Inventiva announces positive results of clinical thorough QT study
conducted with lanifibranor
- Trial conducted in 217 patients to evaluate the potential
effect of lanifibranor on the QT/QTc interval in healthy subjects
and to support lanifibranor New Drug Application (NDA) package in
NASH
- Lanifibranor administered at the anticipated maximal
therapeutic dose of 1200mg/day and at the supra-therapeutic dose of
2400mg/day had no impact on QT/QTc interval
Daix (France), Long Island City (New
York, United States), December 6, 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 needs, today announced the
results of a clinical thorough QT/QTc study1 demonstrating the
safety of lanifibranor on cardiac electrical activity.
The assessment of lanifibranor on cardiac
repolarization was conducted in accordance with Food and Drug
Administration guidance2 (FDA) in a phase I double-blind clinical
trial to be included in the NDA package of lanifibranor for the
treatment of NASH. The clinical trial enrolled 217 healthy subjects
who were randomized into four arms, placebo, lanifibranor
1200mg/day (anticipated maximal therapeutic dose), lanifibranor
2400mg/day (supra-therapeutic dose), and moxifloxacin 400mg/day
(positive control). The primary electrocardiogram (ECG) endpoint
was monitored during the first 24hrs and on the last day of
treatment.
Repeated daily administration of lanifibranor
dosed up to 2 fold higher than the anticipated maximal therapeutic
dose had no effect on cardiac electrical activity as shown by
achieving the pre-specified primary endpoint of demonstrating no
prolongation of the QT interval in healthy subjects. Lanifibranor
was well tolerated at both dose levels.
Michael Cooreman, Chief Medical Officer ,
stated: “Thorough QT studies are conducted to measure the
potential risk for a drug to lead to arrhythmia. They are critical
in drug development and are part of the regulatory requirements.
This study confirms the safety of lanifibranor on cardiac activity
previously observed in our Phase II studies.”
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 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 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 preclinical
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 2020, Inventiva announced positive
topline data from its Phase IIb clinical trial evaluating
lanifibranor for the treatment of patients with NASH and obtained
both FDA Breakthrough Therapy and Fast Track designation for
lanifibranor in the treatment of NASH. Lanifibranor is currently
being evaluated in a pivotal Phase III clinical trial.
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 in 2019 and
received both FDA Fast Track and Rare Paediatric Disease
designation for odiparcil in MPS VI.
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
cedirogant (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
InventivaPascaline ClercVP of Global External
Affairs media@inventivapharma.com+1 240 620 9175 |
Brunswick GroupLaurence Frost / 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 |
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trials or Inventiva may fail to demonstrate safety and efficacy to
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and retention of patients in clinical trials is an expensive and
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have other properties that could delay or prevent their regulatory
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studies and clinical development programs and timelines, its
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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 for the year ended December 31, 2020 filed with the
Autorité des Marchés Financiers on March 15, 2021, the Annual
Report on Form 20-F for the year ended December 31, 2020 filed with
the Securities and Exchange Commission on March 15, 2021 as well as
the half-year financial report for the six months ended June 30,
2021 for additional information in relation to such factors, risks
and uncertainties.
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intention and is under no obligation to update or review the
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Inventiva accepts no liability for any consequences arising from
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1 The QT interval is the time between the Q and T waves on an
electrocardiogram. It quantifies the time between the onset of
depolarization of myocardial cells and their repolarization. A
classic side effect of many classes of drugs is the prolongation of
this QT interval.2 Guidance for Industry E14 Clinical Evaluation of
QT/QTc Interval Prolongation and Proarrhythmic Potential for
Non-Antiarrhythmic Drugs (fda.gov)
- Inventiva - PR - TQT study - EN - 6 12 2021
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