- Two late-breaking abstracts covering new data from Inventiva’s NATIVE Phase IIb clinical trial evaluating lanifibranor for the treatment of NASH have been selected for poster presentations during the congress
- These abstracts focus on the efficacy of lanifibranor in type-2 diabetic (TD2M) patients and its positive effect on key plasma biomarkers
- Presence during the congress will be highlighted with an oral plenary presentation and include a total of four presentations/abstracts
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The two late-breaking abstracts cover new data from the Company’s NATIVE Phase IIb clinical trial evaluating lanifibranor for the treatment of NASH, focusing on the efficacy of lanifibranor in type-2 diabetic (TD2M) patients and its positive effect on key plasma biomarkers.
A third abstract covering the screening methodology used for patient selection during the NATIVE Phase IIb clinical trial has also been accepted for a poster presentation.
These three abstracts complement Inventiva’s presence at the AASLD The Liver Meeting Digital Experience™ 2020, where
The details of the various presentations are as follows:
Late-breaking abstract #1:
Abstract title: | “Efficacy of the panPPAR agonist lanifibranor on the histological endpoints NASH resolution and fibrosis regression is similar in type-2 diabetic and non-diabetic patients: additional results of the NATIVE Phase IIb trial in non-cirrhotic NASH " |
Publication number: | LP9 |
Session title: | Late-breaking Abstract Posters |
Presentation type: | Poster presentation |
Author: | Prof. |
The abstract will also be featured in the December issue of the scientific journal Hepatology and is available on the website of the AASLD.
Late-breaking abstract #2:
Abstract title: | “Effect of the panPPAR agonist lanifibranor on plasma biomarkers of liver necro-inflammation and fibrosis in non-cirrhotic NASH patients: additional results of the NATIVE Phase IIb trial" |
Publication number: | LP36 |
Session title: | Late-breaking Abstract Posters |
Presentation type: | Poster presentation |
Author: | Prof. |
The abstract will also be featured in the December issue of the scientific journal Hepatology and is available on the website of the AASLD.
Abstract #3:
Abstract title: | “Selection based on SAF activity score, not NASH CRN NAFLD activity score, leads to selection of a patient cohort with more severe NASH with more advanced fibrosis: experience from the NATIVE Phase IIb study of the panPPAR agonist lanifibranor" |
Publication number: | 1696 |
Session title: | NAFLD and NASH: Therapeutics - Pharmacologic and Other |
Presentation type: | Poster presentation |
Author: | Prof. |
Oral plenary presentation:
Abstract title: | "The panPPAR agonist lanifibranor induces both resolution of NASH and regression of fibrosis after 24 weeks of treatment in non-cirrhotic NASH: results of the NATIVE Phase IIb trial" |
Publication number: | 0012 |
Session title: | Plenary: Clinical and Outcomes Discoveries |
Presentation type: | Oral presentation, Plenary Session |
Presenting author: | Prof. |
Date: | |
Session time: |
The content of the presentation will also be part of a dedicated Key Opinion Leader (KOL) webcast focused on NASH and hosted by
About the
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. We advance 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.
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
About
Leveraging its expertise and experience in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation,
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 parallel,
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.
Contacts
Chairman & CEO
info@inventivapharma.com
+33 3 80 44 75 00
Aude Lepreux
Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83
Westwicke, an
Investor relations
patti.bank@westwicke.com
+1 415 513 1284
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
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1 https://www.aasld.org/
Attachment
Inventiva - PR - AASLD Abstract - EN - 30 10 2020
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