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 83rd 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 |
Abstract title: |
“Lanifibranor
Improves Markers of 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 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 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
InventivaPascaline 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
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 submissions and approvals, and Inventiva’s
pipeline and preclinical and clinical development plans, future
activities, expectations, plans, growth and prospects. 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”, “would”, “could”, “might”, “should”, “designed”,
“hopefully”, “target”, “aim”, 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, that product candidates will receive the necessary
regulatory approvals, or that any of the anticipated milestones by
Inventiva or its partners will be reached on their expected
timeline, or at all. 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, in the
absence of which, Inventiva may be required to significantly
curtail, delay or discontinue one or more of its research or
development programs or be unable to expand its operations or
otherwise capitalize on its business opportunities and may be
unable to continue as a going concern, 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’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 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 geopolitical events, such as the conflict
between Russia and Ukraine, related sanctions and related impacts
and potential impacts on the initiation, enrolment and completion
of Inventiva’s clinical trials on anticipated timelines, health
epidemics, and macroeconomic conditions, including global
inflation, uncertain financial markets and disruptions in banking
systems. 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, 2022 filed with the Autorité des Marchés
Financiers on March 30, 2023, and the Annual Report on Form 20-F
for the year ended December 31, 2022 filed with the Securities and
Exchange Commission on March 30, 2023 for other risks and
uncertainties affecting Inventiva, including those described from
time to time under the caption “Risk Factors”. Other risks and
uncertainties of which Inventiva is not currently aware may also
affect its forward-looking statements and may cause actual results
and the timing of events to differ materially from those
anticipated.
All information in this press release is as of the date of the
release. 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.
- Inventiva - PR - ADA Abstract- EN - 06242023
Inventiva (EU:IVA)
Historical Stock Chart
From Jun 2024 to Jul 2024
Inventiva (EU:IVA)
Historical Stock Chart
From Jul 2023 to Jul 2024