Inventiva announces that screening in the NATiV3, Phase III,
clinical trial evaluating lanifibranor in NASH has resumed
- Inventiva has lifted the voluntary pause on screening and
randomization in the NATiV3 clinical trial following the approval
from the US central IRB of the amended protocol and ICF.
- Screening of patients is resuming in sites operating under
central IRB in the US.
- Other sites and countries are expected to resume screening and
randomization activities progressively over the next weeks.
- Last Patient First Visit is currently targeted for first half
2024.
Daix (France),
Long Island City (New York, United States),
March 7, 2024 – 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 non-alcoholic steatohepatitis (NASH) and other
diseases with significant unmet medical needs, today announced that
it has lifted the previously disclosed1 voluntary pause on
screening and randomization of its NATiV3 clinical trial and that
sites are resuming screening activities.
Following the Suspected Unexpected Serious Adverse Reaction
(“SUSAR”) in a patient enrolled in the study, Inventiva chose to
voluntarily pause screening and randomization of new patients in
the NATiV3 trial to implement the recommendations of the
independent Data Monitoring Committee (“DMC”), which included liver
monitoring every 6 weeks for each patient enrolled in the trial,
and amending the protocol to exclude newly screened patients
diagnosed or with a predisposition to autoimmune liver and thyroid
disease. In addition, the Company has made amendments to the
Informed Consent Form (“ICF”) in line with the DMC recommendations.
During the pause, the DMC has continued to receive updates on the
patient status and has reviewed and approved the amendments made to
Inventiva’s study documents.
Inventiva received the first approval from the
central IRB overseeing clinical research in the United
States. Clinical sites located in the United States operating
under central IRB have meanwhile resumed screening and
randomization activities. This is an important milestone as 152
sites of the NATiV3 clinical trial sites are operating under
central IRB and have so far randomized over 60% of the patients in
the main cohort. Inventiva expects to progressively obtain the
approvals required by local authorities to restart screening and
randomization in other countries over the next few weeks.
Frédéric Cren, Chairman, Chief Executive Officer and
cofounder of Inventiva, stated: “The well-being of our
patients is paramount in our clinical research, and we are
delighted to see that the patient who experienced the SUSAR is
expected to make a full recovery. We want to thank all sites and
all patients currently enrolled and in screening for their
dedication to our study. Our team has worked diligently, and we are
pleased to see screening and randomization resuming in our American
sites under central IRB. Our sites operating under central IRB have
contributed to more than 60% of all patients randomized in the
trial and we expect them to be key in securing the last patients
needed to finalize enrollment. Our ongoing interactions with the
NATiV3 sites give us confidence in their strong commitment to
resume the recruitment activities and we are looking forward to
completing enrollment in the NATiV3 study with their
support.”
Prior to the voluntary pause, 913 patients were
already randomized in the NATiV3 clinical trial including 731 in
the main cohort and over 550 patients were in screening. Inventiva
anticipates the last patient first visit for the NATiV3 clinical
trial in the first half of 2024.
About lanifibranor
Lanifibranor, Inventiva’s lead product
candidate, is an orally-available small molecule that acts to
induce antifibrotic, 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 the NATiV3 Phase III
trial
NATiV3 is a randomized, double-blind,
placebo-controlled clinical trial designed to evaluate the
long-term efficacy and safety of lanifibranor (800mg/daily and
1200mg/daily) in adult patients with biopsy-proven non-cirrhotic
NASH and F2/F3 stage of liver fibrosis. The trial takes place in 24
countries and in more than 400 clinical sites and to recruit
approximately 900 patients to be treated over a 72-week period. The
effect of lanifibranor will be assessed on several histological
endpoints, including NASH resolution and improvement of fibrosis of
at least one stage.
An exploratory cohort is anticipated to enrol
approximately 200 patients with NASH and fibrosis screen-failed on
histology for the main NATiV3 clinical trial. Inventiva anticipates
that this exploratory cohort may allow the generation of additional
data using non-invasive tests and contribute to the regulatory
safety database requirement to support the planned submission for
potential accelerated approval to the Food and Drug Administration
(FDA) and potential conditional approval to the European Medicines
Agency (EMA) of lanifibranor for the treatment of NASH.
Topline results of NATiV3 are expected for the
half 2026. For more information about NATiV3, visit
clinicaltrials.gov.
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 a 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
Inventiva Pascaline Clerc, PhDEVP, Strategy and
Corporate Affairs media@inventivapharma.com
+1 202 499 8937 |
Brunswick GroupTristan Roquet Montegon /Aude
Lepreux /Julia CailleteauMedia
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
enrollment for those trials, including the ongoing NATiV3 Phase III
clinical trial with lanifibranor in patients with NASH and the
LEGEND Phase IIa combination trial with lanifibranor and
empagliflozin in patients with NASH, the impact of the SUSAR and
the protocol amendments on clinical trials, including NATiV3 and
LEGEND, and the results and timing thereof and regulatory matters
with respect thereto, expectations with respect to patients in
clinical trials, including the SUSAR patient, the potential for
regulatory authorities to institute clinical holds and/or otherwise
implement additional requirements and/or cause further delays in
clinical trials, including in the NATiV3 and LEGEND trials, the
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, approvals
and commercialization, Inventiva’s pipeline and preclinical and
clinical development plans, and future activities, expectations,
plans, growth and prospects of Inventiva and its partners. 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”, “potential”, “possible”, “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. 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 cannot provide assurance on the impacts of
the pause on enrolment or the ultimate impact on the results or
timing of the NATiV3 trial or regulatory matters with respect
thereto, 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 and its partners’ clinical trials
may not support Inventiva's and its partners’ product candidate
claims, Inventiva's expectations with respect to the impact of the
SUSAR on its clinical trials may prove to be wrong and regulatory
authorities may require additional holds and/or additional
amendments to Inventiva’s clinical trials, 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 and
its partners may encounter substantial delays beyond expectations
in their clinical trials or fail to demonstrate safety and efficacy
to the satisfaction of applicable regulatory authorities, the
ability of Inventiva and its partners to recruit and retain
patients in clinical studies, 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 and its partners’ 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 and its partners' 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 and related sanctions,
impacts and potential impacts on the initiation, enrollment and
completion of Inventiva’s and its partners’ clinical trials on
anticipated timelines and the state of war between Israel and Hamas
and the related risk of a larger conflict, health epidemics, and
macroeconomic conditions, including global inflation, rising
interest rates, 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 as amended on
August 31, 2023, the Annual Report on Form 20-F for the year ended
December 31, 2022 filed with the Securities and Exchange Commission
(the “SEC”) on March 30, 2023, and the Half-Year Report for the six
months ended June 30, 2023 on Form 6-K filed with the SEC on
October 3, 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.
1 Inventiva - PR - Full Year 2023 Revenue et Cash - EN - 02 15
2024- final.pdf (inventivapharma.com)
- Inventiva - PR - NATiV3 screening update - EN - 03 07 2024 -
final
Inventiva (TG:6IV)
과거 데이터 주식 차트
부터 8월(8) 2024 으로 9월(9) 2024
Inventiva (TG:6IV)
과거 데이터 주식 차트
부터 9월(9) 2023 으로 9월(9) 2024