Daix (France), Long Island City (New York), United States
January 31, 2022
– Inventiva SA (“Inventiva” or the “Company”) (Euronext Paris and Nasdaq: IVA), a biopharmaceutical company specializing in the clinical development of small molecules administered orally for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidosis (MPS) and other diseases with significant unmet medical need, today announces receipt of a €4 million milestone payment from AbbVie. This follows the inclusion of the first patient with psoriasis in the ongoing Phase IIb clinical study with cedirogant (ABBV-157)
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an orally administrable RORy inverse agonist jointly discovered by Inventiva and AbbVie for the treatment of autoimmune diseases.
The Phase IIb clinical study initiated by AbbVie with cedirogant is a multicenter, randomized, double-blind, placebo-controlled study, including several doses and aimed at evaluating the tolerance and efficacy of the drug candidate in adult patients with psoriasis. in moderate to severe patches. Details of the clinical study are available at clinicaltrials.gov
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Frédéric Cren, Chairman and CEO and co-founder of Inventiva, said:
“This new milestone payment and the launch of the Phase IIb clinical study in patients with psoriasis is great news for Inventiva. This step is very important in the development of cedirogant which has demonstrated, in a Phase Ib clinical study conducted by AbbVie, promising activity as an oral drug candidate for the treatment of psoriasis.
We are extremely proud to collaborate with AbbVie, a world leader in the field of autoimmune diseases, and are convinced that cedirogant has the potential to become a new reference treatment in psoriasis and other autoimmune diseases. »
In 2012, Inventiva and AbbVie entered into a multi-year research partnership to identify RORg inverse agonists for the treatment of several autoimmune diseases. As part of this collaboration, Inventiva is leveraging its expertise in the discovery of new molecules and its technological platforms to develop drug candidates targeting the nuclear receptor RORy, a validated therapeutic target for the treatment of inflammatory skin disorders such as psoriasis. .
This collaboration allows Inventiva to receive payments upon reaching clinical, regulatory and commercial milestones, as well as progressive royalties on product sales in the mid-single digit and low double-digit range.
About Psoriasis
Psoriasis is a common skin disease whose prevalence is estimated between 0.9% and 8% of the world population depending on the country. In moderate and severe cases, psoriatic lesions can be uncomfortable, irritating and disfiguring. Although the exact pathophysiology of psoriasis is not known, an abnormal cutaneous immune/inflammatory response, associated with epidermal hyperproliferation and abnormal differentiation, appears to play a role in the development of the disease.
Current treatment for psoriasis aims at epidermal differentiation, reducing the inflammatory response and slowing the growth of the skin cells concerned. The extent and severity of the disease generally determines the therapeutic approach to be taken. In the mild form of psoriasis, topical treatment is most commonly used, in combination with phototherapy for refractory cases. In moderate to severe cases of psoriasis, phototherapy or systemic oral therapy are used.
About Inventiva
Inventiva is a biopharmaceutical company focused on the clinical development of orally administered small molecules for the treatment of NASH, MPS and other diseases with significant unmet medical need.
Drawing on its expertise and significant experience in the development of compounds targeting nuclear receptors, transcription factors and epigenetic modulation, Inventiva is currently developing two drug candidates, as well as a large portfolio of several programs in the preclinical stage.
Lanifibranor, its lead drug candidate, is currently in development for the treatment of patients with NASH, a common and progressive chronic liver disease for which there are currently no approved treatments. In 2020, Inventiva published positive results from its Phase IIb clinical study evaluating lanifibranor for the treatment of patients with NASH and obtained “Breakthrough Therapy” and “Fast Track” status from the
Food and Drug Administration
(FDA) for lanifibranor in the treatment of NASH. Lanifibranor is currently being evaluated in a pivotal Phase III clinical study.
The company entered into a strategic partnership with AbbVie in the area of autoimmune diseases that led to the discovery of the drug candidate cedirogant (AABV-157), an orally administered RORg inverse agonist. Cedirogant has shown promising activity as an oral drug candidate for the treatment of psoriasis in a Phase Ib clinical study and a Phase IIb clinical study in patients with moderate to severe chronic plaque psoriasis is currently underway. This collaboration allows Inventiva to receive payments upon reaching preclinical, clinical, regulatory and commercial milestones, in addition to royalties on the sales of products developed under this partnership.
