* 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 disclosed(1) 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 PPAR? and PPAR?, and a partial
activation of PPAR?. 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
(http://www.inventivapharma.com/)
Contacts
Brunswick Group
Tristan Roquet Westwicke, an ICR
Montegon / Company
Aude Lepreux / Patricia L. Bank
Julia Cailleteau Investor
Inventiva Media relations relations
inventiva@brunswick patti.bank@westwi
Pascaline Clerc, PhD group.com cke.com
EVP, Strategy and Corporate (mailto:inventiva@b (mailto:patti.ban
Affairs runswickgroup.com) k@westwicke.com)
media@inventivapharma.com
+1 202 499 8937 +33 1 53 96 83 83 +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.
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