Daix (France), Long Island City (New York, United States), October 18, 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 needs, announced that five scientific abstracts have been selected for poster presentations during the upcoming The Liver Meeting 2021, organized by the American Association for the Study of Liver Diseases (AASLD) on November 12-15, 2021.
The first abstract focuses on the improvement of insulin resistance and the reversal to normoglycemia in patients with non-cirrhotic NASH and prediabetes treated with lanifibranor. Prediabetes, defined by fasting glucose levels, is a risk factor for cardiovascular disease (CVD). Based on Inventiva's NATIVE Phase IIb clinical trial evaluating lanifibranor in NASH, the authors show that markers of glucose metabolism improved in patients with non-cirrhotic NASH and prediabetes during treatment with lanifibranor.
The second abstract demonstrates the beneficial effect of lanifibranor on the reduction of hepatic steatosis and shows a correlation with markers of lipid and glucose metabolism. The authors explain that, during the NATIVE Phase IIb clinical trial, lanifibranor therapy induced a decrease of steatosis, as measured by the Controlled Attenuation Parameter (CAP, Fibroscan) method, consistent with the decrease of steatosis observed with histological grading.
The third abstract highlights the correlation between NASH resolution and fibrosis improvement following lanifibranor treatment. The results from the NATIVE Phase IIb clinical trial show that, following treatment at both doses of lanifibranor (800mg/daily and 1200mg/daily), NASH resolution responders were significantly more likely to also be fibrosis improvers. Such correlation was also observed between ballooning improvement and fibrosis improvement.
The fourth abstract focuses on the positive effect of lanifibranor therapy in reducing Liver Sinusoidal Endothelial Cell (LSEC) capillarization. Based on the results of the NATIVE Phase IIb clinical trial, the authors analysed the change in capillarization (measured by CD34 immunostaining) of LSEC in patients with NASH and an activity >3 according to the Steatosis Activity Fibrosis (SAF) score1. CD34 staining increased with inflammation grade and fibrosis progression. Lanifibranor showed a dose dependent reduction of CD34 staining which reached significance in the periportal area.
The fifth abstract demonstrates that lanifibranor improves NASH, fibrosis and diastolic dysfunction in a hamster model of diet-induced NASH and diastolic dysfunction. In a non-clinical study conducted in a hamster model of NASH and diastolic dysfunction induced by a diet rich in fat, cholesterol and fructose, the authors evaluated the effect of pan-PPAR agonist lanifibranor. The results show that lanifibranor significantly reduced lipids metabolism markers and reversed steatosis, inflammation and fibrosis while significantly improving diastolic dysfunction. This new data further supports the potential development of lanifibranor as a treatment for NASH patients with high risk of cardiovascular diseases. These abstracts will be available for viewing by attendees on the AASLD website and will also be featured in the October supplement of the scientific journal Hepatology.
About the American Association for the Study of Liver Diseases (AASLD)2
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.
Lanifibranor, Inventiva's lead product candidate, is an orally-available small molecule that acts to induce antifibrotic, 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 PPAR? and PPAR, and a partial activation of PPAR. 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 for the treatment of NASH. 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. The FDA has granted Breakthrough Therapy and Fast Track designation to lanifibranor for the treatment of NASH.
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 preclinical 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 both FDA Breakthrough Therapy and Fast Track designation for lanifibranor in the treatment of NASH. Lanifibranor is currently being evaluated in a pivotal Phase III clinical trial.
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 in 2019 and received both FDA Fast Track and Rare Paediatric Disease designation for odiparcil in MPS VI.
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.
Patricia L. Bank
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