- Recruitment in NATiV3 clinical trial continues in both cohorts
with over 80% of the targeted number of patients enrolled in the
main cohort and 100% in the exploratory cohort of NATiV3.
- Analysis of the baseline characteristics of all patients
randomized in the main cohort of NATiV3 show a patient profile
similar to patients randomized in the NATIVE Phase IIb clinical
trial.
- A blinded analysis of all randomized patients suggests weight
gain plateaus and stabilizes between week 24 and 36.
- First visit of the last patient of NATiV3 is anticipated to
occur during the second half of 2024, and topline results are
expected at the beginning of the second half of 2026.
- Patent portfolio strengthened with new patent secured
protecting the compound until 2043.
- The Company is currently working on multiple fronts to secure
financing to fund the continuity of its activities.
Daix (France), Long Island City (New
York, United States), July 5, 2024 – Inventiva
(Euronext Paris and Nasdaq: IVA) (“Inventiva” or
the “Company”), a clinical-stage biopharmaceutical
company focused on the development of oral small molecule therapies
for the treatment of patients with metabolic dysfunction-associated
steatohepatitis (“MASH”), also known as
non-alcoholic steatohepatitis (“NASH”), and other
diseases with significant unmet medical needs, today provided an
update on its clinical program evaluating lanifibranor for the
treatment of MASH/NASH and its financial position.
Frederic Cren, Chairman, Chief Executive
Ofiicer, and cofounder of Inventiva stated: "We have made
good progress with the recruitment in our Phase III clinical trial
and continue to see a strong engagement of clinical trial sites in
NATiV3. We are encouraged by the patient characteristics we are
seeing in the main cohort of NATiV3 compared to those of our Phase
IIb trial and above all by the plateau effect we see in the weight
gain curve which confirms the differentiated profile of our panPPAR
compound versus single PPAR gamma compounds such as pioglitazone.
The data obtained from our various clinical studies demonstrate
that lanifibranor could fully address the broad spectrum of the
disease and recent presented data at the EASL Liver Congress from
other compounds in development further bolster our belief in the
potential of oral lanifibranor for use alone or in combination
therapy. We are continuing to evaluate financing options to extend
our current cash runway and continue our activities as we are
determined to bring lanifibranor to market as a treatment option
for patients with MASH.”
Update on its clinical program
evaluating lanifibranor for the treatment of MASH
The recruitment in NATiV3 is advancing with
screening ongoing at 347 sites across 19 countries. As of July 5,
2024, 1,027 patients have been randomized of which 784 patients in
the main cohort of NATiV3, representing 82% of the targeted number.
The geographical distribution of the main cohort confirms that
North America and Western Europe are the key contributors to
patient recruitment (67% and 21% respectively) while China has only
contributed marginally (2% of patients). The targeted number of 200
patients to be recruited in the exploratory cohort has been met
with 243 patients randomized to date. The recruitment in the
exploratory will continue until recruitment is complete in the main
cohort.
The Company estimates that, given the number of
patients currently in screening who are eligible for enrolment in
the main cohort, the Company must recruit an additional 165
patients. Due to a delay of approximately 3 to 5 months in
recruitment, the Company is currently now targeting: the last
patient first visit for the second half of 2024 and the publication
of the topline results in the beginning of the second half of
2026.
The baseline characteristics of the patients
enrolled so far in the main cohort are in line with the
expectations of the Company and are consistent with those from the
NATIVE Phase IIb clinical trial of lanifibranor in patients with
MASH/NASH (“NATIVE”). In addition, 13% of patients
enrolled in the main cohort were receiving a stable dose of GLP1
receptor agonist and 9% a stable dose of SGLT2 inhibitors at
baseline and should provide the Company with insights on the
potential of the benefits of a combination of these class of
products with lanifibranor.
Importantly, a blinded review which included 780
patients enrolled in the main cohort of NATiV3 (placebo and
treatment arms pooled) showed a similar weight gain as the one
observed during the NATIVE Phase IIb trial which seems to plateau
and stabilize after 24 to 36 weeks of treatment, and this even in
the subgroup of patients who have gained more than 5% weight. If
confirmed, this encouraging result highlights the particular
profile of lanifibranor versus single PPAR gamma in particular
pioglitazone, where such a plateau effect has not been
observed1.
