Inventiva receives a €4 million milestone payment from AbbVie for
cedirogant Phase IIb initiation
Daix (France), Long Island City (New York,
United States), January 31, 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 non-alcoholic steatohepatitis (NASH),
mucopolysaccharidoses (MPS) and other diseases with significant
unmet medical needs, today announced the receipt of a €4 million
milestone payment from AbbVie. It follows the inclusion of the
first patient with psoriasis in the ongoing Phase IIb clinical
trial with cedirogant (ABBV-157)1, an oral RORg inverse agonist
jointly discovered by Inventiva and AbbVie for the treatment of
autoimmune diseases.
The Phase IIb clinical trial initiated by AbbVie
with cedirogant is a multicenter, randomized, double-blind,
placebo-controlled, dose-ranging study to evaluate the safety and
efficacy of the drug candidate in adult patients with moderate to
severe plaque psoriasis. The details of the clinical trial are
available on clinicaltrials.gov2.
Frédéric Cren, Chairman, Chief Executive
Officer and cofounder of Inventiva, stated: “This new
milestone payment and the initiation of a Phase IIb trial in adult
patients with psoriasis are excellent news for Inventiva. It is an
important step in the development of cedirogant, after the compound
showed promising activity as an oral psoriasis agent in a Phase Ib
clinical trial led by AbbVie. We are extremely proud to collaborate
with AbbVie, a worldwide leader in autoimmune diseases, and we
believe cedirogant has the potential to become a new reference
treatment in psoriasis and other autoimmune diseases.”
In 2012, Inventiva and AbbVie signed a
multi-year drug discovery collaboration agreement to identify
potent RORg inverse agonists for the treatment of several
auto-immune diseases. Through this collaboration, Inventiva
leveraged its discovery expertise and technology platforms to
develop drug candidates targeting the nuclear receptor RORg, a
validated drug target for the treatment of cutaneous inflammatory
disorders such as psoriasis.
This collaboration with AbbVie enables Inventiva
to receive payments upon the achievement of clinical, regulatory
and commercial milestones, as well as tiered royalties on product
sales, from mid single-digit to low double-digit.
About psoriasis
Psoriasis is a common skin disease affecting
more than 3% of the US adult population3. In moderate and severe
cases, psoriatic lesions can be uncomfortable, itchy and
disfiguring. Although the precise pathophysiology of psoriasis is
unknown, an abnormal cutaneous immunologic/inflammatory response,
associated with epidermal hyper proliferation and abnormal
differentiation, seems to be involved.
Current treatment of psoriasis is directed
toward the alteration of epidermal differentiation, reducing the
inflammatory response and slowing the growth of involved skin
cells. The extent and severity of the disease typically determine
the therapeutic approach. In mild psoriasis, the most commonly used
therapy is topical with the addition of phototherapy in refractory
cases. In moderate to severe psoriasis, phototherapy or anoral
systemic therapy are used.
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 adult 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.
The Company has established a strategic
collaboration with AbbVie in the area of autoimmune diseases
resulting in the discovery of the drug candidate cedirogant
(ABBV-157), an oral RORg inverse agonist. Cedirogant showed
promising activity as an oral psoriasis agent in a Phase Ib
clinical trial and is currently being evaluated in a Phase IIb
clinical trial in patients with moderate to severe chronic plaque
psoriasis. This collaboration enables Inventiva to receive payments
upon the achievement of pre-clinical, clinical, regulatory and
commercial milestones, in addition to royalties on any approved
products resulting from this collaboration.
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.
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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clinical trials, clinical trial data releases, clinical development
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claims, Inventiva may encounter substantial delays in its clinical
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
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
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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 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.
Except as required by law, Inventiva has no
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Inventiva accepts no liability for any consequences arising from
the use of any of the above statements.
1 https://clinicaltrials.gov/ct2/show/NCT050442342
https://clinicaltrials.gov/ct2/show/NCT050442343 Source :
Armstrong et al., JAMA Dermatol. 2021;157(8):940-946.
doi:10.1001/jamadermatol.2021.2007
- Inventiva - PR - Cedirogant milestone - EN - 01.31.2022
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