* The phase II study led by Dr. Kenneth Cusi evaluating lanifibranor in
patients with T2D and MASLD was selected as late breaker.
* Two additional scientific abstracts from the NATIVE Phase IIb clinical trial
evaluating lanifibranor for the treatment of patients with NASH have been
selected for presentation. The two abstracts show:
* the correlation between the increase of adiponectin under lanifibranor
and the improvement of histological and serum markers of NASH severity
both in terms of activity and fibrosis.
* the improvement of liver histology and markers of cardiometabolic health
in patients with NASH treated with lanifibranor, independent of PNPLA3
genotype.
Daix (France), Long Island City (New York, United States), November 6, 2023 -
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 nonalcoholic steatohepatitis (NASH) and other
diseases with significant unmet medical needs, today announced that the phase II
trial led by Dr. Cusi in patients with type two diabetes (T2D) has been accepted
as late breaker, at the upcoming The Liver Meeting® 2023 hosted by the American
Association for the Study of Liver Diseases on November 10-14, 2023 in Boston.
In addition two other scientific abstracts have been selected for poster
presentation.
The late breaker abstract "Lanifibranor reverses insulin resistance and improves
glucose and lipid metabolism in patients with type 2 diabetes (T2D) and
metabolic dysfunction-associated steatotic liver disease (MASLD)" presents
results from a study sponsored by Dr. Cusi at the University of Florida, that
evaluates the effect of lanifibranor on insulin resistance in the liver, muscle
and adipose tissue, as well as its effect on intrahepatic triglyceride (IHTG)
content in patients with T2D and Metabolic dysfunction associated steatotic
liver disease (MASLD)(1).
The second abstract evaluates the correlation between adiponectin response with
lanifibranor and the improvement of histological and serum markers of NASH
severity, both in terms of disease activity and fibrosis. The change in
adiponectin levels at end of treatment (categorized as unchanged, moderate or
high increase) correlated positively to histological endpoints of NASH
resolution and no worsening of fibrosis, improvement of fibrosis and no
worsening of NASH, and NASH resolution and fibrosis improvement. The degree of
adiponectin level increase correlated also with improvement of the NASH-CRN and
SAF-Activity scores as well as with improvement of the individual components:
steatosis, inflammation and ballooning. Lanifibranor-associated adiponectin
increase also correlated with the improvement in histological fibrosis stage,
pro-C3 levels and MACK-3 score. These data further support that adiponectin is a
biomarker for the efficacy of lanifibranor treatment across the disease spectrum
of NASH, from cardiometabolic health - as previously shown - to hepatic health.
As a reminder, a 3.82 and 4.50 fold increase in adiponectin level were
respectively reported in the 800mg arm and 1200mg arm during Inventiva's NATIVE
Phase IIb clinical trial.
The third abstract evaluates the impact of the PNPLA3 variant I148M, which is
strongly associated with risk for and the progression of NASH, on the
histological and cardiometabolic response to lanifibranor. In a retrospective
analysis of Inventiva's NATIVE Phase IIb clinical trial evaluating lanifibranor
for the treatment of patients with NASH, histological and circulating marker
responses were evaluated by PNPLA3 genotype subgroup. The response to
lanifibranor treatment on the histological endpoints was similar across the
three PNPLA3 genotype (II/IM/MM) despite a higher activity score measured at
baseline in patients with MM genotype.
In addition, the improvement of cardiometabolic health markers (glycemic
control, insulin, HOMA-IR, HsCRP, CAP and adiponectin) following treatment with
lanifibranor was similar in the three PNPLA3 genotypes. These results
demonstrate that the efficacy of lanifibranor on both liver histology and
markers of cardiometabolic health appears to be independent of PNPLA3 status.
The details of the presentation are as follows:
Abstracts:
"Lanifibranor reverses insulin resistance and improves
glucose and lipid metabolism in patients with type 2
diabetes (T2D) and metabolic dysfunction-associated
Abstract title: steatotic liver disease (MASLD)"
Poster number: 5035-C
Presentation type: Late breaker poster presentation
Diana Barb, Srilaxmi Kalavalapalli, Eddison Godinez Leiva,
Fernando Bril, Philippe Huot-Marchand, Lucile Dzen, Jean-
Louis Junien, Pierre Broqua, Andrea Ortiz Rocha, Romina
Authors: Lomonaco, Michael P Cooreman, Ken Cusi
Date: November 12, 2023 - 1:00pm - 2:00pm (EST)
"Lanifibranor-associated adiponectin increase correlates
with improvement of histological and serum markers of NASH
Abstract title: severity both in terms of activity and fibrosis"
Poster number: 2458-C
Presentation type: Poster presentation
Michael P. Cooreman, Manal F. Abdelmalek, Philippe Huot-
Marchand, Lucile Dzen, Martine Baudin, Jean-Louis Junien,
Authors: Pierre Broqua, Sven Francque
Date: November 11, 2023 - 8:30am - 5:00pm (EST)
"Lanifibranor improves liver histology and markers of
cardiometabolic health in patients with NASH independent of
PNPLA3 genotype: a retrospective analysis of the native
Abstract title: study"
Poster number: 2457-C
Presentation type: Poster presentation
Louis Griffel, Sven Francque, Manal F. Abdelmalek, Philippe
Huot-Marchand, Lucile Dzen, Martine Baudin, Jean-Louis
Authors: Junien, Pierre Broqua, Michael P. Cooreman
Date: November 11, 2023 - 8:30am - 5:00pm (EST)
Inventiva will also be present with a booth: we are inviting you to visit us
from Saturday November 11 through Monday November 13, 2023, during exhibition
hall opening hours at booth #D3027 located in the exhibition hall of the
conference center.
About lanifibranor
Lanifibranor, Inventiva's lead product candidate, is an orally-available small
molecule that acts to induce anti-fibrotic, 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 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 (also known as metabolic dysfunction-associated
steatohepatitis (MASH)), 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 an
oncology development 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 Montegon
/ Westwicke, an ICR
Inventiva Company
Aude Lepreux /
Pascaline Clerc Patricia L. Bank
Matthieu Benoist
EVP, Strategy and Investor relations
Corporate Affairs Media relations
patti.bank@westwicke.c
media@inventivapha inventiva@brunswickgroup om
rma.com .com (mailto:patti.bank@wes
(mailto:media@inve (mailto:inventiva@brunsw twicke.com)
ntivapharma.com) ickgroup.com)
+1 240 620 9175 +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, pre-clinical programs and clinical trials, including design,
duration, timing, recruitment costs, screening and enrolment for those trials,
including the ongoing NATiV3 Phase III clinical trial with lanifibranor in NASH
and LEGEND Phase IIa clinial trial, clinical trial data releases and
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clinical trials, the potential therapeutic benefits of Inventiva's product
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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 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, 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 clinical trials may not support Inventiva's product candidate
claims, 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 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, 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 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 the Gaza and Israel
related sanctions and related impacts and potential impacts on the initiation,
enrolment and completion of Inventiva's and its partners' clinical trials on
anticipated timelines, health epidemics, and macroeconomic conditions, including
global inflation, 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, the
Annual Report on Form 20-F for the year ended December 31, 2022 filed with the
Securities and Exchange Commission on March 30, 2023 and the Company's half-year
report for the period ended June 30, 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 statement.
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