► The Company will
collaborate with Professor Jérôme Boursier, M.D., Ph.D, a renowned
scientist in the field of non-invasive diagnosis of liver lesions
in chronic liver diseases
► The collaboration aims at
developing one or several biomarkers or a composite biomarker score
to identify patients responding to lanifibranor with regards to
NASH resolution and fibrosis improvement
► The biomarker data from the NATIVE
Phase IIb clinical trial with lanifibranor in NASH will be used as
a first validation dataset and the lanifibranor biomarker signature
would then be validated during upcoming NATIV3 Phase III clinical
trial
Daix (France), February 25,
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 a
collaboration in the field of NASH biomarkers with Professor Jérôme
Boursier, M.D., Ph.D, Professor of Medicine at the Faculty of
Medicine of Angers University and renowned scientist in the area of
non-invasive diagnosis of liver lesions in chronic liver
diseases.
The objective of the collaboration is to
develop one or several biomarkers or a composite biomarker score to
identify patients responding to lanifibranor with regards to NASH
resolution and fibrosis improvement. More specifically, Professor
Jérôme Boursier, M.D., Ph.D, and his team from the HIFIH1
Laboratory (UPRES EA3859, Angers University) will use a
multivariate statistical approach to finding a biomarker signature
of lanifibranor in NASH treatment.
As part of this collaboration, the database from
Inventiva’s NATIVE Phase IIb clinical trial evaluating lanifibranor
for the treatment of NASH and containing a list of around 80
biomarkers will be used as a first validation dataset. The selected
biomarker(s) or biomarker composite score would then be validated
during the upcoming NATIV3 (NASH lanifibranor Phase III trial)
Phase III clinical trial with lanifibranor in NASH, the initiation
of which is planned for the first half of 2021. As a reminder,
several analyses of biomarkers and other non-invasive tests based
on the results from the NATIVE Phase IIb trial had shown promising
treatment effects of lanifibranor versus placebo and were presented
during a webcast event from The Liver Meeting Digital Experience™
2020 on November 16, 2020.2
Pierre Broqua, CSO and cofounder of
Inventiva, commented: “With an increasing
number of patients developing NASH-related end-stage liver disease
and pharmacological treatments on the horizon, there is a pressing
need to develop NASH biomarkers for prognostication, patient
selection and treatment monitoring. We are therefore very excited
to start this collaboration with Professor Jérôme Boursier and his
team, who have been extensively involved in the development of
non-invasive tests to diagnose NASH patients over the past years.
Developing a non-invasive biomarker signature to identify
responders to lanifibranor is totally in line with our strategy to
make our lead drug candidate a reference treatment for NASH
patients.”
Jérôme Boursier, M.D., Ph.D.,
Professor of Medicine at
the Faculty of Medicine of Angers
University, stated: “The need to
develop reliable NASH biomarkers is both clear and urgent as the
utility of liver biopsy, the only diagnostic approach currently
available, is limited due to its invasive nature, poor patient
acceptability and sampling variability. So we are very much
looking forward to working with Inventiva on lanifibranor, a drug
candidate that has shown very promising results in the field of
NASH. Given the efficacy shown by lanifibranor during the NATIVE
Phase IIb trial and the promising biomarker dataset available, we
are confident that we will be able to meet our objective to develop
one or several robust biomarkers or composite biomarker score.”
Biography – Jérôme Boursier
Jérôme Boursier, M.D.,
Ph.D., is Professor of Medicine at the Faculty of Medicine of
Angers University, France. His main field of research covers the
non-invasive diagnosis of liver lesions in chronic liver diseases,
especially Non-Alcoholic Fatty Liver Disease (NAFLD). In parallel,
Professor Boursier heads the HIFIH Laboratory (UPRES EA3859, SFR
4208) at Angers University and the Department of
Hepato-Gastroenterology and Digestive Oncology at Angers University
Hospital. Graduated from the Faculty of Medicine of Angers
University, his Ph.D work focused on methodology to improve the
accuracy of the non-invasive diagnosis of liver fibrosis in chronic
hepatitis C. In the context of a research fellowship at the Anna
Mae Diehl Lab of Duke University, Durham, United States, Professor
Boursier investigated in the area of the gut microbiota and NAFLD.
He currently leads many studies about the diagnosis, screening and
prognosis assessment in NAFLD.
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 earlier
stage 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 July 2020, Inventiva announced positive
topline data from its Phase IIb clinical trial evaluating
lanifibranor for the treatment of patients with NASH and obtained
Breakthrough Therapy and Fast Track designation for lanifibranor in
the treatment of NASH.
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 at the end of
2019 and received FDA Fast Track designation in MPS VI for
odiparcil in October 2020.
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
InventivaFrédéric CrenChairman &
CEOinfo@inventivapharma.com+33 3 80 44 75 00 |
Brunswick GroupYannick Tetzlaff / Tristan Roquet
Montegon / Aude LepreuxMedia
relationsinventiva@brunswickgroup.com+33 1 53 96 83 83 |
Westwicke,
an ICR CompanyPatricia L. Bank Investor
relationspatti.bank@westwicke.com+1 415 513-1284 |
Important Notice
This press release contains forward-looking
statements, forecasts and estimates with respect to Inventiva’s
clinical trials, clinical trial data releases, clinical development
plans and anticipated future activities of Inventiva. Certain of
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“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 pipeline product candidates that the clinical trial results will
be available on their anticipated timeline, that future clinical
trials will be initiated as anticipated, or that candidates 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 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 undesirable side effects 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, 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 filed with the Autorité des Marchés Financiers on June 19,
2020 under n° D.20-0551 and its amendment filed on July 10, 2020
under n° D. 20-0551-A01 as well as the half-year financial report
on June 30, 2020 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 HIFIH: “Hémodynamique, Interaction Fibrose,
Invasivité Tumorales Hépatiques” – Hemodynamics, Fibrosis
Interaction and Hepatic Tumor Invasiveness.
2 A replay of the presentation is accessible via the following
link: https://edge.media-server.com/mmc/p/uy4bgbir.
- Inventiva - PR - Lanifibranor biomarker - 25 02 2021 - EN
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