Inventiva announces FDA decision that Fast Track designation
granted to lanifibranor in NASH encompasses the treatment of NASH
with compensated cirrhosis
- The FDA decision follows the Company’s Fast Track designation
request for lanifibranor in NASH with compensated cirrhosis filed
in August 2021
Daix (France), Long Island City (New
York, United States), September 21, 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 need, today announced that
the U.S. Food and Drug Administration (FDA) has decided that the
Fast Track designation previously granted to lanifibranor in NASH
encompasses the treatment of NASH patients with compensated
cirrhosis.
This decision follows a Fast Track designation
request for lanifibranor in NASH with compensated cirrhosis filed
by Inventiva with the FDA in August 2021. Previously, the FDA had
granted both Fast Track and Breakthrough Therapy designations to
lanifibranor for the treatment of NASH in September 2019 and
October 2020, respectively.
The FDA’s dedicated Fast Track program is
designed to facilitate the development and expedite the review and
potential approval of drug candidates demonstrating the capacity to
treat serious conditions and fill significant unmet medical
needs.
Pierre Broqua, Ph.D., Chief Scientific
Officer and cofounder of Inventiva, commented: “We are
delighted to have a Fast Track designation for lanifibranor in NASH
that extends to the treatment of NASH with compensated cirrhosis, a
very severe stage of the disease where patients are in urgent need
of treatment. The FDA decision does not only recognize this urgency
but also the potential of lanifibranor to address this crucial
unmet medical need. This news reinforces our confidence in the
unique mechanism of action of our lead drug candidate and confirms
our determination to accelerate the development of lanifibranor in
its pivotal phase.”
NASH with compensated cirrhosis represents a
serious stage of the disease and is becoming the leading cause for
liver transplantation, which today represents the only available
treatment option for patients who have progressed to end-stage
NASH. There is thus an urgent need to develop pharmacological
therapies to slow down or halt the progression towards NASH with
compensated cirrhosis for NASH patients who are at an increased
risk of liver-related morbidity and mortality.
Given the broad range of activity of
lanifibranor as a pan-PPAR agonist on multiple features of NASH,
including beneficial effects on metabolism, inflammation,
ballooning, fibrosis and vascular manifestations, Inventiva
believes that there is a strong rationale to evaluate the efficacy
of lanifibranor in NASH patients with compensated cirrhosis.
About Fast Track
designation1
Fast track is a process designed to facilitate
the development and expedite the review and potential approval of
drug candidates to treat serious, life-threatening conditions and
fill an unmet medical need. The purpose is to get important new
drugs to the patient earlier.
Determining whether a condition is serious is a
matter of judgment, but generally is based on whether the drug will
have an impact on factors such as survival, day-to-day functioning,
or the likelihood that the condition, if left untreated, will
progress from a less severe condition to a more serious one.
Filling an unmet medical need is defined as
providing a therapy where none exists or providing a therapy which
may be potentially better than available therapy. Any drug being
developed to treat or prevent a condition with no current therapy
is obviously directed at an unmet need. If there are available
therapies, a Fast Track drug must show some advantage over
available therapy, which is assessed against a pre-defined set of
criteria.
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
Affairsmedia@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. BankInvestor
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 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 the potential benefits Inventiva
may realize from Fast Track designation granted to lanifibranor,
its ability to accelerate the development of lanifibranor, or that
lanifibranor 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, Amendment
No. 1 to the Annual Report on Form 20-F for the year ended December
31, 2020 filed with the Securities and Exchange Commission on March
24, 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
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
(12/09/2019).
- Inventiva - PR - Fast Track - EN - 21092021
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