* The DMC recommended to continue the clinical trial without modification of
the protocol, based on the pre-planned review of safety data
* The safety assessment was based on the review of safety data from more than
500 patients, including patients that have been treated with lanifibranor
for more than 72 weeks
* The DMC review remains consistent, confirming the good safety profile of
lanifibranor
Daix (France), Long Island City (New York, United States), December 4, 2023 -
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 non-alcoholic steatohepatitis (NASH) and other
diseases with significant unmet medical needs, today announced the positive
recommendation from the third meeting of the Data Monitoring Committee (DMC) to
continue the NATiV3 Phase III clinical trial evaluating lanifibranor in patients
with NASH without modification to the trial protocol. The DMC, composed of a
group of independent experts, arrived at this recommendation after review of the
safety data of patients enrolled in the NATiV3 trial.
The DMC review supports the continuation of the NATiV3 clinical trial, in the
absence of a safety signal that would require any modification to the trial
protocol. This safety assessment was based on the review of safety data from
more than 500 patients, including patients that have been treated with
lanifibranor for more than 72 weeks. This positive recommendation confirms the
good safety and tolerability profile of lanifibranor.
Dr Michael Cooreman, Chief Medical Officer, commented: "We are pleased to see
the continued good safety profile of lanifibranor in patients with NASH at this
stage of our study as more patients are enrolled in the NATiV3 clinical trial
and have been receiving treatment with lanifibranor for longer periods of time.
As an orally-available small molecule and the only pan-PPAR agonist currently in
clinical development for the treatment of NASH, lanifibranor has a unique
mechanism of action, targeting the broad disease biology of NASH with fibrosis.
We are very excited about the potential therapeutic benefits that it could
bring to patients, if approved."
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 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 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 the NATiV3 Phase III trial
NATiV3 is a randomized, double-blind, placebo-controlled clinical trial designed
to evaluate the long-term efficacy and safety of lanifibranor (800mg/daily and
1200mg/daily) in adult patients with biopsy-proven non-cirrhotic NASH and F2/F3
stage of liver fibrosis. The trial is designed to take place in approximately
24 countries and more than 350 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 included in parallel to the NATiV3 trial and is
anticipated to include approximately 200 patients with 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 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
(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
+1 240 620 9175 +33 1 53 96 83 83 415 513-1284
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Please refer to the Universal Registration Document for the year ended December
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