- Chia Tai Tianqing Pharmaceutical Group Co., Ltd., a Sino
Biopharm’s subsidiary, receives IND approval from the NMPA to
initiate the clinical development in mainland China of lanifibranor
in NASH
- Sino Biopharm will participate in the ongoing NATiV3 Phase III
trial which, if positive, is expected to support a potential NDA
filing in China
- In parallel, Sino Biopharm will conduct a Phase I clinical
pharmacology study
- Following this regulatory decision, Inventiva is eligible to
the first of the 2 short term milestones amounting to a total of $5
million, under the license and collaboration agreement with
CTTQ
Daix
(France), Long Island City (New York, United
States), Beijing/Hong Kong (China), May 25, 2023 –
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”) and other diseases with significant unmet
medical needs, and Sino Biopharm, through its subsidiary Chia Tai
Tianqing Pharmaceutical Group Co., Ltd. (“CTTQ”), today announce
that CTTQ received Investigational New Drug (“IND”) approval from
the Chinese National Medical Products Administration (“NMPA”) on
May 22nd 2023, and can now initiate the clinical development of
Inventiva’s lead compound lanifibranor in mainland China.
Frederic Cren,
CEO and cofounder of Inventiva, stated: “We are extremely
pleased by this positive feedback from the NMPA, which allows our
lead compound to advance into a Phase III clinical trial in NASH in
mainland China. This is an important milestone for us and our
partner Sino Biopharm, and brings new opportunities for patients
affected by NASH in China to participate in the global NATiV3 Phase
III clinical trial. We are looking to successfully develop
lanifibranor with Sino Biopharm and potentially commercialize in
China the first oral treatment for patients with NASH.”
Philip
Duong, Head of Overseas BD &
Alliance, Sino Biopharm: “We are
delighted to have received the IND approval from the Chinese NMPA.
This positive step brings us one step closer to potentially
bringing a NASH product candidate to patients with NASH in China, a
growing and devastating disease with no product currently approved.
With its broad mechanism of action acting on the spectrum of NASH
disease, we believe that lanifibranor could potentially be one of
the best-in-class treatments for the estimated 32 million patients
with NASH in China. Our entire team is now looking forward to next
steps and participating in NATiV3.”
Under the proposed clinical program, CTTQ will
enrol patients from China in the global ongoing NATiV3 Phase III
clinical trial, which, if positive, is expected to support a
potential New Drug Application (“NDA”) filing in China, the United
States and Europe. In addition, CTTQ will also conduct in parallel
a Phase I clinical pharmacology study to evaluate the
pharmacokinetics of the 800mg/day and 1200mg/day doses of
lanifibranor in healthy Chinese subjects. CTTQ will be responsible
for all costs linked to lanifibranor development in China.
Following the IND approval, Inventiva is eligible to the first of
the 2 short term milestones amounting to a total of $5 million,
under the license and collaboration agreement with CTTQ.
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,
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 signalling 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
About Sino Biopharm
Sino Biopharm is a leading, innovative
R&D-driven pharmaceutical conglomerate in China. Its business
encompasses a fully-integrated chain which covers an array of
R&D platforms, a line-up of intelligent production and a strong
sales system. Sino Biopharm’s products have gained a competitive
foothold in various therapeutic categories with promising
potential, comprising a variety of biopharmaceutical and chemical
medicines for oncology, surgery/orthopedics, liver disease, and
respiratory system. The collaboration with Inventiva is managed by
invoX Pharma Limited (“invoX”), a wholly owned subsidiary of Sino
Biopharm, headquartered in the United Kingdom. invoX is Sino
Biopharm’s international expansion platform, focusing on R&D
and business development activities outside of China.
For further information about Sino Biopharm,
please visit: http://www.sinobiopharm.com/.
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 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 most advanced 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.
Contacts
Inventiva Pascaline
Clerc VP of Global External Affairs
media@inventivapharma.com +1 240 620 9175 |
Sino Biopharm Philip Duong, Head of
Overseas BD & AlliancePhilip.duong@sino-biopharm.com+86 136
2238 0450 Kyler Lei Head of Capital
Marketskylerlei@sino-biopharm.com+86 138 038 11366 |
|
Brunswick Group Tristan Roquet Montegon,
Aude Lepreux, Matthieu BenoistMedia
relationsinventiva@brunswickgroup.com +33 1 53 96 83 83
|
Westwicke, an ICR Company Patricia L.
BankInvestor relations patti.bank@westwicke.com+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, forecasts and estimates with respect to
Inventiva’s 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, the clinical development
and regulatory plans for lanifibranor of Sino Biopharm and its
affiliates, including the planned Phase III clinical trial in
patients with NASH, the Phase I clinical pharmacology study of
lanifibranor in healthy Chinese subjects, the potential for
lanifibranor to be one of the best-in-class treatments for the
patients with NASH in China, the estimated number of patients with
NASH in China, potential development of and regulatory pathway for
odiparcil, 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, potential regulatory
submissions and approvals, including a potential NDA filing in
China, the United States and Europe, Inventiva’s pipeline and
preclinical and clinical development plans, Inventiva’s
collaboration with CTTQ, future activities, expectations, plans,
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including milestone payments from CTTQ, and the potential of Sino
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results, performance or future events to differ materially from
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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 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 and its partners’ clinical trials
may not support Inventiva's and its partners’ 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 its clinical trials or Inventiva may 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 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 business, and preclinical
studies and clinical development programs and timelines, its
financial condition and results of operations could be materially
and adversely affected by the current geopolitical events, such as
the conflict between Russia and Ukraine, 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, rising interest rates,
uncertain financial markets and disruptions in banking systems.
Given these risks and uncertainties, no representations are made as
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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, and 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 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.
- Inventiva - PR - IND Lanifibranor China - EN - 05 25 2023
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