- Four poster presentations add to the evidence of the beneficial
effects of lanifibranor therapy on key components of NASH,
following further sub-analyses of Inventiva’s NATIVE Phase IIb
clinical trial results
- The fifth poster presentation demonstrates that lanifibranor
improves NASH, fibrosis and diastolic dysfunction in a hamster
model of diet-induced NASH and diastolic dysfunction
Daix (France), Long Island City (New York,
United States), October 18, 2021 – 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),
mucopolysaccharidoses (MPS) and other diseases with significant
unmet medical needs, today announced that five scientific abstracts
have been selected for poster presentations during the upcoming The
Liver Meeting™ 2021, organized by the American Association for the
Study of Liver Diseases (AASLD) on November 12-15, 2021.
The first abstract focuses on the improvement
of insulin resistance and the reversal to normoglycemia in patients
with non-cirrhotic NASH and prediabetes treated with
lanifibranor. Prediabetes, defined by fasting glucose levels,
is a risk factor for cardiovascular disease (CVD). Based on
Inventiva’s NATIVE Phase IIb clinical trial evaluating lanifibranor
in NASH, the authors show that markers of glucose metabolism
improved in patients with non-cirrhotic NASH and prediabetes during
treatment with lanifibranor.
The second abstract demonstrates the
beneficial effect of lanifibranor on the reduction of hepatic
steatosis and shows a correlation with markers of lipid and glucose
metabolism. The authors explain that, during the NATIVE Phase
IIb clinical trial, lanifibranor therapy induced a decrease of
steatosis, as measured by the Controlled Attenuation Parameter
(CAP, Fibroscan) method, consistent with the decrease of steatosis
observed with histological grading.
The third abstract highlights the correlation
between NASH resolution and fibrosis improvement following
lanifibranor treatment. The results from the NATIVE Phase IIb
clinical trial show that, following treatment at both doses of
lanifibranor (800mg/daily and 1200mg/daily), NASH resolution
responders were significantly more likely to also be fibrosis
improvers. Such correlation was also observed between ballooning
improvement and fibrosis improvement.
The fourth abstract focuses on the positive
effect of lanifibranor therapy in reducing Liver Sinusoidal
Endothelial Cell (LSEC) capillarization. Based on the results
of the NATIVE Phase IIb clinical trial, the authors analysed the
change in capillarization (measured by CD34 immunostaining) of LSEC
in patients with NASH and an activity >3 according to the
Steatosis Activity Fibrosis (SAF) score1. CD34 staining increased
with inflammation grade and fibrosis progression. Lanifibranor
showed a dose dependent reduction of CD34 staining which reached
significance in the periportal area.
The fifth abstract demonstrates that
lanifibranor improves NASH, fibrosis and diastolic dysfunction in a
hamster model of diet-induced NASH and diastolic dysfunction.
In a non-clinical study conducted in a hamster model of NASH and
diastolic dysfunction induced by a diet rich in fat, cholesterol
and fructose, the authors evaluated the effect of pan-PPAR agonist
lanifibranor. The results show that lanifibranor significantly
reduced lipids metabolism markers and reversed steatosis,
inflammation and fibrosis while significantly improving diastolic
dysfunction. This new data further supports the potential
development of lanifibranor as a treatment for NASH patients with
high risk of cardiovascular diseases.
These abstracts will be available for viewing by
attendees on the AASLD website and will also be featured in the
October supplement of the scientific journal Hepatology.
