Daix
(France),
Long Island City (New York, United States),
June 3, 2022
– Inventiva (Euronext Paris and Nasdaq: IVA) (the “Company”), a biopharmaceutical company specializing in the development of small molecules administered orally for the treatment of patients with non-alcoholic steatohepatitis (NASH), and other diseases with significant unmet medical needs, today announces selection of abstract
“The Pan-PPAR agonist lanifibranor improves nonalcoholic steatohepatitis (NASH) and glycemic control”
for a poster presentation during the
82
n/a
Scientific Sessions of the American Diabetes Association
which will be held from June 3 to 7, 2022 in New Orleans in the United States.
PPAR signaling is involved in disease pathways common to NASH and type 2 diabetes (T2DM). This abstract highlights the improvement in glycemic control and NASH markers in patients treated with lanifibranor compared to placebo. In Inventiva’s Phase IIb ‘NATIVE’ clinical study, lanifibranor, compared to placebo, demonstrated beneficial effects on liver histology, resolution of NASH and reduction of fibrosis in patients with non-cirrhotic NASH.
Based on data from NATIVE, the authors of the abstract show that glycemic control is correlated with the severity of NASH measured by liver biopsy. In addition, improved glycemic control in patients who received lanifibranor correlates with improved metabolic and immune markers of NASH: insulin resistance, lipid metabolism, inflammation, liver enzymes and fatty liver, as measured by the continuous attenuation parameter (CAP).
The details of the presentation are as follows:
|
Date : | June 5, 2022 |
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Session time: | 1:00-2:00 p.m. (East Coast Time) |
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Poster number: | 830-P |
|
Title of the abstract: |
“The Pan-PPAR agonist lanifibranor improves nonalcoholic steatohepatitis (NASH) and glycemic control” |
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Author : | Dr. Michael P. Cooreman, Inventiva Medical Director |
About Inventiva
Inventiva is a biopharmaceutical company specializing in the research and development of orally administered small molecules for the treatment of patients with NASH and other diseases with significant unmet medical needs. The Company has significant experience and expertise in the development of compounds targeting nuclear receptors, transcription factors and epigenetic modulation. Lanifibranor, Inventiva’s most advanced drug candidate, is currently being evaluated in the pivotal Phase III NATiV3 clinical study for the treatment of adult patients with NASH, a common and progressive chronic liver disease, for which it there is currently no approved treatment.
The Company entered into a strategic partnership with AbbVie in the field of autoimmune diseases which led to the discovery of the drug candidate cedirogant (ABBV-157), an orally administered RORγ inverse agonist whose efficacy in adult patients with moderate to severe plaque psoriasis is being evaluated in a Phase IIb clinical study conducted by AbbVie. Inventiva’s portfolio also includes odiparcil, a drug candidate for the treatment of adult patients with mucopolysaccharidosis (MPS) type VI. As part of its decision to focus its clinical efforts on the development of lanifibranor, Inventiva has suspended its clinical efforts with odiparcil and is reviewing all available options to optimize its development. Inventiva is in the process of selecting a drug candidate in oncology as part of its program dedicated to the Hippo signaling pathway.
The Company has a scientific team of approximately 80 people with strong expertise in biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, as well as in clinical development. Inventiva has a chemical library of around 240,000 molecules, of which around 60% are exclusive to 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”, “continues”, “plans” and other similar expressions. These statements do not relate to proven historical facts, but constitute projections, estimates and other forward-looking data based on management’s opinions, expectations regarding the potential commercial success and potential revenues of Inventiva’s drug candidates. 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 does not have a 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 as well as timelines, its financial condition and results of operations could be materially affected by the COVID-19 pandemic and geopolitical events, such as the conflict between Russia and Ukraine, which could delay the initiation, recruitment and completion of Inventiva’s clinical trials on schedule or delaying them. 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, 2021 filed with the Autorité des marchés financiers on March 11, 2022 and to the Annual Report (“Form 20-F”) for the financial year ended December 31, 2021 filed with the Securities and Exchange Commission on March 11, 2022 for additional information regarding such 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.
Attachment
Inventiva – CP – ADA – FR – 03062022