Inventiva and Echosens launch joint initiative to increase NASH
awareness and access to screening for at-risk patients
Daix (France), Long Island City (New York, United
States) / Paris (France) and Waltham (United States), June
8, 2023 – Inventiva (Euronext Paris and Nasdaq: IVA) (the
“Company”), a clinical-stage biopharmaceutical company focused on
the development of oral small molecule therapies for the treatment
of patients with non-alcoholic steatohepatitis (“NASH”) and other
diseases with significant unmet medical needs and Echosens, a
high-technology company providing a comprehensive range of
diagnostic solutions for liver health, today announce their
collaboration in raising awareness about NASH and increase access
to screening for patients at risk of developing NASH.
NASH is a chronic and progressive metabolic
liver disease that, if left undiagnosed and unmanaged, can lead to
cirrhosis or liver cancer and may result in the need for a liver
transplant. Although NASH is often described as “silent”, patients
with NASH do have an impaired quality of life1 and an increased
risk of cardiovascular and liver-related complications2.
With a global prevalence ranging from 1.5% to
6.45%3 and expected to increase 63% by 20303, there is an urgent
need to diagnose patients at higher risk of progression. This is
why Inventiva and Echosens are joining forces to provide easier
access to screening using FibroScan® in local communities. This
awareness and screening program will take place in about ten
communities at risk for NASH in the United States and Europe, and
will be supported by expert hepatologists and local patient and
community organizations.
Frédéric Cren, Chairman, CEO and cofounder of
Inventiva, stated: “On this 6th annual edition of International
NASH Day, we are extremely proud to join forces with Echosens in
this effort to increase both NASH awareness and identification of
patients at risk of developing NASH. A tremendous effort is still
required to ensure that patients are not left undiagnosed and that
they eventually receive the care that they need. We are delighted
to combine our expertise in the development of potential therapies
for NASH together with Echosens’ world-class know-how in NASH
diagnosis, for this initiative that will shed further light on this
disease and help screen and identify patients at risk of developing
NASH.”
“There is a pressing need for a broader adoption
of non-invasive liver tests to increase the diagnosis rate and
improve the care of people living with NASH. We, alongside with our
partners, have a joint responsibility to shape a future where
patients have access to easy diagnosis solutions and effective
therapies” said Dominique Legros, CEO of Echosens. “We are
very proud to partner with Inventiva to launch initiatives
facilitating screening of NASH and increasing awareness of this
disease among patients, healthcare providers and other
stakeholders.”
About NASH
Non-alcoholic steatohepatitis (NASH) is the most
severe form of non-alcoholic fatty liver disease (NAFLD). It is a
progressive metabolic liver disease characterised by fat
accumulation and inflammation in the liver, which can lead to
scarring, or fibrosis, and eventually end-stage liver disease and
death. The risk of progression to advanced liver disease, including
liver cancer, is higher in people with NASH than in the general
population, and NASH is already the leading cause of waitlist
registration and liver transplant in women in the United States4.
Moreover, NASH increases the risk of developing cardiovascular
diseases5. Known risk factors for NASH include dyslipidaemia, type
2 diabetes, obesity, metabolic syndrome and hypertension. There are
currently no approved treatments for NASH globally, and people with
NASH are left with very few management options.
About Echosens
Pioneer in its field, Echosens significantly
changed the practice of liver assessment with FibroScan®, the
non-invasive solution for comprehensive management of liver health.
For the past decade, FibroScan® has been recognized worldwide and
validated by over 3,500 peer-reviewed publications and 160
international guidelines. Echosens has made FibroScan® available in
over 100+ countries enabling millions of liver examinations
worldwide.
At Echosens we envision a future where…… liver
health is at the core of total health,… every medical professional
has the necessary tools to measure the health of the liver,
identify pathologies, and manage treatments simply, accurately and
effectively,… every patient has the right to receive information
about their liver health in a simple, timely,and easy-to-understand
manner.
www.echosens.com
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 signalling 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
Media InventivaPascaline Clerc,
+1 240 620 9175 – media@inventivapharma.comTristan Roquet
Montegon, +33 1 53 96 83 83 – inventiva@brunswickgroup.com
Investors InventivaPatricia L. Bank, +1
415 513 1284 – patti.bank@westwicke.com
Media EchosensElizabeth Mortek, +1 612
677 2025 – elizabeth@inprela.com
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, the LEGEND Phase IIa
combination trial with lanifibranor and empagliflozin in patients
with NASH and type 2 diabetes and the study with lanifibranor in
patients with NAFLD and T2D, 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
of Inventiva’s product candidates, including lanifibranor,
potential regulatory submissions and approvals, and Inventiva’s
pipeline and preclinical and clinical development plans, future
activities, expectations, plans, growth and prospects of Inventiva,
the potential receipt of the second tranche under the EIB loan and
any potential transaction or receipt of additional funds, future
access to the two-year short-term deposit, and the sufficiency of
Inventiva’s cash resources and estimated cash runway. Certain of
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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
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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. Future 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 the current 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, rising interest rates, uncertain financial markets and
disruptions in banking systems. Given these risks and
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fairness of such forward-looking statements, forecasts and
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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.
1 Kennedy-Martin, T., Bae, J.P., Paczkowski,
R. et al. Health-related quality of life burden of
non-alcoholic steatohepatitis: a robust pragmatic literature
review. J Patient Rep Outcomes 2, 28 (2018).
https://doi.org/10.1186/s41687-018-0052-72 Dulai PS, Singh S, Patel
J, Soni M, Prokop LJ, Younossi Z, Sebastiani G, Ekstedt M, Hagstrom
H, Nasr P, Stal P, Wong VW, Kechagias S, Hultcrantz R, Loomba R.
Increased risk of mortality by fibrosis stage in non-alcoholic
fatty liver disease: Systematic review and meta-analysis.
Hepatology. 2017 May;65(5):1557-1565. doi: 10.1002/hep.29085. Epub
2017 Mar 31. PMID: 28130788; PMCID: PMC5397356.3 Estes C, Razavi H,
Loomba R, et al. Modeling the epidemic of non-alcoholic fatty liver
disease demonstrates an exponential increase in burden of
disease. Hepatology. 2018;67(1):123-133.4 Noureddin M, Vipani
A, Bresee C, Todo T, Kim IK, Alkhouri N, Setiawan VW, Tran T, Ayoub
WS, Lu SC, Klein AS, Sundaram V, Nissen NN. NASH Leading Cause of
Liver Transplant in Women: Updated Analysis of Indications For
Liver Transplant and Ethnic and Gender Variances. Am J
Gastroenterol. 2018 Nov;113(11):1649-1659.5 Angulo P, Kleiner DE,
Dam-Larsen S, et al. Liver fibrosis, but no other histologic
features, associates with long-term outcomes of patients with
nonalcoholic fatty liver disease. Gastroenterology.
2015;149(2):389-397.
- Inventiva - PR - Inventiva and Echosens Joint Effort - EN - 06
08 2023
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