Inventiva provides an update on the development of cedirogant by
AbbVie
Daix (France), Long Island City (New York,
United States), October 31, 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),
mucopolysaccharidoses (MPS) and other diseases with significant
unmet medical needs, today announced that AbbVie communicated
during their third-quarter financial results1 on Friday October
28th, that they decided to stop the development of cedirogant
(ABBV-157), an oral RORg inverse agonist jointly discovered by
Inventiva and AbbVie for the treatment of autoimmune diseases,
following the analysis of a recently concluded nonclinical
toxicology study.
The Company’s cash runway, including the
expected $12 million upfront payment from Sino Biopharm and the €25
million from the EIB credit facility2, is not impacted by the
discontinuation of the cedirogant clinical program and should allow
to fund as previously announced operations through Q4 20233.
Inventiva’s R&D capabilities and objectives remain
unaltered.
Frédéric Cren, Chairman, Chief Executive
Officer and cofounder of Inventiva, stated: “Although we
are disappointed to see the end of cedirogant’s clinical program
following the analysis of a nonclinical toxicology study, we wish
to thank our partner AbbVie for 10 years of collaboration. We are
now fully focused on the development of our lead asset
lanifibranor, a promising treatment which is currently in Phase III
clinical development for the treatment of NASH, a disease for which
there are currently no treatments approved by regulatory agencies.
We continue to make progress in our NATiV3 pivotal Phase III trial
and we recently reached a major milestone in this respect by
entering into a partnership with Sino Biopharm, a leading Chinese
pharmaceutical group, to develop and potentially commercialize
lanifibranor in Greater China.”
In 2012, Inventiva and AbbVie signed a
multi-year drug discovery collaboration agreement to identify
potent RORg inverse agonists for the treatment of several
autoimmune diseases. Inventiva’s and AbbVie’s joint efforts led to
the discovery of cedirogant, which was being evaluated in a Phase
II clinical trial at the time of AbbVie’s decision to discontinue
further clinical development.
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, 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 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 adult 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’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
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 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 |
|
|
|
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
recruitment, screening and enrolment for those trials, including
the NATiV3 Phase III clinical trial with lanifibranor in NASH,
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 lanifibranor, pipeline and
preclinical and clinical development plans, future activities,
expectations, plans, growth and prospects of Inventiva and the
sufficiency of Inventiva’s cash resources and cash runway. 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”, “plans”,
“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. Future 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,
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, 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 COVID-19 pandemic and
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, and macroeconomic
conditions, including global inflation and uncertain financial
markets. 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, 2021 filed with the
Autorité des Marchés Financiers on March 11, 2022, the Annual
Report on Form 20-F for the year ended December 31, 2021 filed with
the Securities and Exchange Commission on March 11, 2022 and the
financial report for the first half of 2022 filed Securities and
Exchange Commission on September 22, 2022 for additional
information in relation to such factors, risks and
uncertainties.
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 Q3 2022 AbbVie Inc. Earnings Conference Call
(media-server.com)2 This estimate is based on the Company’s current
business plan and excludes any potential milestones payable to or
by the Company and any additional expenditures related to the
potential continued development of the odiparcil program or
resulting from the potential in-licensing or acquisition of
additional product candidates or technologies, or any associated
development the Company may pursue. The Company may have based this
estimate on assumptions that are incorrect and the Company may end
up using its resources sooner than anticipated.3
Inventiva-PR-H1-2022-EN-22092022-FINAL-2.pdf
(inventivapharma.com)
- Inventiva - PR - Cedirogant program- EN - 10 31 2022
Inventiva (EU:IVA)
Historical Stock Chart
From Jun 2024 to Jul 2024
Inventiva (EU:IVA)
Historical Stock Chart
From Jul 2023 to Jul 2024