Inventiva announces the screening of the first patient in LEGEND, a
Phase IIa combination trial with lanifibranor and empagliflozin in
patients with NASH and T2D
- The Phase IIa Proof-of-Concept study is designed to assess the
safety and efficacy of lanifibranor in combination with the SGLT2
inhibitor empagliflozin for the treatment of patients with
non-cirrhotic non-alcoholic steatohepatitis (NASH) and type-2
diabetes (T2D)
- The primary efficacy endpoint will be based on improvement in
HbA1c
- Secondary efficacy endpoints include changes in liver enzymes,
markers of glycemic control, lipid metabolism, inflammation and
body fat composition
- Publication of topline results is expected in the second half
of 2023
Daix (France), Long Island City (New
York, United States), July 7, 2022 – Inventiva (Euronext Paris
and Nasdaq: IVA), a clinical-stage biopharmaceutical company
focused on the development of oral small molecule therapies for the
treatment of NASH and other diseases with significant unmet medical
needs, today announced the screening in the United States of
America of the first patient in its LEGEND Phase IIa combination
trial with lanifibranor and empagliflozin in patients with NASH and
T2D 1. Over 30 sites located in France, United Kingdom, Belgium,
Netherlands and United States have already been qualified to
participate in this clinical trial. Topline results are expected to
be published in the second half of 2023.
Prof. Michelle Lai, M.D., Ph.D., Beth Israel
Deaconess Medical Center and co-principal investigator of the
LEGEND Phase IIa clinical trial, said: “The LEGEND trial is
expected to help us better understand the pathophysiology of
patients we care for in our clinics who suffer of NASH and T2D.
Insulin resistance is a root cause leading to the development of
NASH, and the combination of lanifibranor and empagliflozin could
potentially provide complementary effects and provide additional
therapeutic benefits to improve the overall cardiometabolic health
of our patients.”
Dr. Michael Cooreman, Chief Medical Officer
of Inventiva, commented: “We are delighted to see the
initiation of this Proof-of-Concept study, which we believe will
further draw attention to NASH as a multisystemic liver disease
with a highly relevant cardiometabolic aspect. This clinical trial
is anticipated to not only add to the body of evidence
demonstrating the therapeutic benefits of lanifibranor on the broad
spectrum of the disease biology of NASH, but should also
provide insights on how the complementary mechanisms of action of a
pan-PPAR agonist and an SGLT2 inihibitor could enhance the
therapeutic benefits of lanifibranor.”
The Phase IIa trial,
LEGEND, has been designed as a multi-center randomized,
placebo-controlled trial to assess the safety and efficacy of
lanifibranor in combination with the SGLT2 inhibitor empagliflozin
for the treatment of adult patients with non-cirrhotic NASH and
T2D. The trial is double-blind for the placebo and lanifibranor
arms and open-label for the combination of lanifibranor and
empagliflozin arm.
LEGEND is expected to
recruit a total of 63 patients with non-cirrhotic NASH and T2D. In
the trial, the diagnosis of non-cirrhotic NASH will be based on a
historic histology evaluation or a combination of non-invasive
methods including imaging and serum-based metabolic diagnostic
tests.
The primary efficacy
endpoint of the trial is a change in Hemoglobin A1c (HbA1c) at the
end of the 24-week treatment compared to baseline. Secondary
endpoints include changes in liver enzymes, glycaemic and lipids
parameters, inflammatory markers and body fat composition. The
trial is designed to provide valuable information on body weight
evolution and body fat composition in patients with NASH and T2D
when treated with lanifibranor and empagliflozin. Magnetic
resonance imaging (MRI) based imaging will allow the
collection of non-invasive data on hepatic fat, inflammation
and fibrosis.
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. 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 research and development of oral small
molecule therapies for the treatment of 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’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.
The Company has established a strategic
collaboration with AbbVie in the area of autoimmune diseases that
resulted in the discovery of the drug candidate cedirogant
(ABBV-157), an oral RORγ inverse agonist which is being evaluated
in a Phase IIb clinical trial, led by AbbVie, in adult patients
with moderate to severe chronic plaque psoriasis. Inventiva’s
pipeline also includes odiparcil, a drug candidate for the
treatment of adult mucopolysaccharidoses (MPS) VI patients. As part
of Inventiva’s decision to focus clinical efforts on the
development of lanifibranor, it suspended clinical efforts relating
to odiparcil and is reviewing available options with respect to its
potential further development. Inventiva is in the process of
selecting an oncology development candidate for its Hippo signaling
pathway program.
The Company has a scientific team of
approximately 80 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 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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Important Notice
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Private Securities Litigation Reform Act of 1995. All statements,
other than statements of historical facts, included in this press
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recruitment, screening and enrolment for those trials,
including LEGEND, clinical trial data releases and publications,
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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, 2021 filed with the
Autorité des Marchés Financiers on March 11, 2022 and the Annual
Report on Form 20-F for the year ended December 31, 2021 filed with
the Securities and Exchange Commission on March 11, 2022 for
additional information in relation to such factors, risks and
uncertainties.
All information in this press release is as of
the date of the release. Except as required by law, Inventiva has
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forward-looking statements referred to above.
1 For more details, please refer to:
clinicaltrial.gov/NCT05232071.
- Inventiva - PR - LEGEND Screening initiation - EN - 07 07
2022
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