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Inventiva announces three scientific presentations at the EASL International Liver Congress™ 2022

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  • Three poster presentations showing
    • the beneficial effects of lanifibranor on markers of cardiometabolic health in patients with non-cirrhotic NASH fibrosis independent of weight gain observed.
    • the reduction of the FastTM score in association with the beneficial effects of lanifibranor on liver histology and biologically relevant biomarkers, in patients with NASH and F2/F3 fibrosis.
    • the identification of biomarkers of histological response in patients with non-cirrhotic NASH treated with lanifibranor.

Daix (France), Long Island City (New York, United States), June 9, 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) and other diseases with significant unmet medical needs, today announced that three abstracts have been selected for poster presentation at the upcoming International Liver Congress™ 2022 hosted by the European Association for the Study of the Liver (EASL) on June 22-26, 2022 in London, UK.

The first abstract focuses on the beneficial effects of lanifibranor on markers of cardiometabolic health in patients with NASH showing that they are independent of weight change. Based on the results of Inventiva’s NATIVE Phase IIb clinical trial evaluating lanifibranor in NASH, the authors of the abstract analysed markers of cardiometabolic health in relation with the weight variation observed in patients treated with lanifibranor or on placebo.  The treatment with lanifibranor showed beneficial effects on biomarkers of cardiometabolic health, including markers of lipid and glucose metabolism, insulin resistance and inflammation independent of weight change. These beneficial effects occurred in parallel with an increase of adiponectin levels demonstrating an improvement in adipose tissue health. These results provide further evidence that PPARγ-induced weight gain is associated with improved insulin sensitivity, i.e. is metabolically healthy and thus distinct from lifestyle-related weight gain.

The second abstract evaluates the beneficial effect of lanifibranor treatment on the FibroScan-aspartate aminotransferase (FastTM) score, a promising non-invasive test (NIT) for active NASH with significant fibrosis. Based on the data of the  NATIVE trial, the authors evaluated the effect of treatment with lanifibranor on the FastTM score,the correlation between the histological and biomarker responses observed in patients with NASH and fibrosis F2/F3. The data showed that the treatment with lanifibranor induced a significant reduction of the FastTM score compared to placebo. This reduction under lanifibranor is associated with the histological endpoint ‘resolution of NASH and improvement of fibrosis’, and with the improvement in triglycerides, Apo-C3 and ferritin levels. These results highlight the potential of the FastTM score as a NIT to monitor disease progression and response to therapy. 

The third abstract focuses on the identification of biomarkers of histological response in patients with non-cirrhotic NASH treated with lanifibranor.  The authors conducted an assessment of serum-based biomarkers from the Inventiva’s NATIVE Phase IIb clinical trial in order to identify biological signatures of the liver histological endpoints. The authors identified four biomarkers: baseline levels of adiponectin and ferritin, relative changes of MMP9 and transferrin at end of treatment, which combined into a score could predict the ‘NASH resolution and fibrosis improvement’ with a sensitivity of 70% and specificity of 95%. Four different biomarkers were identified as being predictive of the histological endpoint ‘NASH resolution without worsening of fibrosis’: baseline CK18-M65, absolute change of hyaluronate, relative changes of fructosamine and ALT at end of treatment, with a sensitivity of 79% and specificity of 89%. This exploratory assessment demonstrates that the combination of biomarker signatures allowed a non-invasive identification of histological response under lanifibranor treatment in NASH with a good diagnostic performance.

The details of the various presentations are as follows:

Abstract #1:

Abstract title: "The pan-PPAR agonist lanifibranor improves markers of cardiometabolic health in patients with NASH independent of weight change"
Publication number: SAT119
Presentation type: Poster presentation
Authors: Michael P. Cooreman, Sven Francque, Martine Baudin, Philippe Huot-Marchand, Lucile Dzen, Jean-Louis Junien, Pierre Broqua, Manal F. Abdelmalek
Date: June 25, 2022 - 9:00am- 6:00pm (BST)

Abstract #2:

Abstract title: "Lanifibranor therapy reduces the FibroScan-aspartate aminotransferase (FastTM) score associated with histological 'NASH resolution and improvement of fibrosis' and biomarker response"
Publication number: SAT120
Presentation type: Poster presentation
Authors: Michael P. Cooreman, Manal F. Abdelmalek, Martine Baudin, Philippe Huot-Marchand, Lucile Dzen, Céline Fournier, Jean-Louis Junien, Pierre Broqua, Sven Francque
Date: June 25, 2022 - 9:00am- 6:00pm (BST)

Abstract #3:

Abstract title: "Identification of biomarkers of histological response in patients with non-cirrhotic NASH treated with Lanifibranor"
Publication number: SAT105
Presentation type: Poster presentation
Authors:

Jérôme Boursier, Hugo Hervé, Clémence Canivet, Marine Roux, Pierre Broqua, Michael P. Cooreman, Jean-Louis Junien, Jean-Louis Abitbol, Philippe Huot-Marchand, Lucile Dzen, Sanjaykumar Patel
Date: June 25, 2022 - 9:00am- 6:00pm (BST)

In addition, during the session « Critical reflection on landmark papers », taking place Saturday, June 25th (10:00 to 11:30 – Capital Suite 12), Dr. Manal Abdelmalek will present the results of the Phase IIb clinical trial with lanifibranor: “A randomized, controlled trial of the pan-PPAR agonist lanifibranor in NASH.”

Inventiva will also be present with a booth and we are inviting you to visit us from Thursday, 23rd through Saturday 25th, from 9:00 to 17:00 at booth #19 located in the exhibition hall of the conference center.

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

Inventiva
Pascaline Clerc
VP of Global External Affairs

media@inventivapharma.com
+1 240 620 9175
Brunswick Group
Laurence Frost /
Tristan Roquet Montegon /
Aude Lepreux
Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83
Westwicke, an ICR Company
Patricia L. Bank

Investor relations
patti.bank@westwicke.com
+1 415 513 1284

Important Notice

This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but are not limited to, forecasts and estimates with respect to Inventiva’s pre-clinical programs and clinical trials, including recruitment for those trial, clinical trial data releases, including for part 1 of the Phase III clinical trial of lanifibranor in patients with NASH and two Phase II trials in patients with NAFLD and type 2 diabetes, and in combination with empagliflozine, pipeline and preclinical and clinical development plans, milestone payments, royalties and product sales, future activities, expectations, plans, growth and prospects of Inventiva and the sufficiency of Inventiva’s cash resources and cash runway. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “would”, “could”, “might”, “should”, “plans”, and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management's beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Future events are difficult to predict and may depend upon factors that are beyond Inventiva's control. There can be no guarantees with respect to pipeline product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, that product candidates will receive the necessary regulatory approvals, or that any of the anticipated milestones by Inventiva or its partners will be reached on their expected timeline, or at all. Actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates, due to a number of factors, including that Inventiva is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception, Inventiva has a limited operating history and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, Inventiva's future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of current and any future product candidates, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva's clinical trials may not support Inventiva's product candidate claims, Inventiva may encounter substantial delays in its clinical trials or Inventiva may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, enrolment 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 have other properties that could delay or prevent their regulatory 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 and geopolitical events, such as the conflict between Russia and Ukraine and related impacts and potential impacts on the initiation, enrolment and completion of Inventiva’s clinical trials on anticipated timelines. 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, 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 no intention and is under no obligation to update or review the forward-looking statements referred to above.

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