austria.
The first abstract evaluates the
correlation between severity and improvement of hepatic steatosis,
adiponectin response, and improvement of markers of cardiometabolic
health following a 24 weeks treatment with lanifibranor.
Based on the results of Inventiva’s NATIVE Phase IIb clinical trial
evaluating lanifibranor in NASH, the authors analysed the
correlation between the biomarkers of cardiometabolic health and
hepatic steatosis, which is a marker of cardiovascular risk,
in patients who were randomized to lanifibranor or placebo.
The hepatic steatosis was measured by histological grading
and by imaging using Controlled Attenuation Parameter (“CAPTM”)
Fibroscan®. As previously shown, treatment with lanifibranor
improved the hepatic steatosis and the biomarkers of
cardiometabolic health, including adiponectin, insulin resistance
and markers of lipid and glucose metabolism. In this analysis,
these beneficial cardiometabolic effects were shown to be
correlated with an improvement in steatosis both measured
histologically and using CAP.
The second abstract focuses on the
identification of non-invasive tests as potential predictor tools
of histological response or non-response to lanifibranor.
Based on the data of the NATIVE trial, the authors evaluated the
ability early improvements in aminotransferase levels measured
after a 4-week treatment with lanifibranor to predict the
histological non-responses to treatment evaluated at 24 weeks. The
results demonstrated that in patients with NASH treated with
lanifibranor, the absence of a 15% reduction in alanine
aminotransferase (“ALT”) levels after 4 weeks of treatment was an
effective tool to predict non-response on histological NASH
resolution. In addition, the early decrease in ALT and aspartate
aminotransferase (“AST”) after 4 weeks of treatment with
lanifibranor, correlated with an improvement of non-invasive
hepatic biomarkers and markers of cardiometabolic health observed
after 24 weeks of treatment with lanifibranor.
The third abstract evaluates the effect
of lanifibranor on the portal pressure in models of hepatic and
prehapetic portal hypertension. Given that portal
hypertension (“PHT”) can cause severe complications in patients
with advanced chronic liver disease (“ACLD”), the authors evaluated
the effect of a daily treatment with lanifibranor on portal
hypertension in two mice models of portal hypertension. They
demonstrated that lanifibranor reduced the portal pressure
independently of fibrosis reduction or of an effect on metabolism,
but through the reduction of the venous mesenteric vascular
expansion and splanchnic angiogenesis, and an amelioration of the
liver sinusoidal endothelial cells.
The fourth abstract evaluates the effect
of lanifibranor on portal pressure, endothelial dysfunction and
liver histology in a rat model of early NAFLD. The authors
demonstrated that in an early NAFLD-induced rat model without
inflammation or fibrosis, lanifibranor treatment completely
normalized the portal pressure and the trans-hepatic pressure
gradient. In addition lanifibranor improved the hyperreactivity to
the vasoconstrictor methoxamine and the hyporeactivity to the
vasodilator acetylcholine in the NAFLD-induced rat model. In
parallel, the authors also demonstrated the reduction of steatosis
evaluated histologically, although not sufficient to explain the
observed vascular effects.
The fifth abstract compares the effect
of each individual PPAR isotopes α, δ and γ to the
pan-PPAR lanifibranor on the improvements of the vascular
alterations and histology in a NAFLD-induced rat model.
The authors demonstrated that in a rat model of early NAFLD with
steatosis but no inflammation or fibrosis, treatment with
Fenofibrate (PPAR-alpha agonist), GW501516 (PPAR-delta agonist) and
Rosiglitazone (PPAR-gamma) decreased the portal pressure and the
transhepatic pressure gradient with a limited effect on the hepatic
steatosis. The improvements on the vascular function were more
pronounced with lanifibranor than with each individual PPAR
agonist. These data suggest that there is an additive effect of
combined PPAR agonists compared to mono-agonist leading to an
greater improvement of the vascular alterations in early NAFLD.
