Inventiva secures a new patent in Japan, expanding the IP
protection of its lead product candidate lanifibranor
- Japanese Patent Office approved Inventiva’s patent application
relating to the use of lanifibranor for the treatment of
cirrhosis.1
- This patent strengthens Inventiva’s intellectual property with
respect to lanifibranor in Japan for the indication cirrhosis,
including cirrhosis due to MASH/NASH.
Daix (France), Long Island City (New
York, United States), July 25, 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 announced that
the Japan Patent Office (“JPO”) has approved Inventiva’s patent
application No. JP 2019-203498, protecting the use of lanifibranor
for the treatment of patients with cirrhosis. This new patent will
be valid until November 8, 2039, excluding any potential patent
term adjustments or extensions that may provide additional
protection.
The patent granted by the JPO expands the
intellectual property protection of lanifibranor for use in
patients with cirrhosis including patients with cirrhosis due to
MASH/NASH, complementing the protection previously granted by the
United States Patent and Trademark Office2. The approval
of this patent further strengthens Inventiva’s patent portfolio for
lanifibranor, the Company’s lead product candidate. To date, this
portfolio is composed of 20 patent families directly owned by
Inventiva, including 157 issued patents and more than 50 pending
patent applications. The Company’s patent portfolio, with respect
to lanifibranor, includes patents and patent applications directed
to the product lanifibranor, the methods of treatment, the
combination therapy, the processes, the formulations and diagnostic
methods.
Pierre Broqua, Ph.D., Chief Scientific
Officer and cofounder of Inventiva, stated: “We are
delighted by the Japan Patent Office's decision to grant this
patent for lanifibranor. We believe this patent not only reinforces
our intellectual property position but also highlights
lanifibranor’s potential in addressing significant unmet medical
needs in patients with cirrhosis, in particular cirrhosis due to
MASH/NASH. This new patent complements our existing patent
protection in the United States, and other regions, and strengthens
lanifibranor’s position as a leading candidate for the potential
treatment of MASH/NASH, cirrhosis and other fibrotic
diseases.”
With up to 2.7%3 of Japan's
population with MASH/NASH and no treatment approved by the Japanese
Pharmaceuticals and Medical Devices Agency (PMDA), Inventiva
believes Japan could become an important market for lanifibranor,
if approved. As previously disclosed, Inventiva entered into an
exclusive licensing agreement with Hepalys Pharma, Inc. in
September 2023 to develop and commercialize lanifibranor for the
potential treatment of MASH/NASH in Japan and South Korea.
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 U.S. Food and Drug
Administration has granted Breakthrough Therapy and Fast Track
designation to lanifibranor for the treatment of MASH/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 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, PhD
EVP, Strategy and Corporate Affairs
media@inventivapharma.com
+1 202 499 8937 |
Brunswick Group
Tristan Roquet Montegon /
Aude Lepreux /
Julia Cailleteau
Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83 |
Westwicke, an ICR Company
Patricia L. Bank
Investor relations
patti.bank@westwicke.com
+1 415 513-1284 |
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Important Notice
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“forward-looking statements” within the meaning of the safe harbor
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All statements, other than statements of historical facts, included
in this press release are forward-looking statements.
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including with respect to regulatory approvals, expectations with
respect to the benefits of the agreement with Hepalys Pharma, Inc.,
potential regulatory submissions, approvals and commercialization,
Inventiva’s pipeline and preclinical and clinical development
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Designation and Fast Track designation to lanifibranor for the
treatment of MASH/NASH, including its impact on the development and
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Inventiva cannot provide assurance on the impacts of the
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candidates, preclinical studies or earlier clinical trials are not
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Please refer to the Universal Registration
Document for the year ended December 31, 2023, filed with the
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for other risks and uncertainties affecting Inventiva, including
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1 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.
2
inventivapharma.com/wp-content/uploads/2022/11/Inventiva-PR-Lanifibranor-New-patent-US-EN-11-28-2022.pdf
3 Eguchi Y, Wong G, Lee EI, Akhtar O, Lopes R, Sumida Y.
Epidemiology of non-alcoholic fatty liver disease and non-alcoholic
steatohepatitis in Japan: A focused literature review. JGH Open.
2020 May 5;4(5):808-817.
- Inventiva - PR - Lanifibranor Cirrhosis patent Japan - 07 25
2024
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