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)
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.Télécharger PDF