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Update on Inventiva’s NATiV3 Phase III clinical trial evaluating lanifibranor in patients with NASH and fibrosis (stage F2/F3) non-cirrhotic by Prof. Sven Francque
Update on the current NASH landscape by Dr. Stephen Harrison
Presentation by Dr. Michael Cooreman of three scientific abstracts from NATIVE selected for poster presentations at the EASL International Liver Congress™ 2022
Update on LEGEND, Inventiva’s Phase IIa combination study with lanifibranor and SGLT2 inhibitor empagliflozin in patients with non-cirrhotic NASH and T2D, by Dr. Onno Holleboom
Virtual webcast event to take place on June 28, 2022, at 10:00 am (ET) / 4:00 pm (CET)
Daix (France), Long Island City (New York, United States), June 16, 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, announced today that it will host a webcast event focused on NASH with the participation of three Key Opinion Leaders (KOLs) on June 28, 2022, following the EASL International Liver Congress™ 2022.
Following an introduction from Frédéric Cren, Chairman, CEO and cofounder of Inventiva, and Pierre Broqua, Chief Scientific Officer and cofounder of Inventiva, the event will feature three scientific abstracts presented at the EASL International Liver Congress™ 2022, as well as three presentations focused on the latest news around the development of lanifibranor and various aspects related to NASH. The program will include dedicated Q&A sessions.
The agenda is as follows:
Speakers: Frederic Cren, CEO and cofounder of Inventiva Pharma and Pierre Broqua, Chief Scientific Officer and cofounder of Inventiva Pharma
Update on Inventiva’s NATiV3 Phase III clinical trial in NASH
Speaker: Prof. Sven Francque, Chairman of the Department of Gastroenterology and Hepatology of the University Hospital Antwerp
Update on the NASH field
Speaker: Dr. Steven Harrison, Medical Director for Pinnacle Clinical Research and the President of Summit Clinical Research
Overview of the scientific abstracts presented during the EASL International Liver Congress™ 2022
Speakers: Dr. Michael Cooreman, Chief Medical Officer of Inventiva Pharma
"The pan-PPAR agonist lanifibranor improves markers of cardiometabolic health in patients with NASH independent of weight change."
"Lanifibranor therapy reduces the FibroScan-aspartate aminotransferase (FastTM) score associated with histological 'NASH resolution and improvement of fibrosis' and biomarker response."
"Identification of biomarkers of histological response in patients with non-cirrhotic NASH treated with Lanifibranor."
Update on LEGEND, Phase IIa combination study with lanifibranor and SGLT2 inhibitor empaglifozin in patients with NASH and T2D
Speaker: Dr. Onno Holleboom, Internist, faculty member & Principal Investigator, Amsterdam University Medical Center
The details to connect to the webcast are as follows:
Tuesday, June 28, 2022
10:00 am - 12:00 pm (ET) / 4:00 pm - 6:00 pm (CET)
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/.
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.
Westwicke, an ICR Company
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.