Intellectual property
strategy
We continue to work to reinforce lanifibranor
patent portfolio. As of today, lanifibranor patent portfolio is
made up of 20 patent families comprising both patents and patent
applications fully owned by Inventiva. These patent families are
respectively directed to lanifibranor product, method of treatment,
combination therapy, process, formulation and diagnostic methods.
With our patent family directed to crystalline forms of
lanifibranor (patent applications pending), the company expects to
potentially extend protection on lanifibranor product until at
least 2043.
Financial update
Considering the Company’s cost structure and
forecasted expenditures, and without taking into account additional
cash preservation measures that the Company may implement in the
short term, the Company estimates that its cash, cash equivalents
and deposits will allow the Company to fund its operations as
planned through the second half of July 20242. The Company
estimates that, as of May 31, 2024, the Company’s cash and cash
equivalents were (non-audited) €9.6 million, short-term deposits
were €0.1 million3, and long-term deposits were €10.0 million4,
compared with €26.9 million, €0.01 million and €9 million,
respectively, as of December 31, 2023.
In order to finance its activities and advance
its development objectives for its research and development
programs, the Company will need to raise additional funds. To date,
the Company has explored a variety of transactions, including the
issuance of debt, equity and other instruments, which thus far have
not been successful. However, the Company is working to complete a
royalty-based financing that would extend its cash runway through
the summer of 2024, which it anticipates announcing in the
near-term. Even if the royalty-based financing is successful
(of which there can be no assurance), the Company will need to
raise additional funds, and it is continuing to actively evaluate
potential financing (including debt, equity and equity-linked or
other instruments) and strategic options.
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 MASH/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 MASH/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
MASH/NASH and F2/F3 stage of liver fibrosis. The trial takes place
in 24 countries and in more than 400 clinical sites and recruits
approximately 900 patients to be treated over a 72-week period. The
effect of lanifibranor will be assessed on several histological
endpoints, including MASH/NASH resolution and improvement of
fibrosis of at least one stage. An exploratory cohort is
anticipated to enroll approximately 200 patients with MASH/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 MASH/NASH. Topline results of NATiV3 are expected
for the second 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 MASH/NASH 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 MASH/NASH, a common and
progressive chronic liver disease.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 |
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Important Notice
This press release contains certain
“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, statements with respect
to Inventiva’s estimated cash position, including its estimated
cash runway, Inventiva’s review of potential financing and
strategic options and their outcome and likelihood of success, the
completion of a royalty-based financing that would extend its cash
runway through the summer, the success of Inventiva’s intellectual
property strategy, as well as statements regarding Inventiva’s
clinical trial, including the design, duration, timing,
recruitment, costs, screening and enrollment for those trials,
including the ongoing NATiV3 Phase III clinical trial with
lanifibranor in MASH/NASH, 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 alone and
in combination with other treatments, potential regulatory
submissions and approvals, and Inventiva’s pipeline and preclinical
and clinical development plans, business and regulatory strategy,
the anticipated timing of Inventiva's Phase III clinical trial of
lanifibranor, the commercialization of lanifibranor and achievement
of any sales related thereto, and anticipated future performance.
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”, “opportunity”,
“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 SUSAR on enrollment 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
ability to obtain financing and to enter into potential
transactions, 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 its clinical trials may prove to be wrong and regulatory
authorities may require holds and/or amendments to Inventiva’s
clinical trials, Inventiva’s expectations with respect to the
clinical development plan for lanifibranor for the treatment of
MASH/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, 2023, filed with the Autorité des
Marchés Financiers on April 3, 2024, and the Annual Report on Form
20-F for the year ended December 31, 2023, filed with the
Securities and Exchange Commission (the “SEC”) on April 3,
2024 for other risks and uncertainties affecting Inventiva,
including those described under the caption “Risk Factors”, and in
our future filings with the SEC. 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 Sanyal A et al. NEJM, 362 ; 18, 20102 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 Short-term deposits are classified as "other
current assets" in the consolidated statement of financial position
under IFRS and are considered by the Company to be liquid and
readily available.4 The two-year long-term deposit can be accessed
before expiry of the term with 31 days' notice and is considered
liquid by the Company.
- Inventiva - PR - NATiV3 and fiancial situation updates - EN -
07 05 2024
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