Inventiva annonce que lanifibranor a atteint le critère principal et les critères secondaires clés de l’étude clinique de Phase IIb NATIVE dans la stéatohépatite non alcoolique (NASH)

15 juin 2020

Inventiva annonce que lanifibranor a atteint le critère principal et les critères secondaires clés de l’étude clinique de Phase IIb NATIVE dans la stéatohépatite non alcoolique (NASH)

15 juin 2020

Daix (France), le 15 juin 2020 – Inventiva (Euronext : IVA), société biopharmaceutique spécialisée dans le développement clinique de petites molécules administrées par voie orale pour le traitement de la stéatohépatite non alcoolique (NASH), des mucopolysaccharidoses (MPS) et d’autres maladies avec un besoin médical non satisfait significatif, publie aujourd’hui les résultats positifs de son étude clinique de Phase IIb NATIVE (NAsh Trial to Validate IVA337 Efficacy) évaluant lanifibranor dans le traitement de la NASH.

Dans cette étude clinique d’une durée de 24 semaines, lanifibranor, petite molécule administrée par voie orale et seul agoniste pan-PPAR6 actuellement en développement clinique pour le traitement de la NASH, a atteint le critère principal de l’étude dans la population ITT ayant reçu la dose de 1200mg/jour avec une diminution statistiquement significative (p = 0,004) d’au moins deux points du score SAF7 (combinant inflammation du foie et « ballooning »), relativement au score avant traitement, sans aggravation de la fibrose. 49% des patients du groupe recevant la dose de 1200mg/jour de lanifibranor ont atteint le critère d’évaluation principal, contre 27% dans le groupe placebo.

Lanifibranor a également atteint plusieurs critères secondaires clés, notamment :

  • La résolution de la NASH sans aggravation de la fibrose dans les deux groupes lanifibranor (800mg/jour et 1200mg/jour)
  • L’amélioration de la fibrose d’au moins un stade8 sans aggravation de la NASH dans le groupe recevant la dose de 1200mg/jour
  • La résolution de la NASH et l’amélioration de la fibrose dans les deux groupes lanifibranor (800mg/jour et 1200mg/jour)

Des résultats statistiquement significatifs ont également été obtenus dans les deux groupes lanifibranor (800mg/jour et 1200mg/jour) avec :

  • Des diminutions des niveaux d’insuline, de glucose à jeun et d’hémoglobine glyquée (HB1AC) chez les patients atteints de diabète de type 2
  • Des diminutions du niveau de triglycérides
  • Une augmentation du taux de cholestérol des lipoprotéines de haute densité (HDL)
  • Des diminutions des taux d’enzymes hépatiques (ALT, AST et GGT)

Avec ces résultats, lanifibranor est le premier candidat-médicament à obtenir des résultats statistiquement significatifs sur les deux critères principaux9 requis pour la demande d’une approbation accélérée auprès de la Food and Drug Administration (FDA) et de l’Agence européenne des médicaments (EMA) pendant le développement clinique de Phase III.

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Contacts

Inventiva
Frédéric Cren

Chief Executive Officer
info@inventivapharma.com
+33 3 80 44 75 00

Brunswick
Yannick Tetzlaff / Tristan Roquet Montegon

Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

Patti Bank
Managing Director
ICR Westwicke
Patti.Bank@westwicke.com
D 415-513-1284
San Francisco, CA
www.westwicke.com

[lvca_accordion][lvca_panel panel_id=”panel-5bc0ba5831260″ panel_title=”About Inventiva”]Inventiva is a biopharmaceutical company specialized in the development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators. Inventiva’s research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs.

Lanifibranor, its lead product, is an anti-fibrotic treatment acting on the three alpha, gamma and delta PPARs (peroxisome proliferator-activated receptors), which play key roles in controlling the fibrotic process. Its anti-fibrotic action targets two initial indications with substantial unmet medical need: NASH, a severe and increasingly prevalent liver disease already affecting over 30 million people in the United States, and systemic sclerosis, a disease with a very high mortality rate and for which there is no approved treatment to date.

Inventiva is also developing a second clinical program with odiparcil (IVA 336) for the treatment of patients with mucopolysaccaridosis type VI (or Maroteaux-Lamy syndrome), a rare and severe gene disease affecting children. Odiparcil has also the potential to address other MPS types, characterized by the accumulation of chondroitin or dermatan sulfate (MPS I or Hurler/Sheie syndrome, MPS II or Hunter syndrome, MPS IVa or Morquio syndrome and MPS VII or Sly syndrome). Inventiva is also developing a portfolio of early research projects in the field of oncology.

Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie in the field of oncology. Two strategic partnerships have also been established with world-class major pharmaceutical companies AbbVie and Boehringer Ingelheim in the fields of autoimmune diseases (specifically in psoriasis) and fibrosis respectively. These partnerships provide milestone payments to Inventiva upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on the products resulting from the partnerships.

Inventiva employs over 100 employees and owns R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. The Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms.[/lvca_panel][lvca_panel panel_id=”panel-5bc0ba5831260″ panel_title=”Important Notice”]This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development
plans, business and regulatory strategy, and anticipated future performance of Inventiva and of the market in which it operates. 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 candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, 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. Given these 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 “Document de référence” filed with the Autorité des Marchés Financiers on April 13, 2018 under n° R.18-013 for additional information in relation to such factors, risks and uncertainties.

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.[/lvca_panel][/lvca_accordion]

Contacts

Inventiva
Frédéric Cren

Chief Executive Officer
info@inventivapharma.com
+33 3 80 44 75 00

Brunswick
Yannick Tetzlaff, Tristan Roquet Montégon, Aude Lepreux
Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

Patti Bank
Managing Director
ICR Westwicke
Patti.Bank@westwicke.com
D 415-513-1284
San Francisco, CA
www.westwicke.com

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