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Inventiva annonce l ’avis positif du 4 ème et dernier DSMB de l’étude clinique de Phase IIb avec lanifibranor dans la NASH

10 septembre 2019

Daix (France), le 10 septembre 2019 – Inventiva (Euronext : IVA), société biopharmaceutique spécialisée dans le développement clinique de petites molécules administrées par voie orale pour le traitement de maladies dans les domaines de la fibrose, de la surcharge lysosomale et de l’oncologie, annonce aujourd’hui l’avis positif du quatrième et dernier Data Safety Monitoring Board (DSMB) de l’étude clinique de Phase IIb NATIVE évaluant lanifibranor dans la NASH. Aucun problème de sécurité n’a été constaté et, comme lors des trois premières réunions du DSMB, celle-ci a recommandé que l’étude se poursuive sans modification du protocole. Ces conclusions sont d’autant plus significatives que la revue des données de sécurité a porté sur 228 patients dont 139 patients traités pendant toute la durée de l’étude. Cette recommandation positive confirme le bon profil de sécurité de lanifibranor.

L’étude clinique de Phase IIb NATIVE (NAsh Trial to Validate IVA337 Efficacy) évalue lanifibranor, le candidat médicament le plus avancé de la Société, dans le traitement de la stéatose hépatique non-alcoolique (NASH), une maladie hépatique chronique et progressive pour laquelle il n’existe actuellement aucun traitement approuvé. Suite aux conclusions positives du dernier DSMB et la fin du recrutement des patients dans l’étude annoncée le 4 septembre 2019, Inventiva confirme la publication des résultats de l’étude au 1er semestre 2020.

Pierre Broqua, Directeur Scientifique et cofondateur d’Inventiva, a commenté : « Nous sommes particulièrement satisfaits par le profil de sécurité de lanifibranor auprès des patients atteints de la NASH. L’avis positif du DSMB ainsi que la décision de la FDA de lever pour lanifibranor la suspension clinique applicable aux agonistes PPAR nous confortent quant au mécanisme d’action unique de notre candidat médicament. Nous attendons avec impatience la publication, au premier semestre 2020, des résultats de l’étude et, s’ils sont positifs, le démarrage de la dernière phase de développement avant la mise sur le marché de lanifibranor. »


Frédéric Cren

Chief Executive Officer
+33 3 80 44 75 00

Yannick Tetzlaff / Tristan Roquet Montegon

Media relations
+33 1 53 96 83 83

LifeSci Advisors
Monique Kosse

Investor relations

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.

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.

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