25/02/2021 22:00
Inventiva announces collaboration on non-invasive biomarkers to identify patients responding to lanifibranor with regards to NASH resolution and fibrosis improvemen
Télécharger le fichier original

INFORMATION REGLEMENTEE

PRESS RELEASE




Inventiva announces collaboration on non-invasive
biomarkers to identify patients responding to lanifibranor
with regards to NASH resolution and fibrosis improvement

► 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

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.

1
PRESS RELEASE



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.



2
PRESS RELEASE



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

Inventiva Brunswick Group Westwicke, an ICR Company
Frédéric Cren Yannick Tetzlaff / Patricia L. Bank
Chairman & CEO Tristan Roquet Montegon / Investor relations
info@inventivapharma.com Aude Lepreux patti.bank@westwicke.com
+33 3 80 44 75 00 Media relations +1 415 513-1284
inventiva@brunswickgroup.com
+33 1 53 96 83 83
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 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” 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.

3
PRESS RELEASE




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.




4