* The Data Monitoring Committee recommended to continue the clinical trial
without modification of the current protocol, based on the pre-planned
review of safety data.
* The recommendation was based on the unblinded review by the DMC of safety
data from more than 900 patients randomized in the main and exploratory
cohorts, including more than 360 and 80 patients that have been treated for
more than 48 and 72 weeks, respectively.
* The patient who experienced the adverse event of increased liver test
results, which was reported as a SUSAR, has been without clinical symptoms
throughout the period of observation and has fully recovered.
* The DMC review confirms the good safety profile of lanifibranor.
Daix (France), Long Island City (New York, United States), May 16, 2024 -
Inventiva (Euronext Paris and Nasdaq: IVA) (the "Company"), a clinical-stage
biopharmaceutical company focused on the development of oral small molecule
therapies for the treatment of metabolic dysfunction-associated steatohepatitis
("MASH"), also known as non-alcoholic steatohepatitis ("NASH"), and other
diseases with significant unmet medical needs, today announced the positive
recommendation from the fourth scheduled meeting of the Data Monitoring
Committee ("DMC") to continue the NATiV3 Phase III clinical trial evaluating
lanifibranor in patients with MASH/NASH without modification to the current
trial protocol.
The DMC, composed of a group of independent experts, conducted its review based
on the unblinded safety data from more than 900 patients randomized in the main
cohort, which includes patients with MASH/NASH and fibrosis stage F2 and F3, and
in the exploratory cohort, which includes patients with MASH/NASH and fibrosis
stage F1 through F4 who are histologically not eligible for the main cohort.
Among the more than 900 patients whose data was reviewed, over 360 patients have
been treated for more than 48 weeks and 80 patients have been treated for more
than 72 weeks. The safety data was unblinded to the DMC but remains blinded with
respect to the Company. The DMC review supports the continuation of the NATiV3
clinical trial without modification to the current trial protocol. This positive
recommendation confirms the good safety and tolerability profile of
lanifibranor.
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 PPAR? and PPAR?, and a partial
activation of PPAR?. 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 FDA has granted Breakthrough Therapy and Fast
Track designation to lanifibranor for the treatment of MASH/NASH.
About the NATiV3 Phase III trial
NATiV3 is a randomized, double-blind, placebo-controlled clinical trial designed
to evaluate the efficacy and safety of lanifibranor (800mg/daily and
1200mg/daily) in adult patients with biopsy-proven non-cirrhotic MASH/NASH and
F2/F3 stage of liver fibrosis. The trial takes place in 24 countries and more
than 400 clinical sites and to recruit approximately 900 patients to be treated
over a 72-week period. The effect of lanifibranor will be assessed on several
histological endpoints, including NASH resolution and improvement of fibrosis of
at least one stage.
An exploratory cohort is anticipated to enrol approximately 200 patients with
MASH/NASH and fibrosis who are not eligible for the main NATiV3 trial.
Inventiva anticipates that this exploratory cohort may allow the generation of
additional data using non-invasive tests and contribute to the regulatory safety
database requirement to support the planned submission for potential accelerated
approval to the Food and Drug Administration (FDA) and potential conditional
approval to the European Medicines Agency (EMA) of lanifibranor for the
treatment of NASH.
For more information about NATiV3, visit clinicaltrials.gov.
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
(http://www.inventivapharma.com/)
Contacts
Brunswick Group
Tristan Roquet Westwicke, an ICR
Inventiva Montegon / Company
Aude Lepreux / Patricia L. Bank
Pascaline Clerc Matthieu Benoist Investor relations
EVP, Strategy and Media relations patti.bank@westwicke.
Corporate Affairs inventiva@brunswickgro com
media@inventivapharma up.com (mailto:patti.bank@we
.com (mailto:inventiva@brun stwicke.com)
(mailto:media@inventi swickgroup.com)
vapharma.com) +1
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and its partners may encounter substantial delays beyond expectations in their
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