Inventiva announces three scientific presentations at the EASL
International Liver Congress™ 2022
- Three poster presentations showing
- the beneficial effects of lanifibranor on markers of
cardiometabolic health in patients with non-cirrhotic NASH fibrosis
independent of weight gain observed.
- the reduction of the FastTM score in association with the
beneficial effects of lanifibranor on liver histology and
biologically relevant biomarkers, in patients with NASH and F2/F3
fibrosis.
- the identification of biomarkers of histological response in
patients with non-cirrhotic NASH treated with lanifibranor.
Daix (France), Long Island City (New York,
United States), June 9, 2022 – 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 three
abstracts have been selected for poster presentation at the
upcoming International Liver Congress™ 2022 hosted by the European
Association for the Study of the Liver (EASL) on June 22-26, 2022
in London, UK.
The first abstract focuses on the beneficial
effects of lanifibranor on markers of cardiometabolic health in
patients with NASH showing that they are independent of weight
change. Based on the results of Inventiva’s NATIVE Phase IIb
clinical trial evaluating lanifibranor in NASH, the authors of the
abstract analysed markers of cardiometabolic health in relation
with the weight variation observed in patients treated with
lanifibranor or on placebo. The treatment with lanifibranor
showed beneficial effects on biomarkers of cardiometabolic health,
including markers of lipid and glucose metabolism, insulin
resistance and inflammation independent of weight change. These
beneficial effects occurred in parallel with an increase of
adiponectin levels demonstrating an improvement in adipose tissue
health. These results provide further evidence that PPARγ-induced
weight gain is associated with improved insulin sensitivity, i.e.
is metabolically healthy and thus distinct from lifestyle-related
weight gain.
The second abstract evaluates the beneficial
effect of lanifibranor treatment on the FibroScan-aspartate
aminotransferase (FastTM) score, a promising non-invasive test
(NIT) for active NASH with significant fibrosis. Based on the
data of the NATIVE trial, the authors evaluated the effect of
treatment with lanifibranor on the FastTM score,the correlation
between the histological and biomarker responses observed in
patients with NASH and fibrosis F2/F3. The data showed that the
treatment with lanifibranor induced a significant reduction of the
FastTM score compared to placebo. This reduction under lanifibranor
is associated with the histological endpoint ‘resolution of NASH
and improvement of fibrosis’, and with the improvement in
triglycerides, Apo-C3 and ferritin levels. These results highlight
the potential of the FastTM score as a NIT to monitor disease
progression and response to therapy.
The third abstract focuses on the
identification of biomarkers of histological response in patients
with non-cirrhotic NASH treated with lanifibranor. The
authors conducted an assessment of serum-based biomarkers from the
Inventiva’s NATIVE Phase IIb clinical trial in order to identify
biological signatures of the liver histological endpoints. The
authors identified four biomarkers: baseline levels of adiponectin
and ferritin, relative changes of MMP9 and transferrin at end of
treatment, which combined into a score could predict the ‘NASH
resolution and fibrosis improvement’ with a sensitivity of 70% and
specificity of 95%. Four different biomarkers were identified as
being predictive of the histological endpoint ‘NASH resolution
without worsening of fibrosis’: baseline CK18-M65, absolute change
of hyaluronate, relative changes of fructosamine and ALT at end of
treatment, with a sensitivity of 79% and specificity of 89%. This
exploratory assessment demonstrates that the combination of
biomarker signatures allowed a non-invasive identification of
histological response under lanifibranor treatment in NASH with a
good diagnostic performance.
The details of the various presentations are as
follows:
Abstract #1:
Abstract title: |
"The pan-PPAR agonist lanifibranor improves markers of
cardiometabolic health in patients with NASH independent of weight
change" |
Publication number: |
SAT119 |
Presentation type: |
Poster
presentation |
Authors: |
Michael P.
Cooreman, Sven Francque, Martine Baudin, Philippe Huot-Marchand,
Lucile Dzen, Jean-Louis Junien, Pierre Broqua, Manal F.
Abdelmalek |
Date: |
June 25, 2022 - 9:00am- 6:00pm (BST) |
Abstract #2:
Abstract title: |
"Lanifibranor
therapy reduces the FibroScan-aspartate aminotransferase (FastTM)
score associated with histological 'NASH resolution and improvement
of fibrosis' and biomarker response" |
Publication number: |
SAT120 |
Presentation type: |
Poster
presentation |
Authors: |
Michael P. Cooreman, Manal F. Abdelmalek, Martine Baudin, Philippe
Huot-Marchand, Lucile Dzen, Céline Fournier, Jean-Louis Junien,
Pierre Broqua, Sven Francque |
Date: |
June 25, 2022 - 9:00am- 6:00pm (BST) |
|
|
Abstract #3:
Abstract title: |
"Identification of biomarkers of histological response in patients
with non-cirrhotic NASH treated with Lanifibranor" |
Publication number: |
SAT105 |
Presentation type: |
Poster
presentation |
Authors: |
Jérôme Boursier, Hugo Hervé, Clémence Canivet, Marine Roux, Pierre
Broqua, Michael P. Cooreman, Jean-Louis Junien, Jean-Louis Abitbol,
Philippe Huot-Marchand, Lucile Dzen, Sanjaykumar Patel |
Date: |
June 25, 2022 - 9:00am- 6:00pm (BST) |
|
|
In addition, during the session « Critical
reflection on landmark papers », taking place Saturday, June
25th (10:00 to 11:30 – Capital Suite 12), Dr. Manal Abdelmalek will
present the results of the Phase IIb clinical trial with
lanifibranor: “A randomized, controlled trial of the pan-PPAR
agonist lanifibranor in NASH.”
Inventiva will also be present with a booth and
we are inviting you to visit us from Thursday, 23rd through
Saturday 25th, from 9:00 to 17:00 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 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’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.
The Company has established a strategic
collaboration with AbbVie in the area of autoimmune diseases that
resulted in the discovery of the drug candidate cedirogant
(ABBV-157), an oral RORγ inverse agonist which is being evaluated
in a Phase IIb clinical trial, led by AbbVie, in adult patients
with moderate to severe chronic plaque psoriasis. Inventiva’s
pipeline also includes odiparcil, a drug candidate for the
treatment of adult mucopolysaccharidoses (MPS) VI patients. As part
of Inventiva’s decision to focus clinical efforts on the
development of lanifibranor, it suspended clinical efforts relating
to odiparcil and is reviewing available options with respect to its
potential further development. Inventiva is in the process of
selecting an oncology development candidate for its Hippo signaling
pathway program.
The Company has a scientific team of
approximately 80 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 C 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
InventivaPascaline ClercVP of Global External Affairs
media@inventivapharma.com+1 240 620 9175 |
Brunswick GroupLaurence Frost / Tristan Roquet Montegon /
Aude LepreuxMedia relationsinventiva@brunswickgroup.com+33 1 53 96
83 83 |
Westwicke, an
ICR CompanyPatricia L. Bank Investor
relationspatti.bank@westwicke.com+1 415 513 1284 |
|
|
|
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- Inventiva - PR - EASL Abstracts - 06 09 2022
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