The details of the five poster presentations are
as follows:
Abstract #1:
Abstract title: |
"Lanifibranor reverses fasting glucose levels to normoglycemia in
prediabetic patients with nonalcoholic steatohepatitis (NASH)" |
Publication number: |
1920 |
Session title: |
NAFLD and NASH: Therapeutics - Pharmacologic and Other |
Author: |
Dr. Michael Cooreman, Chief Medical Officer of Inventiva |
Abstract #2:
Abstract title: |
"Lanifibranor treatment improves hepatic steatosis in patients with
NASH, evaluated by histological grading and Controlled Attenuation
Parameter (CAP)" |
Publication number: |
1921 |
Session title: |
NAFLD and NASH: Therapeutics - Pharmacologic and Other |
Author: |
Dr. Michael Cooreman, Chief Medical Officer of Inventiva |
Abstract #3:
Abstract title: |
"Treatment response to the PAN-PPAR agonist lanifibranor in the
NATIVE study: NASH resolution and fibrosis improvement are
correlated" |
Publication number: |
1938 |
Session title: |
NAFLD and NASH: Therapeutics - Pharmacologic and Other |
Author: |
Prof. Arun Sanyal, M.D., Virginia Commonwealth University and
co-principal investigator of Inventiva’s NATiV3 Phase III clinical
trial |
Abstract #4:
Abstract title: |
"Liver Sinusoidal Endothelial Cell (LSEC) capillarization in NASH
and its evolution following lanifibranor treatment: an exploratory
study of the NATIVE clinical trial" |
Publication number: |
1874 |
Session title: |
NAFLD and NASH: Experimental: Clinical |
Author: |
Prof. Pierre-Emmanuel Rautou, MD, PhD, Hopital Beaujon |
Abstract #5:
Abstract title: |
"Lanifibranor improves NASH, fibrosis and diastolic dysfunction in
a hamster preclinical model of diet induced NASH" |
Publication number: |
1919 |
Session title: |
NAFLD and NASH: Therapeutics - Pharmacologic and Other |
Presentation type: |
Poster
presentation |
Author: |
Guillaume Wettstein, Head of Pharmacology of Inventiva |
About the American Association for the Study of Liver
Diseases (AASLD)2
AASLD is the leading organization of scientists
and health care professionals committed to preventing and curing
liver disease. AASLD fosters research that leads to improved
treatment options for millions of liver disease patients. We
advance the science and practice of hepatology through educational
conferences, training programs, professional publications, and
partnerships with government agencies and sister societies.
About lanifibranor
Lanifibranor, Inventiva’s lead product
candidate, is an orally-available small molecule that acts to
induce anti-fibrotic, anti-inflammatory and beneficial vascular and
metabolic changes in the body by activating all three peroxisome
proliferator‑activated receptor (PPAR) isoforms, which are
well‑characterized nuclear receptor proteins that regulate gene
expression. Lanifibranor is a PPAR agonist that is designed to
target all three PPAR isoforms in a moderately potent manner, with
a well‑balanced activation of PPARα and PPARδ, and a partial
activation of PPARγ. While there are other PPAR agonists that
target only one or two PPAR isoforms for activation, lanifibranor
is the only pan‑PPAR agonist in clinical development for the
treatment of NASH. Inventiva believes that lanifibranor’s moderate
and balanced pan‑PPAR binding profile contributes to the favorable
tolerability profile that has been observed in clinical trials and
pre‑clinical studies to date. The FDA has granted Breakthrough
Therapy and Fast Track designation to lanifibranor for the
treatment of NASH.
About Inventiva
Inventiva is a clinical-stage biopharmaceutical
company focused on the development of oral small molecule therapies
for the treatment of NASH, MPS and other diseases with significant
unmet medical need.
Leveraging its expertise and experience in the
domain of compounds targeting nuclear receptors, transcription
factors and epigenetic modulation, Inventiva is currently advancing
two clinical candidates, as well as a deep pipeline of preclinical
programs.
Lanifibranor, its lead product candidate, is
being developed for the treatment of patients with NASH, a common
and progressive chronic liver disease for which there are currently
no approved therapies. In 2020, Inventiva announced positive
topline data from its Phase IIb clinical trial evaluating
lanifibranor for the treatment of patients with NASH and obtained
both FDA Breakthrough Therapy and Fast Track designation for
lanifibranor in the treatment of NASH. Lanifibranor is currently
being evaluated in a pivotal Phase III clinical trial.
Inventiva is also developing odiparcil, a second
clinical stage asset, for the treatment of patients with subtypes
of MPS, a group of rare genetic disorders. Inventiva announced
positive topline data from its Phase IIa clinical trial evaluating
odiparcil for the treatment of adult MPS VI patients in 2019 and
received both FDA Fast Track and Rare Paediatric Disease
designation for odiparcil in MPS VI.
