Inventiva announces further progress achieved in the clinical development of lanifibranor for the treatment of NASH

• First patient screened in the United States for the NATIVE trial in NASH
   
• 155 patients randomized to date, 70% of the total target
   

Results for the NATIVE trial in NASH expected in the first half of 2020
 

Second DSMB meeting recommends that the trial continue as planned

             
Daix (France) February 21st, 2019 - Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, today announced the screening of the first patient in the United States for its Phase IIb NATIVE (NASH Trial to Validate IVA337 Efficacy) clinical trial evaluating lanifibranor, the Company's lead product candidate, for the treatment of non-alcoholic steatohepatitis (NASH), a common and progressive chronic liver disease for which there is currently no approved therapy. Inventiva also announced that the NATIVE Data Safety Monitoring Board (DSMB) held its second meeting and recommended that the trial continue as planned.

The screening of the first patient in the United States follows the positive review by the U.S. Food and Drug Administration (FDA) of the NATIVE trial protocol and the inclusion of 14 sites in the United States in the trial, which brought the total number of sites involved to 91. Out of 225 patients expected to be enrolled in the trial, 155 patients have been randomized, and 71 patients have already completed the six-months treatment. The NATIVE trial continues to progress as planned and results are anticipated in the first half of 2020.

Pr Sven Francque, M.D., Ph.D. from the Antwerp University Hospital and Co-Principal Investigator, said: "The news of the first patient screened in the U.S. and the opening of 14 sites represents great progress. We expect to open 5 additional sites in Europe to further accelerate patient recruitment. Given the study design and lanifibranor's mechanism of action, we believe that the results of the NATIVE trial, if positive, will support lanifibranor's move into the pivotal Phase III trial."