Daix (France), Long Island City (New York, United States), June 24, 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 the abstract "Lanifibranor
Improves Markers of Cardiometabolic Health in Patients with NASH and Type 2
Diabetes, Correlated With Responses in Adiponectin Levels" has been selected for
poster presentation during the American Diabetes Association's 83(r)(d)
Scientific Sessions taking place on June 23-26, 202 in San Diego, United States.
Adiponectin plays a critical role in energy homeostatis by regulating insulin
sensitivity, lipid metabolism and control of glycemia. In addition adiponectin
has anti-inflammatory and anti-fibrotic effects in the liver. Low levels of
adiponectin are associated with several metabolic conditions including T2D and
NASH, and with an increased risk for cardiovascular disease. PPAR signaling is
involved in disease pathways common to NASH and T2D, and this abstract evaluates
the effect of lanifibranor, a pan-PPAR agonist, on adiponectin levels and
improvement of markers of cardiometabolic health in patients with T2D and NASH.
Inventiva's 'NATIVE' Phase IIb clinical trial, which evaluated lanifibranor in
patients with non-cirrhotic NASH, has demonstrated beneficial effects on liver
histology, NASH resolution and fibrosis regression. The authors of the abstract
show that lanifibranor significantly increases the levels of adiponectin and
that this increase is correlated with the improvements of cardiometabolic
markers, including insulin resistance, glycemic control, lipid metabolism, and
systemic inflammation, in patients with NASH and T2D or prediabetes.
The details of the presentation are as follows:
Date: June 25, 2023
Timing of the poster session: 11:30am-12:30 pm PT
Poster identifier: 844-P
"Lanifibranor Improves Markers of
Abstract title: Cardiometabolic Health in Patients with NASH and
Type 2 Diabetes, Correlated with Responses in
Adiponectin Levels"
Author: Dr. Louis Griffel, Vice President Clinical
Development, Inventiva
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 PPAR? and PPAR?, and a partial
activation of PPAR?. 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 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
(http://www.inventivapharma.com/)
Contacts
Brunswick Group
Tristan Roquet
Montegon / Westwicke, an ICR
Inventiva Company
Aude Lepreux /
Pascaline Clerc Patricia L. Bank
Matthieu Benoist
VP of Global External Investor relations
Affairs Media relations
patti.bank@westwicke.
media@inventivapharma inventiva@brunswickgro com
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Important Notice
This press release contains "forward-looking statements" within the meaning of
the safe harbor provisions of the Private Securities Litigation Reform Act of
1995. All statements, other than statements of historical facts, included in
this press release are forward-looking statements. These statements include, but
are not limited to, forecasts and estimates with respect to Inventiva's pre-
clinical programs and clinical trials, including design, duration, timing,
recruitment costs, screening and enrolment for those trials, including the
ongoing NATiV3 Phase III clinical trial with lanifibranor in NASH and the LEGEND
Phase IIa combination trial with lanifibranor and empagliflozin in patients with
NASH and type 2 diabetes, potential development of and regulatory pathway for
odiparcil, clinical trial data releases and publications, the information,
insights and impacts that may be gathered from clinical trials, the potential
therapeutic benefits, including reduction of IHTG, reduction of steatosis,
improvement of hepatic and peripheral insulin sensitivity and improvement of a
panel of markers of cardiometabolic health, reduction in fasting plasma glucose,
atherogenic dyslipidemia, hepatic insulin action, insulin-stimulated muscle
glucose disposal, reversal of adipose tissue dysfunction with a robust increase
in plasma adiponectin, and reversal of steatohepatitis and fibrosis, of
Inventiva's product candidates, including lanifibranor, the publication by Dr.
Cusi of additional secondary endpoints, including a series of markers of
cardiometabolic health and more detailed analyses, potential regulatory
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has a limited operating history and has never generated any revenue from product
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the absence of which, Inventiva may be required to significantly curtail, delay
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Inventiva's product candidate claims, Inventiva's expectations with respect to
the changes to the clinical development plan for lanifibranor for the treatment
of NASH may not be realized and may not support the approval of a New Drug
Application, 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, the ability of Inventiva to recruit and
retain patients in clinical studies, enrolment 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
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other properties that could delay or prevent their regulatory approval, or limit
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Please refer to the Universal Registration Document for the year ended December
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