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2020-10-28

Inventiva to host a Key Opinion Leader webcast from the AASLD The Liver Meeting Digital Experience™ 2020

 

     ►     Presentation of the results from the NATIVE Phase IIb clinical trial evaluating lanifibranor in NASH by Prof. Sven Francque
      
     ►     Presentation of the current NASH landscape by Prof. Arun Sanyal
             
     ►     Discussion on management of NASH patients by Prof. Kenneth Cusi

     ►     Virtual webcast event on November 16, 2020 at 4:00 pm (ET) / 10:00 pm (CET)


Daix (France), October 28, 2020
– 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 it will host a webcast event focused on NASH with the participation of three Key Opinion Leaders (KOL) on November 16, 2020 from The Liver Meeting Digital Experience™ 2020, organized by the American Association for the Study of Liver Diseases (AASLD).

Introduced by Frédéric Cren, Chairman, CEO and cofounder of Inventiva, this event will be composed of three distinct KOL presentations focused on various aspects related to NASH, including dedicated Q&A sessions.

The presentation details are as follows:

Presentation #1 :

  • Title:  “Discussion of the Phase IIb NATIVE clinical trial results evaluating lanifibranor in NASH”
  • Speaker: Prof. Sven Francque, University Hospital Antwerp, Co-Principal Investigator of the NATIVE Phase IIb clinical trial  
  • Topics covered: Topline results from the NATIVE Phase IIb clinical trial including new data on:
    • Efficacy of lanifibranor on key endpoints in Type-2 diabetic (TD2M) vs. non-diabetic patients
    • Efficacy of lanifibranor on key endpoints in F2/F3 patients
    • Effect of lanifibranor on plasma biomarkers of liver necro-inflammation and fibrosis in non-cirrhotic NASH patients


Presentation #2
:

  • Title: “NASH field overview”
  • Speaker: Prof. Arun Sanyal, Virginia Commonwealth University, Member of Inventiva’s Scientific Advisory Board  
  • Topics covered: 
    • Status of the NASH landscape, including lessons learned from recent clinical trial results and interactions with the FDA
    • Comparison of NATIVE Phase IIb clinical trial results with other recent clinical trial results in the NASH field


Presentation #3
:

  • Title:  “Management of NASH patients”
  • Speaker:Prof. Kenneth Cusi, University of Florida, Investigator of the Phase II clinical trial evaluating lanifibranor in patients with TD2M and NAFLD
  • Topics covered: Successful management of NASH patients


The details to connect to the webcast are as follows:

  • Date: Monday, November 16, 2020  
  • Time: 4:00 pm - 5:30 pm (ET) / 10:00 pm - 11:30 pm (CET)  
  • Connection details :
    • Option #1 – Webcast: https://edge.media-server.com/mmc/p/uy4bgbir
    • Option #2 – Conference call:
      • France: +33 (0) 1 70 70 07 81
      • Belgium: +32 (0) 2 793 3847
      • Germany: +49 (0) 69 2222 2625
      • Netherlands: +31 (0) 20 795 6614
      • Switzerland: +41 (0) 44 580 7145
      • United Kingdom: +44 (0) 207 192 8338
      • United States: +1 646-741-3167
    •  
      • Access code: 5239026

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 the American Association for the Study of Liver Diseases (AASLD)1

AASLD is the leading organization of scientists and health care professionals committed to preventing and curing liver disease. AASLD fosters research that leads to improved treatment options for millions of liver disease patients. AASLD advances the science and practice of hepatology through educational conferences, training programs, professional publications, and partnerships with government agencies and sister societies.


About lanifibranor

Lanifibranor, Inventiva’s lead product candidate, is an orally-available small molecule that acts to induce anti-fibrotic, anti-inflammatory and beneficial vascular and metabolic changes in the body by activating all three peroxisome proliferator‑activated receptor (PPAR) isoforms, which are well‑characterized nuclear receptor proteins that regulate gene expression. Lanifibranor is a PPAR agonist that is designed to target all three PPAR isoforms in a moderately potent manner, with a well‑balanced activation of PPARα and PPARδ, and a partial activation of PPARγ. While there are other PPAR agonists that target only one or two PPAR isoforms for activation, lanifibranor is the only pan‑PPAR agonist in clinical development. Inventiva believes that lanifibranor’s moderate and balanced pan‑PPAR binding profile contributes to the favorable tolerability profile that has been observed in clinical trials and pre‑clinical studies to date.


About the NATIVE Phase IIb trial

The NATIVE (NAsh Trial to Validate IVA337 Efficacy) clinical trial was a 24-week randomized, double-blind, placebo-controlled Phase IIb clinical trial evaluating lanifibranor for the treatment of patients with NASH. The main purpose of the trial was to assess the efficacy of lanifibranor in improving liver inflammation and ballooning, the two histological markers included in the definition of the regulatory endpoint of NASH resolution. To be considered for inclusion, patients were required to have: a diagnosis of NASH confirmed by liver biopsy; a cumulative score of inflammation and ballooning (as measured using the SAF scoring system) of three or four out of four, indicating the presence of moderate to severe inflammation and ballooning; a steatosis score greater than or equal to one, indicating the presence of moderate to severe steatosis; and a fibrosis score less than four, indicating the absence of cirrhosis. The primary endpoint of the trial was a reduction in the combined inflammation and ballooning score of two points compared to baseline, with no worsening fibrosis, as measured by the SAF score. Secondary endpoints included NASH resolution, improvements in each of the steatosis, inflammation, ballooning and fibrosis scores from baseline as measured using the SAF score, improvements in various other fibrosis measures, improvements in several metabolic markers, improvements in steatosis, inflammation and ballooning as measured using the NAS score (NAFLD activity score), and safety.

The trial randomized 247 patients with NASH in 71 sites in Australia, Canada, Europe, Mauritius and the United States.


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. Inventiva recently announced positive topline data from its Phase IIb clinical trial evaluating lanifibranor for the treatment of patients with 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. At the end of 2019, Inventiva published positive results from its Phase IIa clinical trial evaluating odiparcil for the treatment of MPS VI adult patients. 

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 (Euronext: IVA – ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA). www.inventivapharma.com


Contacts

Inventiva
Frédéric Cren
Chairman & CEO
https://www.globenewswire.com/Tracker?data=SRcQ_RCttD4SHdENzOUxO2oKEKdA7......

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