In parallel, Inventiva is in the process of
selecting an oncology development candidate for its Hippo
signalling pathway program. Furthermore, the Company has
established a strategic collaboration with AbbVie in the area of
autoimmune diseases. AbbVie has started the clinical development of
ABBV‑157, a drug candidate for the treatment of moderate to severe
psoriasis resulting from its collaboration with Inventiva. This
collaboration enables Inventiva to receive milestone payments upon
the achievement of pre-clinical, clinical, regulatory and
commercial milestones, in addition to royalties on any approved
products resulting from the collaboration.
The Company has a scientific team of
approximately 70 people with deep expertise in the fields of
biology, medicinal and computational chemistry, pharmacokinetics
and pharmacology, as well as in clinical development. It also 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 GroupYannick Tetzlaff / 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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Important Notice
This press release contains forward-looking
statements, forecasts and estimates with respect to Inventiva’s
clinical trials, clinical trial data releases, clinical development
plans and anticipated future activities of Inventiva. Certain of
these statements, forecasts and estimates can be recognized by the
use of words such as, without limitation, “believes”,
“anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”,
“may”, “will” and “continue” and similar expressions. Such
statements are not historical facts but rather are statements of
future expectations and other forward-looking statements that are
based on management's beliefs. These statements reflect such views
and assumptions prevailing as of the date of the statements and
involve known and unknown risks and uncertainties that could cause
future results, performance or future events to differ materially
from those expressed or implied in such statements. Actual events
are difficult to predict and may depend upon factors that are
beyond Inventiva's control. There can be no guarantees with respect
to pipeline product candidates that the clinical trial results will
be available on their anticipated timeline, that future clinical
trials will be initiated as anticipated, or that candidates will
receive the necessary regulatory approvals. Actual results may turn
out to be materially different from the anticipated future results,
performance or achievements expressed or implied by such
statements, forecasts and estimates, due to a number of factors,
including that Inventiva is a clinical-stage company with no
approved products and no historical product revenues, Inventiva has
incurred significant losses since inception, Inventiva has a
limited operating history and has never generated any revenue from
product sales, Inventiva will require additional capital to finance
its operations, Inventiva's future success is dependent on the
successful clinical development, regulatory approval and subsequent
commercialization of current and any future product candidates,
preclinical studies or earlier clinical trials are not necessarily
predictive of future results and the results of Inventiva's
clinical trials may not support Inventiva's product candidate
claims, Inventiva may encounter substantial delays in its clinical
trials or Inventiva may fail to demonstrate safety and efficacy to
the satisfaction of applicable regulatory authorities, enrollment
and retention of patients in clinical trials is an expensive and
time-consuming process and could be made more difficult or rendered
impossible by multiple factors outside Inventiva's control,
Inventiva's product candidates may cause adverse drug reactions or
have other properties that could delay or prevent their regulatory
approval, or limit their commercial potential, Inventiva faces
substantial competition and Inventiva’s business, and preclinical
studies and clinical development programs and timelines, its
financial condition and results of operations could be materially
and adversely affected by the current COVID-19 pandemic. Given
these risks and uncertainties, no representations are made as to
the accuracy or fairness of such forward-looking statements,
forecasts and estimates. Furthermore, forward-looking statements,
forecasts and estimates only speak as of the date of this press
release. Readers are cautioned not to place undue reliance on any
of these forward-looking statements.
Please refer to the Universal Registration
Document for the year ended December 31, 2020 filed with the
Autorité des Marchés Financiers on March 15, 2021, the Annual
Report on Form 20-F for the year ended December 31, 2020 filed with
the Securities and Exchange Commission on March 15, 2021 as well as
the half-year financial report for the six months ended June 30,
2021 for additional information in relation to such factors, risks
and uncertainties.
Except as required by law, Inventiva has no
intention and is under no obligation to update or review the
forward-looking statements referred to above. Consequently,
Inventiva accepts no liability for any consequences arising from
the use of any of the above statements.
1 The SAF score combines assessments of hepatocellular
inflammation and ballooning.
2 https://www.aasld.org/
- Inventiva - PR - AASLD Abstract - EN - 05 18 2021
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