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Inventiva announces three scientific presentations at the EASL International Liver Congress™ 2021 and during a KOL webcast event
Two oral presentations showing
the beneficial effects of lanifibranor on cardiovascular risk biomarkers in patients with NASH
the positive effects of lanifibranor on several biomarkers of disease activity and associated risks in patients with NASH and F2/F3 fibrosis
One poster presentation showing the beneficial effects of the combination treatment of lanifibranor and ACC1/2 inhibitor firsocostat from Gilead
Inventiva will host a dedicated Key Opinion Leader (KOL) webcast event for investors and analysts on June 29, 2021
Daix (France), June 9, 2021 – 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 need, today announced that three abstracts have been selected for presentation at the upcoming International Liver Congress™ 2021 hosted by the European Association for the Study of the Liver (EASL), June 23-26, 2021. Inventiva will also host a KOL webcast event on June 29, 2021, focusing on the three abstracts, the current NASH field and Inventiva’s upcoming Phase III clinical trial on lanifibranor (further details below).
The first abstract focusing on the beneficial effects of lanifibranor on cardiovascular risk biomarkers has been selected for an oral presentation. Based on the results of Inventiva’s NATIVE Phase IIb clinical trial evaluating lanifibranor in NASH, the authors of the abstract analyzed the change in the cardiovascular risk profile in patients with NASH by measuring several serum biomarkers. Lanifibranor showed beneficial effects on several cardiovascular risk biomarkers, including dyslipidemia, insulin resistance, inflammation and high blood pressure, confirming its promising profile as a potential treatment for NASH.
The second abstract covering the positive effects of lanifibranor on biomarkers of disease activity and associated risks in patients with NASH and F2/F3 fibrosis has also been selected for an oral presentation. Based on the results of the Company’s NATIVE Phase IIb clinical trial, the authors of the abstract evaluated the effects of lanifibranor on several serum biomarkers of lipid metabolism, insulin resistance, liver injury, inflammation and fibrosis in the patient subgroup with F2/F3 fibrosis. The data showed that lanifibranor improved all selected serum biomarkers, confirming its previously reported histological efficacy, and supporting Inventiva’s focus on patients with NASH and F2/F3 fibrosis in its upcoming Phase III clinical trial with lanifibranor.
The third abstract covering the beneficial effects of the combination treatment of lanifibranor and the ACC1/2 inhibitor firsocostat from Gilead in a non-clinical model of NASH and fibrosis has been accepted for a poster presentation. The results obtained in this diet-induced murine model showed the beneficial and complementary effects of the two compounds on metabolic lipids, demonstrating greater efficacy than the monotherapy for all parameters evaluated, and leading to further improvement of NASH and fibrosis. This data supports the clinical investigation of a combination of lanifibranor and firsocostat in NASH patients.
The details of the various presentations are as follows:
Abstract #1:
Abstract title: | "Lanifibranor therapy improves markers of lipid metabolism, insulin resistance, liver injury and fibrosis in patients with NASH and F2 and F3 fibrosis stages: a subgroup analysis of the Phase IIb NATIVE study" |
Publication number: | 1044 |
Presentation type: | Oral presentation, abstract session |
Authors: | Sven Francque, Michael P. Cooreman, Martine Baudin, Philippe Huot-Marchand, Lucile Dzen, Jean-Louis Junien, Pierre Broqua, Manal F. Abdelmalek |
Presenting author: | Prof. Sven Francque, University Hospital Antwerp, Co-Principal Investigator of the NATIVE Phase IIb clinical trial |
Date: | June 25, 2021 |
Session time: | 2:15 pm - 2:30 pm CET |
Abstract #2:
Abstract title: | "The pan-PPAR agonist lanifibranor significantly improves cardiovascular risk biomarkers in patients with NASH " |
Publication number: | 1034 |
Presentation type: | Oral presentation, abstract session |
Authors: | Sven Francque, Michael P. Cooreman, Martine Baudin, Philippe Huot-Marchand, Lucile Dzen, Jean-Louis Junien, Pierre Broqua, Manal F. Abdelmalek |
Presenting author: | Prof. Sven Francque, University Hospital Antwerp, Co-Principal Investigator of the NATIVE Phase IIb clinical trial |
Date: | June 25, 2021 |
Session time: | 3:00 pm - 3:15 pm CET |
Abstract #3:
Abstract title: | "Combination therapy of lanifibranor and firsocostat further improves steatohepatitis and fibrosis compared to monotherapy in a Diet-Induced Murine Model of NASH" |
Publication number: | 1727 |
Presentation type: | Poster presentation |
Authors: | Guillaume Wettstein, François Briand, Thierry Sulpice, Jean-Louis Junien and Pierre Broqua |
Date: | June 23, 2021 |
KOL webcast event
To close Inventiva’s participation to the EASL International Liver CongressTM 2021, the Company will host a dedicated KOL webcast event for investors and analysts at 10:00 am (ET) / 4:00 pm (CET) on June 29, 2021, covering the three abstracts mentioned above, the current NASH field, and Inventiva’s upcoming Phase III clinical trial on lanifibranor.
Introduced by Frédéric Cren, Chairman, CEO and cofounder of Inventiva, this event will be composed of three distinct parts, including dedicated Q&A sessions:
Part #1 :
Topic: | "Review of EASL 2021 abstracts" |
Speaker: | Prof. Sven Francque, University Hospital Antwerp, Co-Principal Investigator of the NATIVE Phase IIb clinical trial |
Part #2 :
Topic: | "Update on the NASH field" |
Speaker: | Prof. Arun Sanyal, Virginia Commonwealth University, Member of Inventiva’s Scientific Advisory Board |
Part #3 :
Topic: | "Overview of Phase III NASH trial" |
Speaker: | Dr. Michael Cooreman, Chief Medical Officer of Inventiva |
The details to connect to the webcast are the following:
Date: | Tuesday, June 29, 2021 |
Time: | 10:00 am - 11:30 am (ET) / 4:00 pm - 5:30 pm (CET) |
Connection details: | Option #1 – Webcast: https://edge.media-server.com/mmc/p/d7qtzuzi |
The presentation document and the link to the webcast (live and replay) will also be available on Inventiva’s website in the “Investors – Investor Presentations” section: http://inventivapharma.com/investors/investor-presentations/.
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 earlier stage 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 patients with NASH and obtained Breakthrough Therapy and Fast Track designation for lanifibranor in the treatment of NASH.
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 at the end of 2019 and received FDA Fast Track designation in MPS VI for odiparcil in October 2020.
In parallel, Inventiva is in the process of selecting an oncology development candidate for its Hippo signalling pathway program. Furthermore, the Company has established a strategic collaboration with AbbVie in the area of autoimmune diseases. AbbVie has started the clinical development of ABBV‑157, a drug candidate for the treatment of moderate to severe psoriasis resulting from its collaboration with Inventiva. This collaboration enables Inventiva to receive milestone payments upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on any approved products resulting from the collaboration.
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
Inventiva | Brunswick Group | Westwicke, an ICR Company |
Important Notice
This press release contains forward-looking statements, forecasts and estimates with respect to Inventiva’s clinical trials, clinical trial data releases, clinical development plans and anticipated future activities of Inventiva. 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” 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. Actual 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, or that candidates will receive the necessary regulatory approvals. 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 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, enrollment 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. 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 full-year financial report for the year ended December 31, 2020 for additional information in relation to such factors, risks and uncertainties.
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. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.
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