Odiparcil is the second clinical-stage drug candidate that Inventiva is developing for the treatment of patients suffering from a subtype of MPS, a group of rare genetic diseases. In 2019, Inventiva published positive results from its Phase IIa clinical study evaluating odiparcil for the treatment of adult patients with MPS VI and obtained “Fast Track” and “rare pediatric disease” status from the US FDA for odiparcil in MPS VI.
In parallel, Inventiva is in the process of selecting a drug candidate in oncology for its program in the Hippo signaling pathway.
The Company has a scientific team of approximately 70 people with strong expertise in biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, as well as in clinical development. In addition, Inventiva has a chemical library of approximately 240,000 molecules, of which approximately 60% are the property of the Company, as well as its own laboratories and equipment.
Inventiva is listed on compartment C of the regulated market of Euronext Paris (Euronext Paris: IVA – ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (symbol: IVA).
www.inventivapharma.com
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Warning
This press release contains forward-looking statements, forecasts and estimates with respect to Inventiva’s clinical studies, clinical development plans, development stage, royalty payments and Inventiva’s future activities. Some of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “projects”, “plans”, “seeks”, “estimates”, “may”, “wants” and “continues” and other similar expressions. These statements do not relate to historically proven facts, but constitute projections, estimates and other forward-looking data based on the opinion of the managers. These statements reflect the opinions and assumptions that were made on the date they were made. They are subject to known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those indicated or implied by such statements. Actual events are difficult to predict and may depend on factors beyond Inventiva’s control. With respect to the pipeline of product candidates, there can be no assurance that the results of clinical studies will be available on schedule, that future clinical studies will be launched as planned, or that these candidates will receive the necessary regulatory approvals. .
Actual results may differ from future results described, implied or anticipated in such forward-looking statements due to a number of important factors, including that Inventiva is a clinical-stage company with no approved products and who has no history of revenue generated from the sale of products. These factors include, in particular, the significant losses generated since the creation of Inventiva, a limited operating history, the absence of income generated by the sale of Inventiva’s products, the need for additional funds to finance its operations.
Inventiva’s future success also depends on the successful clinical development, receipt of regulatory approvals and subsequent commercialization of its current and future product candidates.
Preclinical studies or prior clinical trials are not necessarily predictive of future results, and the results of Inventiva’s clinical trials may not support the reported benefits of Inventiva’s product candidates. Inventiva may experience significant delays in its clinical trials or Inventiva may fail to demonstrate the safety and efficacy of its products to the relevant regulatory authorities. Recruiting and retaining patients in clinical trials is a time-consuming and costly process that could be made more difficult or impossible by multiple factors beyond Inventiva’s control. Inventiva’s product candidates could cause adverse effects or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces significant competition, and the activities, preclinical studies and development programs Inventiva’s clinical development, timelines, financial condition and results of operations could be materially affected by the current COVID-19 pandemic. Given these uncertainties, no representation is made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. In addition, forward-looking statements, forecasts and estimates speak only as of the date of this release. Readers are therefore cautioned not to place undue reliance on these forward-looking statements.
We invite you to refer to the Universal Registration Document for the financial year ended December 31, 2020 filed with the Autorité des marchés financiers on March 15, 2021, the Annual Report (“Form 20-F”) for the financial year ended December 31, 2020 filed with the Securities and Exchange Commission on March 15, 2021 as well as the annual financial report for the year ended December 31, 2020 for additional information regarding these factors, risks and uncertainties.
Subject to applicable regulations, Inventiva makes no commitment to update or revise the information contained in this press release. Inventiva cannot therefore be held responsible for the consequences that may result from the use that would be made of these declarations.
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https://clinicaltrials.gov/ct2/show/NCT05044234
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https://clinicaltrials.gov/ct2/show/NCT05044234
Attachment
Inventiva – PR – Cedirogant milestone – FR – 01.31.2022