The details of the various presentations are as
follows:
Abstract #1:
Abstract title: |
"Correlation between severity of hepatic steatosis and markers of
cardiometabolic health, and effect of lanifibranor therapy in
patients with non-cirrhotic NASH" |
Abstract identifier: |
FRI-517 |
Presentation type: |
Poster
presentation |
Authors: |
Michael P
Cooreman, Sven Francque, Philippe Huot-Marchant, Lucile Dzen,
Martine Baudin, Jean-Louis Junien, Pierre Broqua, Manal F
Abdelmalek |
Date: |
June 23, 2023 – 9:00-18:00 (CEST) |
Abstract
#2:
Abstract title: |
"Early
aminotransferase improvement in the phase 2b NATIVE study is
predictive of response pattern of liver histology as well as
hepatic and cardiometabolic health markers at the end of treatment
in patients with non-cirrhotic NASH" |
Abstract identifier: |
SAT-393 |
Presentation type: |
Poster
presentation |
Authors: |
Quentin M Anstee, Philippe Huot-Marchand, Lucile Dzen, Jean-Louis
Junien, Pierre Broqua, Sven Francque, Manal F Abdelmalek, Michael P
Cooreman, Stephen A Harrison |
Date: |
June 24, 2023 – 9:00-17:00 (CEST) |
|
|
Abstract #3:
Abstract title: |
"The pan-PPAR agonist lanifibranor decreases portal pressure in
models of both hepatic and prehepatic portal hypertension" |
Abstract identifier: |
THU-361 |
Presentation type: |
Poster
presentation |
Authors: |
Anneleen Heldens, Christophe Casteleyn, Louis Onghena, Milton
Baoheng Antwi, Benedicte Descamps, Christian Vanhove, Xavier
Verhelst, Hans Van Vlierberghe, Lindsey Devisscher, Jean-Louis
Junien, Anja Geerts, Guillaume Wettstein, Sander Lefere |
Date: |
June 22, 2023 – 9:00-18:30 (CEST) |
Abstract #4:
Abstract title: |
"The pan-PPAR agonist Lanifibranor improves increased portal
pressure, endothelial dysfunction and liver histology in a rat
model of early NAFLD" |
Abstract identifier: |
WED-466 |
Presentation type: |
Poster presentation |
Authors: |
Shivani Chotkoe, Yao Liu, Guillaume Wettstein, Jean-Louis Junien,
Luisa Vonghia, Hannah Ceuleers, Joris De Man, Benedicte De Winter,
Wilhelmus J. Kwanten, Sven Francque |
Date: |
June 21, 2023 – 9:00-18:00 (CEST) |
Abstract #5:
Abstract title: |
"Unraveling the individual contributions of the PPAR isotypes to
the pan-PPAR agonist Lanifibranorinduced improvements of the
vascular alterations and liver histology in a rat model of early
NAFLD" |
Abstract identifier: |
WED-523 |
Presentation type: |
Poster presentation |
Authors: |
Shivani Chotkoe, Yao Liu, Guillaume Wettstein, Jean-Louis Junien,
Luisa Vonghia, Hannah Ceuleers, Joris De Man, Benedicte De Winter,
Wilhelmus J. Kwanten, Sven Francque |
Date: |
June 21, 2023 – 9:00-18:00 (CEST) |
Inventiva will also be present with a booth and
we are inviting you to visit us from Wednesday, June 21st until
Saturday, June 24th at booth #19 located
in the exhibition hall 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 NASH,
mucopolysaccharidoses (“MPS”) 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 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 an oncology development 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
Contacts
Inventiva Pascaline ClercVP of Global External
Affairsmedia@inventivapharma.com +1 240 620
9175 |
Brunswick GroupTristan Roquet Montegon /Aude
Lepreux /Matthieu BenoistMedia
relationsinventiva@brunswickgroup.com +33 1 53 96 83
83 |
Westwicke, an ICR CompanyPatricia L. BankInvestor
relationspatti.bank@westwicke.com
+1 415 513-1284 |
Important Notice
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clinical trial with lanifibranor in NASH and the LEGEND Phase IIa
combination trial with lanifibranor and empagliflozin in patients
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- Inventiva - PR - EASL Abstracts - EN - 06 07 2023
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