Inventiva announces the decision by the investigator to reduce the number of patients in the ongoing Phase II trial evaluating lanifibranor in type 2 diabetes patients (T2DM) with Non-Alcoholic Fatty Liver Disease (NAFLD)

6 July 2020

Daix (France), July 6, 2020 – Inventiva (Euronext: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical need, today announced the decision by the investigator to reduce the number of patients to be enrolled in the investigator-initiated Phase II clinical trial of lanifibranor in patients with TD2M and NAFLD being conducted by Prof. Cusi at the University of Florida.

This trial aims to evaluate the metabolic effects of lanifibranor and its potential efficacy on liver triglycerides inT2DM patients with NAFLD and provide additional clinical data supporting lanifibranor’s potential for the treatment of NASH.

Originally, the trial was expected to enroll 64 patients to be treated with a single daily dose of lanifibranor (800 mg/day) or placebo for a 24-week period and 10 subjects in a healthy, non-obese control group. However, given the observed effects of lanifibranor in reducing steatosis during the Phase IIb NATIVE clinical trial evaluating lanifibranor for the treatment of NASH, the investigator Prof. Cusi has decided to reduce the number of patients to be evaluated to 34 patients from 64 originally, while maintaining the same statistical powering in the trial.

At present, this investigator-initiated trial has recruited 23 patients, 15 of which have completed the 24-week period of treatment. Results from this trial are currently expected in 2021. However, due to the COVID-19 pandemic, the recruitment and screening of new patients has been suspended at the University of Florida, where the trial is being conducted, and the results could therefore be delayed.

The table below sets forth data from the Phase IIb NATIVE clinical trial with respect to the pre-specified analysis of changes in CRN steatosis score in the subset of T2DM patients, as compared to the overall population of patients treated in the trial. These data contributed to the investigator’s decision to reduce target enrollment in the ongoing investigator-initiated NAFLD trial.

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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 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

About Inventiva
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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.

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